Compound · clinical trials

Cadonilimab clinical trials

Also listed in trial records as AK104

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 87 trials in our China, USA, Germany, Poland and Australia registers that name Cadonilimab as an intervention. Synced 9 Nov 2026

87Current trials

56Recruiting now

48Lead sponsors

5Country registers

Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from ClinicalTrials.gov registry records · Synced 9 Nov 2026 · Editorial standards

At a glance

Cadonilimab is named as an intervention in 87 current clinical trials in our China, USA, Germany, Poland and Australia registers. 56 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Akeso (23). The most-studied condition is Hepatocellular Carcinoma.

How Cadonilimab works

All drug targets →

Programmed cell death protein 1 inhibitor Inhibitor
Target: PDCD1 programmed cell death 1
✓ In ChEMBL and the Guide to Pharmacology
Cytotoxic T-lymphocyte protein 4 inhibitor Inhibitor
Target: CTLA4 cytotoxic T-lymphocyte associated protein 4
✓ In ChEMBL and the Guide to Pharmacology

Other medicines acting on PDCD1

Pembrolizumab Nivolumab Tislelizumab Sintilimab Toripalimab Camrelizumab Serplulimab Cemiplimab Dostarlimab Pucotenlimab Zimberelimab Penpulimab +8 more

Other medicines acting on CTLA4

Ipilimumab Tremelimumab KN046 Zalifrelimab

Diseases it has been tested for in clinical trials, by furthest phase

Cervical cancerPhase 3
Colon carcinomaPhase 3
Colorectal cancerPhase 3
Gastric adenocarcinomaPhase 3
Gastroesophageal junction adenocarcinomaPhase 3
Hepatocellular carcinomaPhase 3
Malignant colon neoplasmPhase 3
Nasopharyngeal carcinomaPhase 3
Non-small cell lung carcinomaPhase 3
Ovarian cancerPhase 3

51 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594456, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12966, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Cadonilimab

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

UK
United Kingdom: Search MHRA Products
Patient information leaflets and SmPCs for UK-licensed products.
US
United States: Search DailyMed
FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

Recruiting5664%
Not yet open1113%
Active, closed1821%
By invitation22%

Trials by phase

Phase 24956%
Phase 31517%
Phase 1/21113%
Not applicable45%
Phase 145%
Phase 2/322%
Observational11%
Early Phase 111%

