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Compound · clinical trials

5-FU clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 88 trials in our China, USA, Japan, Italy, Germany, Canada, Mexico, South Korea, Taiwan, France, Spain, UK, Israel, Australia, Netherlands, Poland, Brazil, Norway, Turkey, Czechia, Denmark, Belgium, Switzerland, Sweden, Egypt, Portugal, Singapore, India and Austria registers that name 5-FU as an intervention. Synced 26 Sep 2026
88Current trials
50Recruiting now
59Lead sponsors
29Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

5-FU is named as an intervention in 88 current clinical trials in our China, USA, Japan, Italy, Germany, Canada, Mexico, South Korea, Taiwan, France, Spain, UK, Israel, Australia, Netherlands, Poland, Brazil, Norway, Turkey, Czechia, Denmark, Belgium, Switzerland, Sweden, Egypt, Portugal, Singapore, India and Austria registers. 50 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is National Cancer Institute (NCI) (8). The most-studied condition is Colorectal Cancer.

Trials by status

  • Recruiting5057%
  • Not yet open78%
  • Active, closed3135%

Trials by phase

  • Phase 33034%
  • Phase 23034%
  • Phase 1/21315%
  • Phase 1910%
  • Phase 2/333%
  • Not applicable22%
  • Phase 411%
01

