๐Ÿ‡ฎ๐Ÿ‡ชIreland
16ยฐC Partly Cloudy ยท Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Priya Life Science Compound trial record
Trackers Drugs Trial finder
Compound · clinical trials

Envafolimab clinical trials

Also listed in trial records as Anti-PD-L1 Monoclonal Antibody, PD-L1 inhibitor, KN035
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 21 trials in our China register that name Envafolimab as an intervention. Synced 25 Sep 2026
21Current trials
14Recruiting now
16Lead sponsors
1Country register
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

Envafolimab is named as an intervention in 21 current clinical trials in our China register. 14 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is 3D Medicines (Sichuan) Co., Ltd (4). The most-studied condition is Non-small Cell Lung Cancer.

Trials by status

  • Recruiting1467%
  • Not yet open629%
  • Active, closed15%

Trials by phase

  • Phase 21571%
  • Phase 1/2210%
  • Phase 3210%
  • Phase 2/315%
  • Observational15%
01

Clinical trials of Envafolimab

21 trials
StudyPhaseStatusLead sponsorRegisters
Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma
NCT05752136 · ClinicalTrials.gov ↗ · Rectal Cancer
Phase 3 Recruiting Sir Run Run Shaw Hospital China
KN035 for dMMR/MSI-H Advanced Solid Tumors
NCT03667170 · ClinicalTrials.gov ↗ · Solid Tumor
Phase 2 Recruiting 3D Medicines (Sichuan) Co., Ltd. China
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
NCT04891198 · ClinicalTrials.gov ↗ · Solid Tumor
Phase 2 Recruiting 3D Medicines (Sichuan) Co., Ltd. China
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
NCT05397769 · ClinicalTrials.gov ↗ · Locally Advanced Nasopharyngeal Carcinoma, Envafolimab, Induction Chemotherapy
Phase 2 Recruiting Sun Yat-sen University China
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer
NCT05914389 · ClinicalTrials.gov ↗ · Colon Neoplasm
Phase 2 Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine China
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
NCT06498622 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma
Phase 2 Recruiting Anhui Provincial Hospital China
Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer
NCT06734182 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer
Phase 2 Recruiting Guangdong Provincial People's Hospital China
Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer
NCT06791083 · ClinicalTrials.gov ↗ · Gastric Cancer
Phase 2 Recruiting First Affiliated Hospital of Fujian Medical University China
Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma
NCT07243626 · ClinicalTrials.gov ↗ · Soft Tissue Sarcoma
Phase 2 Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine China
HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC
NCT07364305 · ClinicalTrials.gov ↗ · ICC, Advanced Cancer
Phase 2 Recruiting Eastern Hepatobiliary Surgery Hospital China
Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment
NCT07559864 · ClinicalTrials.gov ↗ · GIST - Gastrointestinal Stromal Tumor, KIT Gene Mutation
Phase 2 Recruiting Jian Li China
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
NCT05024214 · ClinicalTrials.gov ↗ · Solid Tumors, Non-small Cell Lung Cancer, Renal Cell Carcinoma
Phase 1/2 Recruiting 3D Medicines (Sichuan) Co., Ltd. China
RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure
NCT06663007 · ClinicalTrials.gov ↗ · Prostate Cancer, CDK12 Gene Mutation
Phase 1/2 Recruiting Tianjin Medical University Second Hospital China
Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy
NCT06869239 · ClinicalTrials.gov ↗ · Limited-stage Small Cell Lung Cancer (LS-SCLC)
Observational Recruiting Peking University Cancer Hospital & Institute China
A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-ฮฒand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)
NCT06959693 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer (CRC)
Phase 2/3 Not yet open Sun Yat-sen University China
Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer
NCT05969847 · ClinicalTrials.gov ↗ · Rectal Cancer
Phase 2 Not yet open ๆฑ ็•” China
A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment
NCT06772233 · ClinicalTrials.gov ↗ · Metastatic Gastrointestinal Stromal Tumors (GIST)
Phase 2 Not yet open Peking University China
Cetuximab ฮฒ Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors
NCT07327411 · ClinicalTrials.gov ↗ · Advanced Refractory Solid Tumors
Phase 2 Not yet open Second Affiliated Hospital of Soochow University China
A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.
NCT07729033 · Advanced Biliary Tract Cancers
Phase 2 Not yet open Tianjin Medical University Cancer Institute and Hospital China
SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC
NCT07818304 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer, Lung Neoplasms
Phase 2 Not yet open The First People's Hospital of Lianyungang China
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
NCT03478488 · ClinicalTrials.gov ↗ · Biliary Tract Neoplasms
Phase 3 Active, closed 3D Medicines (Sichuan) Co., Ltd. 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.

02

Conditions studied with Envafolimab

27 conditions
Non-small Cell Lung Cancer2Rectal Cancer2Hepatocellular Carcinoma2Solid Tumor2Advanced Biliary Tract Cancers1Colon Neoplasm1Non Small Cell Lung Cancer1Lung Neoplasms1Prostate Cancer1CDK12 Gene Mutation1Solid Tumors1Renal Cell Carcinoma1
All 27 conditions
Condition (as registered)Trials
Non-small Cell Lung Cancer2
Rectal Cancer2
Hepatocellular Carcinoma2
Solid Tumor2
Advanced Biliary Tract Cancers1
Colon Neoplasm1
Non Small Cell Lung Cancer1
Lung Neoplasms1
Prostate Cancer1
CDK12 Gene Mutation1
Solid Tumors1
Renal Cell Carcinoma1
Metastatic Gastrointestinal Stromal Tumors (GIST)1
Gastric Cancer1
GIST - Gastrointestinal Stromal Tumor1
KIT Gene Mutation1
Soft Tissue Sarcoma1
Metastatic Colorectal Cancer (CRC)1
Advanced Refractory Solid Tumors1
Locally Advanced Nasopharyngeal Carcinoma1
Envafolimab1
Induction Chemotherapy1
PD-L11
Limited-stage Small Cell Lung Cancer (LS-SCLC)1
ICC1
Advanced Cancer1
Biliary Tract Neoplasms1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
3D Medicines (Sichuan) Co., Ltd.4
Second Affiliated Hospital, Zhejiang University, School of Medicine2
Sun Yat-sen University2
Tianjin Medical University Cancer Institute and Hospital1
Guangdong Provincial People's Hospital1
The First People's Hospital of Lianyungang1
Tianjin Medical University Second Hospital1
ๆฑ ็•”1
Peking University1
First Affiliated Hospital of Fujian Medical University1
Jian Li1
Sir Run Run Shaw Hospital1
Anhui Provincial Hospital1
Second Affiliated Hospital of Soochow University1
Peking University Cancer Hospital & Institute1

+ 1 more sponsors in the trial list above.

04

By country register

RegisterTrialsRecruiting
Clinical trials in China2114

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

05

Related compounds

06

Questions about Envafolimab trials

How many clinical trials are testing Envafolimab?

21 current trials in our China register name Envafolimab (also registered as Anti-PD-L1 Monoclonal Antibody) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Envafolimab trials recruiting patients?

Yes. 14 of the 21 trials are recruiting: 14 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Envafolimab clinical trials?

3D Medicines (Sichuan) Co., Ltd (4), Second Affiliated Hospital, Zhejiang University, School of Medicine (2), Sun Yat-sen University (2) and Tianjin Medical University Cancer Institute and Hospital (1), among 16 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 Envafolimab 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 โ€” it is not written from memory, and nothing here describes how Envafolimab 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 Envafolimab (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 25 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.