Clinical trials of Cadonilimab

87 trials

Study	Phase	Status	Lead sponsor	Registers
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection NCT05489289 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma	Phase 3	Recruiting	Akeso	China
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC NCT05941741 · ClinicalTrials.gov ↗ · Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy	Phase 3	Recruiting	Sun Yat-sen University	China
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma NCT06341335 · ClinicalTrials.gov ↗ · Gastric and Gastroesophageal Junction Adenocarcinoma	Phase 3	Recruiting	Akeso	China
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma NCT06371157 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma	Phase 3	Recruiting	Akeso	China
Efficacy and Safety of AK104 Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer NCT06542549 · ClinicalTrials.gov ↗ · Advanced Ovarian Cancer, AK104(PD-1/CTLA-4 Bispecial Antibody), Chemotherapy	Phase 3	Recruiting	Anhui Provincial Hospital	China
Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer NCT06566755 · ClinicalTrials.gov ↗ · Colorectal Cancer	Phase 3	Recruiting	Caigang Liu	China
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC NCT06617416 · ClinicalTrials.gov ↗ · NSCLC (Non-small Cell Lung Cancer)	Phase 3	Recruiting	Akeso	China
A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma NCT07023315 · ClinicalTrials.gov ↗ · Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma	Phase 3	Recruiting	Akeso	China
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer NCT07412613 · ClinicalTrials.gov ↗ · Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer	Phase 3	Recruiting	Akeso	China
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma NCT07700979 · Gastric / Gastroesophageal Junction Adenocarcinoma	Phase 3	Recruiting	Akeso	USA, China, Germany, Poland
FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) NCT07815834 · ClinicalTrials.gov ↗ · Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer, Second-line Treatment	Phase 3	Recruiting	Fudan University	China
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy NCT06221748 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma	Phase 2/3	Recruiting	RemeGen Co., Ltd	China
A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) NCT06241599 · ClinicalTrials.gov ↗ · Recurrent or Metastatic Nasopharyngeal Carcinoma	Phase 2/3	Recruiting	Sun Yat-sen University	China
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer NCT05377658 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer	Phase 2	Recruiting	Henan Cancer Hospital	China
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer NCT05571644 · ClinicalTrials.gov ↗ · Colorectal Cancer	Phase 2	Recruiting	Sun Yat-sen University	China
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer NCT05817214 · ClinicalTrials.gov ↗ · Cervical Cancer	Phase 2	Recruiting	Zhongnan Hospital	China
A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer NCT05859750 · ClinicalTrials.gov ↗ · Pancreatic Cancer	Phase 2	Recruiting	Akeso	China
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma NCT05960955 · ClinicalTrials.gov ↗ · Resectable Gastric or Gastroesophageal Junction Adenocarcinoma	Phase 2	Recruiting	Akeso	China
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing NCT06145308 · ClinicalTrials.gov ↗ · Salivary Gland Carcinoma, Precision Therapy	Phase 2	Recruiting	Peking Union Medical College	China
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC NCT06168786 · Colorectal Cancer	Phase 2	Recruiting	Huazhong University of Science and Technology	China
HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma NCT06187961 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma Non-resectable	Phase 2	Recruiting	Tongji Hospital	China
AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer NCT06196697 · ClinicalTrials.gov ↗ · Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma	Phase 2	Recruiting	Harbin Medical University	China
Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery NCT06209294 · ClinicalTrials.gov ↗ · Neoadjuvant Immunotherapy, Cervical Cancer, Fertility-sparing Surgery	Phase 2	Recruiting	Xiaohua Wu	China
Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma NCT06215651 · ClinicalTrials.gov ↗ · Cadonilimab and Lenvatinib	Phase 2	Recruiting	Peking Union Medical College Hospital	China
Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer NCT06218810 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer, Microsatellite Stable Colorectal Carcinoma, RAS Mutation	Phase 2	Recruiting	Fudan University	China
A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib NCT06280105 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma	Phase 2	Recruiting	Meng Chao Hepatobiliary Hospital of Fujian Medical University	China
Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer NCT06289751 · ClinicalTrials.gov ↗ · Cervical Cancer, Neoadjuvant Chemoimmunotherapy, Radical Hysterectomy	Phase 2	Recruiting	Tongji Hospital	China
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma NCT06356688 · ClinicalTrials.gov ↗ · Locally Advanced Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy	Phase 2	Recruiting	Sun Jing	China
A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma NCT06367075 · ClinicalTrials.gov ↗ · Advanced Soft-tissue Sarcoma	Phase 2	Recruiting	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	China
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer NCT06367088 · ClinicalTrials.gov ↗ · Triple-negative Breast Cancer, Cadonilimab	Phase 2	Recruiting	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	China
SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC) NCT06401005 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 2	Recruiting	Hubei Cancer Hospital	China
NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC NCT06405490 · ClinicalTrials.gov ↗ · Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin	Phase 2	Recruiting	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	China
Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma NCT06406634 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma	Phase 2	Recruiting	Hunan Cancer Hospital	China
A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma NCT06444009 · ClinicalTrials.gov ↗ · Head and Neck Squamous Cell Carcinoma	Phase 2	Recruiting	Lei Liu	China
A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy NCT06467500 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer	Phase 2	Recruiting	Xin-Hua Xu	China
AK104 and Low-dose Radiation in Recurrent/Metastatic HNSCC After Failure of First-line Systemic Therapy NCT06494995 · ClinicalTrials.gov ↗ · Head and Neck Squamous Cell Carcinoma	Phase 2	Recruiting	Fudan University	China
Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma NCT06532539 · ClinicalTrials.gov ↗ · Endometrial Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis	Phase 2	Recruiting	Shandong Cancer Hospital and Institute	China
Neoadjuvant/Adjuvant Cadonilimab Plus Chemotherapy in Patients With Resectable PD-L1 Negative NSCLC NCT06532591 · ClinicalTrials.gov ↗ · NSCLC	Phase 2	Recruiting	Sichuan Cancer Hospital and Research Institute	China
Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer NCT06532617 · ClinicalTrials.gov ↗ · Pancreatic Neoplasms	Phase 2	Recruiting	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	China
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer NCT06560112 · ClinicalTrials.gov ↗ · Recurrent Ovarian Cancer	Phase 2	Recruiting	Akeso	China
IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial NCT06654011 · ClinicalTrials.gov ↗ · Cervical Adenocarcinoma, Gastric-type Endocervical Adenocarcinoma	Phase 2	Recruiting	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	China
Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases NCT06702826 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer, Brain Metastases, Stereotactic Radiation	Phase 2	Recruiting	Rongrong Zhou	China
Phase II Study of Ivonescimab and Cadonilimab in Combination with Chemotherapy in Patients with ES-SCLC NCT06769971 · ClinicalTrials.gov ↗ · Small Cell Lung Cancer	Phase 2	Recruiting	Sichuan University	China
Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC NCT07003022 · ClinicalTrials.gov ↗ · Colo-rectal Cancer, MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers	Phase 2	Recruiting	Fudan University	China