Clinical trials of 5-FU

88 trials
StudyPhaseStatusLead sponsorRegisters
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
NCT06499415 · ClinicalTrials.gov ↗ · Actinic Keratoses
Phase 4 Recruiting Maastricht University Medical Center Netherlands
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
NCT02535221 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Recruiting Peking University China
Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver
NCT02885753 · ClinicalTrials.gov ↗ · Colorectal Neoplasms
Phase 3 Recruiting Federation Francophone de Cancerologie Digestive France, Belgium
A Study of 2nd-line FOLFIRI ยฑ Bevacizumab vs. Irinotecan ยฑ Bevacizumab in mCRC
NCT03303495 · ClinicalTrials.gov ↗ · Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms
Phase 3 Recruiting Sun Yat-sen University China
HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)
NCT04447352 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Phase 3 Recruiting Krankenhaus Nordwest Germany
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
NCT04495088 · ClinicalTrials.gov ↗ · Rectal Cancer
Phase 3 Recruiting Ralf Hofheinz Germany
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
NCT04997837 · ClinicalTrials.gov ↗ · Gastric Cancer
Phase 3 Recruiting Fudan University China
Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
NCT05008809 · ClinicalTrials.gov ↗ · Colorectal Cancer
Phase 3 Recruiting Dominik Paul Modest Germany
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
NCT05677490 · ClinicalTrials.gov ↗ · Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
Phase 3 Recruiting Alliance for Clinical Trials in Oncology Mexico
Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
NCT06509126 · ClinicalTrials.gov ↗ · Colorectal Cancer Stage IV
Phase 3 Recruiting National Cancer Institute, Naples Italy
FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.
NCT06733038 · ClinicalTrials.gov ↗ · Colorectal Cancer
Phase 3 Recruiting Gruppo Oncologico del Nord-Ovest Italy
Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.
NCT06897644 · ClinicalTrials.gov ↗ · Pancreatic Adenocarcinoma Advanced or Metastatic
Phase 3 Recruiting Gruppo Oncologico del Nord-Ovest Italy
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
NCT06901531 · ClinicalTrials.gov ↗ · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer
Phase 3 Recruiting Astellas Pharma Global Development, Inc UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Czechia, Portugal, Turkey, Brazil, Mexico, Japan, South Korea, Taiwan, Australia
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
NCT06958328 · ClinicalTrials.gov ↗ · Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
Phase 3 Recruiting NRG Oncology Canada
A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07043400 · ClinicalTrials.gov ↗ · Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Phase 3 Recruiting BeOne Medicines UK, USA, China, France, Spain, Italy, Poland, Austria, Czechia, Turkey, Brazil, Mexico, Japan, South Korea
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
NCT07271355 · ClinicalTrials.gov ↗ · Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum
Phase 3 Recruiting City of Hope Medical Center Egypt
A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer
NCT07673887 · ClinicalTrials.gov ↗ · Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
Phase 3 Recruiting Astellas Pharma Global Development, Inc USA, Japan
Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
NCT06280495 · ClinicalTrials.gov ↗ · Colorectal Cancer, Liver Metastases
Phase 2/3 Recruiting Sun Yat-sen University China
Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery
NCT04452461 · ClinicalTrials.gov ↗ · Pancreatic Adenocarcinoma
Phase 2 Recruiting Hamilton Health Sciences Corporation Canada
ATATcH Alternating Treatment Plans for Advanced Cancer
NCT05358548 · ClinicalTrials.gov ↗ · Head and Neck Cancer, Lung Cancer
Phase 2 Recruiting Rutgers, The State University of New Jersey Israel
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
NCT05472259 · ClinicalTrials.gov ↗ · Metastatic Pancreatic Ductal Adenocarcinoma
Phase 2 Recruiting Belgian Group of Digestive Oncology Belgium
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
NCT05564377 · ClinicalTrials.gov ↗ · Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Phase 2 Recruiting National Cancer Institute (NCI) Mexico, Israel, Egypt
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
NCT06219941 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer
Phase 2 Recruiting AstraZeneca UK, USA, China, Spain, Poland, Canada, Japan, South Korea, Taiwan, Singapore, Australia
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