A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. NCT07052253 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma (HCC)	Phase 2	Recruiting	Akeso	China
Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer NCT07104149 · ClinicalTrials.gov ↗ · Female, Age ≥ 18 Years Old, No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy, ECOG Score of 0-1	Phase 2	Recruiting	The First Affiliated Hospital of Zhengzhou University	China
A Study of Ivonescimab in First-Line ES-SCLC NCT07245446 · ClinicalTrials.gov ↗ · Extensive-stage Small Cell Lung Cancer (ES-SCLC)	Phase 2	Recruiting	Akeso	China
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) NCT07263919 · ClinicalTrials.gov ↗ · Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma	Phase 2	Recruiting	Akeso	China
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma NCT04982276 · ClinicalTrials.gov ↗ · Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma	Phase 1/2	Recruiting	Akeso	China
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors NCT05142423 · ClinicalTrials.gov ↗ · Advanced Solid Tumor	Phase 1/2	Recruiting	Akeso	China
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. NCT05944224 · Advanced Solid Tumors	Phase 1/2	Recruiting	Shanghai Pharmaceuticals Holding Co., Ltd	China
A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC) NCT06530251 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma	Phase 1/2	Recruiting	Akeso	China
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients NCT06650332 · ClinicalTrials.gov ↗ · Metastatic HER2 Positive Gastroesophageal Junction Cancer	Phase 1/2	Recruiting	Zhejiang Cancer Hospital	China
Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer NCT06140589 · ClinicalTrials.gov ↗ · Cervical Cancer	Observational	Recruiting	Fujian Cancer Hospital	China
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases NCT06265350 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma, Liver Cancer Stage IV, Pulmonary Metastases	Not applicable	Recruiting	Sun Yat-sen University	China
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC NCT06551207 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer	Not applicable	Recruiting	Liu Huang	China
A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer NCT05990127 · ClinicalTrials.gov ↗ · Locally Advanced or Metastatic NSCLC	Phase 3	Not yet open	Akeso	China
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma NCT06196775 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma	Phase 2	Not yet open	Harbin Medical University	China
Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer NCT06202313 · ClinicalTrials.gov ↗ · Triple Negative Breast Cancer	Phase 2	Not yet open	Shengjing Hospital	China
Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial NCT06310473 · ClinicalTrials.gov ↗ · Gastric Cancer, Esophagogastric Junction Cancer	Phase 2	Not yet open	Nanfang Hospital, Southern Medical University	China
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer NCT06492317 · ClinicalTrials.gov ↗ · HER2-positive Gastric Cancer	Phase 2	Not yet open	The First Affiliated Hospital of Zhengzhou University	China
Cadonilimab Combined With Anlotinib Followed by Radiotherapy in Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (CAR-RMEC) NCT06681285 · ClinicalTrials.gov ↗ · Esophageal Carcinoma	Phase 2	Not yet open	Hebei Medical University Fourth Hospital	China
A Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab for Advanced Renal Cancer NCT07877194 · ClinicalTrials.gov ↗ · Renal Cell Carcinoma, Clear Cell	Phase 2	Not yet open	Summit Therapeutics	USA, China
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC NCT06913218 · ClinicalTrials.gov ↗ · Pancreas Cancer, Pancreas Cancer, Duct Cell Adenocarcinoma	Phase 1	Not yet open	Akeso	China
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations NCT07619001 · ClinicalTrials.gov ↗ · Healthy Male Adults Participants	Phase 1	Not yet open	Akeso	China
ctDNA-guided First-line Immuno-de-escalation Therapy for IVB-stage and Recurrent Cervical Cancer NCT06878196 · ClinicalTrials.gov ↗ · Uterine Cervical Neoplasm	Not applicable	Not yet open	Obstetrics & Gynecology Hospital of Fudan University	China
Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients - Pilot Study NCT07908147 · ClinicalTrials.gov ↗ · IDH Wildtype Glioblastoma, Glioblastoma (GBM)	Early Phase 1	Not yet open	Olivia Newton-John Cancer Research Institute	Australia
A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma NCT06424626 · ClinicalTrials.gov ↗ · Melanoma, Mucosal Melanoma, Metastatic Melanoma	Phase 1	By invitation	Peking University Cancer Hospital & Institute	China
Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma NCT06715501 · ClinicalTrials.gov ↗ · Locally Advanced Esophageal Squamous Cell Carcinoma, II-IIIB Stages	Not applicable	By invitation	First Affiliated Hospital of Ningbo University	China
A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer NCT04982237 · ClinicalTrials.gov ↗ · Cervical Cancer	Phase 3	Active, closed	Akeso	China
A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer NCT05235516 · ClinicalTrials.gov ↗ · Locally Advanced Cervical Carcinoma	Phase 3	Active, closed	Akeso	China
Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE) NCT05587374 · ClinicalTrials.gov ↗ · Nasopharyngeal Carcinoma, Nasopharyngeal Cancer	Phase 3	Active, closed	Sun Yat-sen University	China
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma NCT04556253 · ClinicalTrials.gov ↗ · MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer	Phase 2	Active, closed	Peking University	China
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC NCT05319431 · ClinicalTrials.gov ↗ · Unresectable, Non-metastatic Hepatocellular Carcinoma	Phase 2	Active, closed	Akeso	China
Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer NCT05824481 · ClinicalTrials.gov ↗ · Endometrial Cancer, Endometrial Adenocarcinoma	Phase 2	Active, closed	Sun Yat-sen University	China
Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative NCT06001151 · ClinicalTrials.gov ↗ · Carcinoma, Non-Small-Cell Lung	Phase 2	Active, closed	Qian Chu	China
Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006) NCT06143748 · ClinicalTrials.gov ↗ · Esophagus Cancer	Phase 2	Active, closed	Sun Yat-sen University	China
Cadonilimab(AK104) Plus Concurrent Chemoradiotherapy in Patients With Locally Advanced, Unresectable, Stage III NSCLC NCT06448910 · ClinicalTrials.gov ↗ · NSCLC, Locally Advanced Lung Carcinoma	Phase 2	Active, closed	Fudan University	China
Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer NCT06511726 · Cervical Cancer	Phase 2	Active, closed	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	China
Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer NCT07635290 · ClinicalTrials.gov ↗ · Previously Treated, Advanced, Biliary Tract Cancers	Phase 2	Active, closed	West China Hospital	China
Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer NCT05426005 · ClinicalTrials.gov ↗ · Colorectal Cancer Stage IV, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H)	Phase 1/2	Active, closed	Sun Yat-sen University	China
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma NCT05808608 · ClinicalTrials.gov ↗ · Renal Cell Carcinoma, First-line Treatment, Non Clear Cell Renal Cell Carcinoma	Phase 1/2	Active, closed	Hao Zeng	China
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer NCT05904379 · ClinicalTrials.gov ↗ · Advanced Non-small-cell Lung Cancer	Phase 1/2	Active, closed	Akeso	China
Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC NCT06477523 · ClinicalTrials.gov ↗ · SCLC, Extensive Stage	Phase 1/2	Active, closed	Sichuan University	China
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis NCT06762080 · ClinicalTrials.gov ↗ · Leptomeningeal Metastasis	Phase 1/2	Active, closed	Guangzhou Medical University	China
SBRT-LDRT-Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases NCT06940921 · ClinicalTrials.gov ↗ · Advanced Gastric Cancer, Advanced Colorectal Cancer, Advanced Ovarian Cancer	Phase 1/2	Active, closed	Zhang Tao	China
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular Carcinoma NCT05644379 · ClinicalTrials.gov ↗ · Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy	Phase 1	Active, closed	Tianjin Medical University Cancer Institute and Hospital	China