NCT06341296 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer
Phase 2 Recruiting West China Hospital China
Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
NCT06535607 · ClinicalTrials.gov ↗ · Sub-study 1 Cervical Cancer (Volrustomig Monotherapy), Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy), Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)
Phase 2 Recruiting AstraZeneca UK, USA, China, Germany, Italy, Canada, Brazil, Japan, South Korea, Taiwan, Australia
Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma
NCT06632717 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma
Phase 2 Recruiting National Taiwan University Hospital Taiwan
First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
NCT06730373 · ClinicalTrials.gov ↗ · HER2-positive Gastric Cancer, Metastatic Gastric Cancer, Unresectable Gastric Carcinoma
Phase 2 Recruiting Qilu Hospital of Shandong University China
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
NCT06770582 · ClinicalTrials.gov ↗ · Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v8
Phase 2 Recruiting National Cancer Institute (NCI) Canada
An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
NCT07018570 · ClinicalTrials.gov ↗ · Gastroesophageal Junction (GEJ) Adenocarcinoma
Phase 2 Recruiting National Cancer Center Hospital East Japan
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
NCT07069712 · ClinicalTrials.gov ↗ · Gastroesophageal Adenocarcinoma
Phase 2 Recruiting AstraZeneca UK, USA, China, Spain, Italy, Poland, Turkey, Canada, Japan, Taiwan
Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
NCT07150247 · ClinicalTrials.gov ↗ · BRAF V600 Colorectal Cancer
Phase 2 Recruiting Sun Yat-sen University China
A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
NCT07474727 · ClinicalTrials.gov ↗ · Colorectal Cancer
Phase 2 Recruiting Multitude Therapeutics Inc China
A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
NCT07484724 · ClinicalTrials.gov ↗ · Advanced Esophageal Squamous Cell Carcinoma
Phase 2 Recruiting Shanghai Junshi Bioscience Co., Ltd China
A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
NCT07554521 · ClinicalTrials.gov ↗ · Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Advanced Gastroesophageal Adenocarcinoma
Phase 2 Recruiting BeOne Medicines USA
SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma
NCT07700667 · ClinicalTrials.gov ↗ · Esophageal Squamous Cell Carcinoma
Phase 2 Recruiting Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd China
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
NCT07733180 · ClinicalTrials.gov ↗ · Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
Phase 2 Recruiting BeOne Medicines Japan
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
NCT06428409 · ClinicalTrials.gov ↗ · Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer
Phase 1/2 Recruiting Merck Sharp & Dohme LLC UK, USA, China, Spain, Italy, Switzerland, Turkey, Canada, Japan, South Korea, Taiwan, Australia
Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
NCT06469944 · ClinicalTrials.gov ↗ · Gastroesophageal Junction, Gastroesophageal Adenocarcinoma, Esophageal Neoplasms
Phase 1/2 Recruiting Merck Sharp & Dohme LLC USA, China, Germany, France, Italy, Switzerland, Norway, Brazil, South Korea, Taiwan
A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors
NCT06741644 · ClinicalTrials.gov ↗ · Advanced Solid Tumors
Phase 1/2 Recruiting CStone Pharmaceuticals USA, China, Australia
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
NCT06780111 · ClinicalTrials.gov ↗ · Esophageal Squamous Cell Carcinoma
Phase 1/2 Recruiting Merck Sharp & Dohme LLC USA, China, Germany, France, Italy, Switzerland, Czechia, Norway, Turkey, Brazil, Japan, South Korea, Taiwan, Singapore
Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV
NCT06782685 · ClinicalTrials.gov ↗ · Advanced Pancreatic Cancer (Part 1)
Phase 1/2 Recruiting Dai, Guanghai China
AK129 Combination Therapy for Advanced Solid Tumors
NCT06943820 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Adenocarcinoma
Phase 1/2 Recruiting Akeso China
Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer
NCT07056777 · ClinicalTrials.gov ↗ · Gastrointestinal Cancer
Phase 1/2 Recruiting Zhejiang Doer Biologics Co., Ltd China
A Study of YL242 in Subjects With Advanced Solid Tumors
NCT07197827 · Advanced Solid Tumor
Phase 1/2 Recruiting MediLink Therapeutics (Suzhou) Co., Ltd USA, China, Australia
A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors
NCT07256782 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Phase 1/2 Recruiting Qilu Pharmaceutical Co., Ltd China