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.

Conditions studied with Cadonilimab

118 conditions

Hepatocellular Carcinoma7 Cervical Cancer6Cadonilimab4Colorectal Cancer3 Head and Neck Squamous Cell Carcinoma2 Gastric Cancer2 Nasopharyngeal Carcinoma2 NSCLC2Locally Advanced Esophageal Squamous Cell Carcinoma2Chemotherapy2 Metastatic Colorectal Cancer2 Gastroesophageal Junction Adenocarcinoma2

All 118 conditions

Condition (as registered)	Trials
Hepatocellular Carcinoma	7
Cervical Cancer	6
Cadonilimab	4
Colorectal Cancer	3
Head and Neck Squamous Cell Carcinoma	2
Gastric Cancer	2
Nasopharyngeal Carcinoma	2
NSCLC	2
Locally Advanced Esophageal Squamous Cell Carcinoma	2
Chemotherapy	2
Metastatic Colorectal Cancer	2
Gastroesophageal Junction Adenocarcinoma	2
Non-small Cell Lung Cancer	2
Advanced Ovarian Cancer	2
Gastric / Gastroesophageal Junction Adenocarcinoma	1
Renal Cell Carcinoma, Clear Cell	1
Leptomeningeal Metastasis	1
Esophagogastric Junction Cancer	1
Salivary Gland Carcinoma	1
Precision Therapy	1
HER2-positive Gastric Cancer	1
Uterine Cervical Neoplasm	1
Nasopharyngeal Cancer	1
Locally Advanced Lung Carcinoma	1
SCLC, Extensive Stage	1
II-IIIB Stages	1
Previously Treated, Advanced	1
Biliary Tract Cancers	1
Female, Age ≥ 18 Years Old	1
No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy	1
ECOG Score of 0-1	1
Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion	1
Esophagus Cancer	1
Endometrial Neoplasms	1
Neoplasm Recurrence, Local	1
Neoplasm Metastasis	1
Endometrial Cancer	1
Endometrial Adenocarcinoma	1
Triple-negative Breast Cancer	1
Immune Checkpoint Inhibitor	1
Radiotherapy	1
Resectable Colon Cancer	1
MSI-H/dMMR Colorectal Cancer	1
Carcinoma, Non-Small-Cell Lung	1
Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma	1
Liver Cancer Stage IV	1
Pulmonary Metastases	1
Gastric and Gastroesophageal Junction Adenocarcinoma	1
Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma	1
Resectable Gastric or Gastroesophageal Junction Adenocarcinoma	1
Pancreas Cancer	1
Pancreas Cancer, Duct Cell Adenocarcinoma	1
Recurrent Ovarian Cancer	1
Advanced Solid Tumors	1
Nanoliposomal Irinotecan	1
Oxaliplatin	1
Capecitabine	1
Microsatellite Stable Colorectal Carcinoma	1
RAS Mutation	1
Gastric Adenocarcinoma	1
Neoadjuvant Chemoimmunotherapy	1
Radical Hysterectomy	1
Extrafascial Hysterectomy	1
Pancreatic Neoplasms	1
Non Small Cell Lung Cancer	1
Brain Metastases	1
Stereotactic Radiation	1
Immunotherapy	1
Cervical Adenocarcinoma	1
Gastric-type Endocervical Adenocarcinoma	1
Metastatic HER2 Positive Gastroesophageal Junction Cancer	1
NSCLC (Non-small Cell Lung Cancer)	1
Triple Negative Breast Cancer	1
Breast Cancer	1
Colon Rectal Cancer Adenocarcinoma	1
Peritoneal (Metastatic) Cancer	1
Second-line Treatment	1
Radiation Therapy	1
Neoadjuvant Therapy	1
Small Cell Lung Cancer	1
Advanced Gastric Cancer	1
Advanced Colorectal Cancer	1
Peritoneal Metastasis	1
Advanced Soft-tissue Sarcoma	1
Colorectal Cancer Stage IV	1
Mismatch Repair-deficient (dMMR)	1
Microsatellite Instability-high (MSI-H)	1
Esophageal Carcinoma	1
Hepatocellular Carcinoma Non-resectable	1
Colo-rectal Cancer	1
MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers	1
Extensive-stage Small Cell Lung Cancer (ES-SCLC)	1
Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy	1
IDH Wildtype Glioblastoma	1
Glioblastoma (GBM)	1
Advanced Solid Tumor	1
Locally Advanced Cervical Carcinoma	1
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer	1
AK104(PD-1/CTLA-4 Bispecial Antibody)	1
Efficacy	1
Advanced Non-small-cell Lung Cancer	1
Pancreatic Cancer	1
Recurrent or Metastatic Nasopharyngeal Carcinoma	1
Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma	1
Cadonilimab and Lenvatinib	1
Healthy Male Adults Participants	1
Locally Advanced or Metastatic NSCLC	1
Renal Cell Carcinoma	1
First-line Treatment	1
Non Clear Cell Renal Cell Carcinoma	1
Sarcomatoid Renal Cell Carcinoma	1
Unresectable, Non-metastatic Hepatocellular Carcinoma	1
Hepatocellular Carcinoma (HCC)	1
Melanoma	1
Mucosal Melanoma	1
Metastatic Melanoma	1
Neoadjuvant Immunotherapy	1
Fertility-sparing Surgery	1

By country register

Register	Trials	Recruiting
Clinical trials in China	86	56
Clinical trials in USA	2	1
Clinical trials in Germany	1	1
Clinical trials in Poland	1	1
Clinical trials in Australia	1	0

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

Related compounds

Questions about Cadonilimab trials

How many clinical trials are testing Cadonilimab?

87 current trials in our China, USA, Germany, Poland and Australia registers name Cadonilimab (also registered as AK104) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Cadonilimab trials recruiting patients?

Yes. 56 of the 87 trials are recruiting: 56 with sites in China, 1 with sites in USA, 1 with sites in Germany and 1 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Cadonilimab clinical trials?

Akeso (23), Sun Yat-sen University (8), Fudan University (5) and Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (3), among 48 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 Cadonilimab works or whether it is effective, and it is not medical advice.

How this page is built

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

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Cadonilimab (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

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 — 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 — we correct promptly and log it.