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
NCT06131840 · ClinicalTrials.gov ↗ · Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
Phase 1 Recruiting Seagen, a wholly owned subsidiary of Pfizer UK, USA, China, France, Spain, Netherlands, Sweden, Canada, Japan, Israel
ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer
NCT06825624 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer (CRC)
Phase 1 Recruiting Hansoh BioMedical R&D Company China
The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
NCT06856447 · ClinicalTrials.gov ↗ · Colorectal Cancer
Phase 1 Recruiting toqa saad mohammed mohammed Egypt
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
NCT07024615 · ClinicalTrials.gov ↗ · Pancreatic Ductal Adenocarcinoma
Phase 1 Recruiting Astellas Pharma Global Development, Inc USA
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
NCT07283939 · ClinicalTrials.gov ↗ · Ampulla of Vater Carcinoma, Appendix Carcinoma, Carcinoma of Unknown Primary With Gastrointestinal Profile
Not applicable Recruiting Alliance for Clinical Trials in Oncology Mexico
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial of Leucogen Versus Placebo on Leukocyte and Platelet Whole-course Management Assisted by PFLL Chemotherapy in the Treatment of Stage IV, Recurrent or Metastatic NPC
NCT05780294 · ClinicalTrials.gov ↗ · Nasopharyngeal Carcinoma, Leucogen, Chemotherapy
Phase 3 Not yet open Sun Yat-sen University China
Pre-Operative Treatment in REseCTable COlon CanceR
NCT06899477 · ClinicalTrials.gov ↗ · Colo-rectal Cancer, Colon Cancer, Colon Carcinoma
Phase 3 Not yet open Dominik Paul Modest Germany
Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
NCT07472868 · ClinicalTrials.gov ↗ · Locally Advanced Rectal Carcinoma
Phase 3 Not yet open J. W. A. Burger Netherlands
Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ยฑ Lenvatinib As First-line Treatment for Advanced ICC
NCT06648525 · ClinicalTrials.gov ↗ · Intrahepatic Cholangiocarcinoma (Icc)
Phase 2 Not yet open Harbin Medical University China
Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC
NCT06684158 · ClinicalTrials.gov ↗ · GC/GEJC
Phase 2 Not yet open The First Affiliated Hospital with Nanjing Medical University China
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
NCT06370754 · ClinicalTrials.gov ↗ · Pancreatic Cancer
Phase 1/2 Not yet open Fudan University China
NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer
NCT07314385 · ClinicalTrials.gov ↗ · Pancreatic Adenocarcinoma Metastatic, Liver Metastasis
Phase 1 Not yet open National Taiwan University Hospital Taiwan
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT00588770 · ClinicalTrials.gov ↗ · Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma
Phase 3 Active, closed National Cancer Institute (NCI) Mexico, Israel
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
NCT02912559 · ClinicalTrials.gov ↗ · Colon Adenocarcinoma, DNA Repair Disorder, Lynch Syndrome
Phase 3 Active, closed National Cancer Institute (NCI) Germany, Mexico, Israel
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study
NCT02997228 · ClinicalTrials.gov ↗ · Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
Phase 3 Active, closed National Cancer Institute (NCI) Mexico
Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT
NCT03340896 · ClinicalTrials.gov ↗ · Head and Neck Squamous Cell Carcinoma
Phase 3 Active, closed Groupe Oncologie Radiotherapie Tete et Cou France
Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery
NCT03533582 · ClinicalTrials.gov ↗ · Childhood Hepatocellular Carcinoma, Childhood Malignant Liver Neoplasm, Fibrolamellar Carcinoma
Phase 3 Active, closed Children's Oncology Group Canada, Mexico, Australia, Israel
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
NCT03775265 · ClinicalTrials.gov ↗ · Bladder Urothelial Carcinoma, Muscle Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8
Phase 3 Active, closed National Cancer Institute (NCI) Norway
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
NCT04241185 · ClinicalTrials.gov ↗ · Urinary Bladder Neoplasms
Phase 3 Active, closed Merck Sharp & Dohme LLC UK, USA, France, Spain, Italy, Netherlands, Denmark, Poland, Czechia, Portugal, Turkey, Japan, South Korea, Taiwan, Australia, Israel
Short RT Versus RCT,Followed by Chemo and Organ Preservation for Interm and High-risk Rectal Cancer Patients
NCT04246684 · ClinicalTrials.gov ↗ · Rectal Cancer Stage III
Phase 3 Active, closed Prof. Dr. med. Claus Rรถdel Germany
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
NCT04607421 · Neoplasms
Phase 3 Active, closed Pfizer UK, USA, India, China, Germany, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Poland, Czechia, Norway, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia
Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
NCT04776655 · ClinicalTrials.gov ↗ · Colorectal Cancer, Metastatic Colorectal Cancer, RAS Mutation
Phase 3 Active, closed Azienda USL Reggio Emilia - IRCCS Italy
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
NCT05239741 · ClinicalTrials.gov ↗ · Colorectal Neoplasms
Phase 3 Active, closed Merck Sharp & Dohme LLC China
Nordic Pancreatic Cancer Trial (NorPACT) - 1
NCT02919787 · ClinicalTrials.gov ↗ · Pancreatic Cancer
Phase 2/3 Active, closed Oslo University Hospital Sweden, Denmark, Norway
Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
NCT04068103 · ClinicalTrials.gov ↗ · Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v8
Phase 2/3 Active, closed NRG Oncology Canada, Mexico
Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness
NCT03421288 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Phase 2 Active, closed Institut fรผr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Germany, Switzerland
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
NCT04166318 · ClinicalTrials.gov ↗ · Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Anal Canal Squamous Cell Carcinoma
Phase 2 Active, closed ECOG-ACRIN Cancer Research Group Mexico, Israel
A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial
NCT04216290 · ClinicalTrials.gov ↗ · Bladder Urothelial Carcinoma, Stage III Bladder Cancer AJCC v8
Phase 2 Active, closed National Cancer Institute (NCI) Mexico
Trial of Nivolumab and Cetuximab After Chemoradiation in Esophageal Squamous Cell Carcinoma Patients.
NCT04229459 · ClinicalTrials.gov ↗ · Esophageal Squamous Cell Carcinoma
Phase 2 Active, closed Baruch Brenner Israel
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT04233866 · ClinicalTrials.gov ↗ · Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
Phase 2 Active, closed ECOG-ACRIN Cancer Research Group Mexico
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
NCT04379596 · ClinicalTrials.gov ↗ · Gastric Cancer
Phase 2 Active, closed AstraZeneca UK, USA, China, Germany, Spain, Italy, Netherlands, Poland, Canada, Brazil, Japan, South Korea, Taiwan
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
NCT05564403 · ClinicalTrials.gov ↗ · Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma, Advanced Intrahepatic Cholangiocarcinoma
Phase 2 Active, closed National Cancer Institute (NCI) Mexico
Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer
NCT05843188 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer
Phase 2 Active, closed University Health Network, Toronto Canada
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
NCT05945823 · ClinicalTrials.gov ↗ · Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer
Phase 2 Active, closed Taiho Oncology, Inc USA, Germany, France, Spain
Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas
NCT06557889 · ClinicalTrials.gov ↗ · Squamous Cell Carcinoma of Head and Neck
Phase 2 Active, closed Institut Claudius Regaud France
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
NCT04083599 · Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Phase 1/2 Active, closed Genmab UK, USA, China, Germany, France, Spain, Italy, Denmark, South Korea, Taiwan, Israel
Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer
NCT04821284 · ClinicalTrials.gov ↗ · Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8
Phase 1/2 Active, closed Flemming Forsberg Norway
Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
NCT06771622 · ClinicalTrials.gov ↗ · Solid Cancer
Phase 1/2 Active, closed FBD Biologics Limited China
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
NCT03872947 · ClinicalTrials.gov ↗ · Solid Tumor, Colorectal Cancer, Cholangiocarcinoma
Phase 1 Active, closed Toray Industries, Inc USA, France
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
NCT05464030 · ClinicalTrials.gov ↗ · Colorectal Cancer
Phase 1 Active, closed EMD Serono Research & Development Institute, Inc USA, Spain, Canada, Japan, South Korea
First in Human Study of AZD9592 in Solid Tumors
NCT05647122 · ClinicalTrials.gov ↗ · Advanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms
Phase 1 Active, closed AstraZeneca USA, China, France, Spain, Italy, Canada, Japan, South Korea, Taiwan, Australia
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
NCT06547385 · ClinicalTrials.gov ↗ · Colorectal Cancer
Phase 1 Active, closed Ono Pharmaceutical Co., Ltd Japan
Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma
NCT03306901 · ClinicalTrials.gov ↗ · Esophageal Cancer
Not applicable Active, closed Samsung Medical Center South Korea

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with 5-FU

143 conditions
All 143 conditions
Condition (as registered)Trials
Colorectal Cancer10
Colorectal Neoplasms5
Gastric Cancer5
Pancreatic Ductal Adenocarcinoma4
Esophageal Squamous Cell Carcinoma4
Gastroesophageal Junction Adenocarcinoma3
Metastatic Colorectal Cancer3
Gastroesophageal Adenocarcinoma2
Biliary Tract Cancer2
Advanced Solid Tumor2
Advanced Solid Tumors2
Gastroesophageal Junction (GEJ) Adenocarcinoma2
Esophageal Cancer2
Pancreatic Cancer2
Advanced Esophageal Squamous Cell Carcinoma2
Colon Adenocarcinoma2
Colon Carcinoma2
Metastatic Pancreatic Ductal Adenocarcinoma2
Stage II Pancreatic Cancer AJCC v82
Bladder Urothelial Carcinoma2
Stage IV Pancreatic Cancer AJCC v82
Malignant Solid Tumor1
Non-Small Cell Lung Cancer (NSCLC)1
Colorectal Cancer (CRC)1
Melanoma1
Neoplasms1
Carcinoma, Non-Small-Cell Lung1
Stomach Neoplasms1
Urinary Bladder Neoplasms1
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer1
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer1
Metastatic Gastric Adenocarcinoma or Cancer1
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma1
Sub-study 1 Cervical Cancer (Volrustomig Monotherapy)1
Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy)1
Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)1
Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)1
Gastroesophageal Junction Cancer1
Metastatic Gastric Adenocarcinoma1
Gastric Adenocarcinoma1
Advanced Unresectable Gastric Adenocarcinoma1
Advanced Gastroesophageal Adenocarcinoma1
Gastroesophageal Junction1
Esophageal Neoplasms1
Solid Tumor1
Cholangiocarcinoma1
Bladder Cancer1
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1
Esophageal Adenocarcinoma1
Esophageal Squamous Cell Cancer1
Siewert Type 1 GEJ Cancer1
Advanced Solid Tumours1
Carcinoma Non-small Cell Lung1
Head and Neck Neoplasms1
Nasopharyngeal Carcinoma1
Leucogen1
Chemotherapy1
Myelosuppression1
Liver Metastases1
Gastrointestinal Cancer1
Breast Cancer1
Advanced Pancreatic Cancer (Part 1)1
Neoplasm Metastasis1
Intestinal Neoplasms1
Gastrointestinal Neoplasms1
Non-small Cell Lung Cancer Stage IIIB/IV1
Head and Neck Squamous Cell Carcinoma (HNSCC)1
Colorectal Adenocarcinoma1
Intrahepatic Cholangiocarcinoma (Icc)1
Metastatic Colorectal Cancer (CRC)1
BRAF V600 Colorectal Cancer1
GC/GEJC1
Solid Cancer1
HER2-positive Gastric Cancer1
Metastatic Gastric Cancer1
Unresectable Gastric Carcinoma1
Rectal Cancer Stage III1
Rectal Cancer1
DNA Repair Disorder1
Lynch Syndrome1
Stage III Colon Cancer AJCC v81
Colo-rectal Cancer1
Colon Cancer1
Head and Neck Squamous Cell Carcinoma1
Squamous Cell Carcinoma of Head and Neck1
RAS Mutation1
Colorectal Cancer Stage IV1
Pancreatic Adenocarcinoma Advanced or Metastatic1
Actinic Keratoses1
Locally Advanced Rectal Carcinoma1
Locally Advanced Pancreatic Ductal Adenocarcinoma1
Stage IIA Pancreatic Cancer AJCC v81
Muscle Invasive Bladder Carcinoma1
Stage II Bladder Cancer AJCC v81
Stage IIIA Bladder Cancer AJCC v81
Stage IIA Colon Cancer AJCC v81
Childhood Hepatocellular Carcinoma1
Childhood Malignant Liver Neoplasm1
Fibrolamellar Carcinoma1
Hepatoblastoma1
Pancreatic Adenocarcinoma1
Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma1
Stage III Pancreatic Cancer AJCC v81
Non-Muscle Invasive Bladder Urothelial Carcinoma1
Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma1
Stage I Bladder Cancer AJCC v81
Anal Basaloid Carcinoma1
Anal Canal Cloacogenic Carcinoma1
Anal Canal Squamous Cell Carcinoma1
Anal Margin Squamous Cell Carcinoma1
Metastatic Colorectal Adenocarcinoma1
Stage IV Colorectal Cancer AJCC v71
Advanced Biliary Tract Carcinoma1
Advanced Gallbladder Carcinoma1
Advanced Intrahepatic Cholangiocarcinoma1
Recurrent Biliary Tract Carcinoma1
Stage III Bladder Cancer AJCC v81
Advanced Malignant Solid Neoplasm1
Anatomic Stage III Breast Cancer AJCC v81
Anatomic Stage IV Breast Cancer AJCC v81
Locally Advanced Malignant Solid Neoplasm1
Neck Squamous Cell Carcinoma of Unknown Primary1
Recurrent Hypopharyngeal Squamous Cell Carcinoma1
Recurrent Laryngeal Squamous Cell Carcinoma1
Recurrent Laryngeal Verrucous Carcinoma1
Advanced Esophageal Adenocarcinoma1
Advanced Gastric Adenocarcinoma1
Advanced Gastroesophageal Junction Adenocarcinoma1
Clinical Stage III Esophageal Adenocarcinoma AJCC v81
Ampulla of Vater Carcinoma1
Appendix Carcinoma1
Carcinoma of Unknown Primary With Gastrointestinal Profile1
Metastatic Pancreatic Adenocarcinoma1
Metastatic Esophageal Squamous Cell Carcinoma1
Pancreatic Adenocarcinoma Metastatic1
Liver Metastasis1
Hepatocellular Carcinoma1
Head and Neck Cancer1
Lung Cancer1
Metastatic Appendix Carcinoma1
Metastatic Colorectal Carcinoma1
Metastatic Malignant Neoplasm in the Peritoneum1
Stage IV Appendix Carcinoma AJCC v81
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
National Cancer Institute (NCI)8
Merck Sharp & Dohme LLC5
AstraZeneca5
Sun Yat-sen University4
Astellas Pharma Global Development, Inc3
BeOne Medicines3
Fudan University2
Dominik Paul Modest2
Gruppo Oncologico del Nord-Ovest2
NRG Oncology2
ECOG-ACRIN Cancer Research Group2
Alliance for Clinical Trials in Oncology2
National Taiwan University Hospital2
Genmab1
Pfizer1

+ 44 more sponsors in the trial list above.

04

By country register

RegisterTrialsRecruiting
Clinical trials in China3626
Clinical trials in USA2214
Clinical trials in Japan1711
Clinical trials in Italy1610
Clinical trials in Germany157
Clinical trials in Canada158
Clinical trials in Mexico155
Clinical trials in South Korea147
Clinical trials in Taiwan148
Clinical trials in France136
Clinical trials in Spain136
Clinical trials in UK117
Clinical trials in Israel103
Clinical trials in Australia106
Clinical trials in Netherlands73
Clinical trials in Poland74
Clinical trials in Brazil75
Clinical trials in Norway62
Clinical trials in Turkey65
Clinical trials in Czechia53
Clinical trials in Denmark40
Clinical trials in Belgium43
Clinical trials in Switzerland43
Clinical trials in Sweden31
Clinical trials in Egypt33
Clinical trials in Portugal21
Clinical trials in Singapore22
Clinical trials in India10
Clinical trials in Austria11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about 5-FU trials

How many clinical trials are testing 5-FU?

88 current trials in our China, USA, Japan, Italy, Germany, Canada, Mexico, South Korea, Taiwan, France, Spain, UK, Israel, Australia, Netherlands, Poland, Brazil, Norway, Turkey, Czechia, Denmark, Belgium, Switzerland, Sweden, Egypt, Portugal, Singapore, India and Austria registers name 5-FU as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are 5-FU trials recruiting patients?

Yes. 50 of the 88 trials are recruiting: 26 with sites in China, 14 with sites in USA, 11 with sites in Japan, 10 with sites in Italy, 7 with sites in Germany, 8 with sites in Canada, 5 with sites in Mexico, 7 with sites in South Korea, 8 with sites in Taiwan, 6 with sites in France, 6 with sites in Spain, 7 with sites in UK, 3 with sites in Israel, 6 with sites in Australia, 3 with sites in Netherlands, 4 with sites in Poland, 5 with sites in Brazil, 2 with sites in Norway, 5 with sites in Turkey, 3 with sites in Czechia, 3 with sites in Belgium, 3 with sites in Switzerland, 1 with sites in Sweden, 3 with sites in Egypt, 1 with sites in Portugal, 2 with sites in Singapore and 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors 5-FU clinical trials?

National Cancer Institute (NCI) (8), Merck Sharp & Dohme LLC (5), AstraZeneca (5) and Sun Yat-sen University (4), among 59 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how 5-FU works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how 5-FU works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists 5-FU (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.