29 unknown, 17 not yet recruiting, 15 recruiting, 4 completed. 68 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 68 | Unknown 29, Not yet recruiting 17, Recruiting 15, Completed 4, Active not recruiting 2, Suspended 1 |
| Phase 1 | 3 | Recruiting 2, Unknown 1 |
| Phase 3 | 1 | Not yet recruiting 1 |
Follow envafolimab: new trials by email Literature Review of envafolimab trials Research Report on envafolimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers Envafolimab plus Gemcitabine&Cisplatin, Gemcitabine&Cisplatin - Biliary Tract Neoplasms | Phase 2 | Not yet recruiting | 3D Medicines (Sichuan) Co., Ltd. | 126 | 2027-06-01 | 2026-03-25 |
| SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC Stereotactic Radiation Therapy, Envafolimab, Endostar - Non Small Cell Lung Cancer, Lung Neoplasms | Phase 2 | Not yet recruiting | The First People's Hospital of Lianyungang | 61 | 2026-10-01 | 2026-09-14 |
| 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. Sacituzumab tirumotecan combined with envafolimab - Advanced Biliary Tract Cancers | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 28 | 2026-08-01 | 2026-07-27 |
| Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies Neoadjuvant therapy followed by surgery - Biliary Tract Cancer | Phase 2 | Not yet recruiting | Sir Run Run Shaw Hospital | 34 | 2026-05-30 | 2026-05-20 |
| Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. Envafolimab and recombinant human endostatin combined with chemoradiotherapy - Nasopharyngeal Carcinoma | Phase 2 | Recruiting | Chongqing University Cancer Hospital | 30 | 2026-02-09 | 2026-02-18 |
| Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors Hypofractionated radiotherapy, PD-L1 inhibitor, GM-CSF - Advanced Refractory Solid Tumors | Phase 2 | Not yet recruiting | Second Affiliated Hospital of Soochow University | 40 | 2025-12-27 | 2026-01-08 |
| Envafolimab Combined With Axitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma Envafolimab Injection, Axitinib Tablets - Advanced Renal Cell Carcinoma (aRCC) | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 30 | 2025-09-01 | 2025-09-08 |
| Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients Envafolimab and neoadjuvant chemotherapy - Osteosarcoma, Neoadjuvant Therapy | Phase 2 | Not yet recruiting | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | 23 | 2025-08-25 | 2025-08-27 |
| A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment regorafenib combined with envafolimab, Control Group - Metastatic Gastrointestinal Stromal Tumors (GIST) | Phase 2 | Not yet recruiting | Peking University | 100 | 2025-07-30 | 2025-07-31 |
| 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 physician-selected treatment, Regorafenib + Envafolimab - GIST - Gastrointestinal Stromal Tumor, KIT Gene Mutation | Phase 2 | Recruiting | Jian Li | 100 | 2025-07-14 | 2026-04-30 |
| A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC) Cetuxima-β, Envafolimab, mFOLFOX6 - Metastatic Colorectal Cancer (CRC) | Phase 2 / Phase 3 | Not yet recruiting | Sun Yat-sen University | 590 | 2025-06-01 | 2025-05-06 |
| Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer Envafolimab + Gemcitabine + Cisplatin + Simvastatin - Biliary Tract Cancer, Advanced Cancer | Phase 2 | Not yet recruiting | Tongji Hospital | 62 | 2025-06-01 | 2025-06-04 |
| Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS Albumin-Bound Paclitaxel, Epirubicin, Gemcitabine - Rare Tumour | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | 200 | 2025-01-01 | 2024-11-18 |
| Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin Chemotherapy （Etoposide and Carboplatin）, Immunotherapy （Envafolimab）, Trilaciclib - Lung Cancer, Small Cell | Phase 2 | Recruiting | Shanghai Chest Hospital | 52 | 2024-10-13 | 2024-11-21 |
| Local Injection and Systemic Therapy in the Treatment of NSCLC. Envafolimab, Recombinant human endostatin, recombinant human adenovirus type 5 - Non-small Cell Lung Cancer | Phase 2 | Not yet recruiting | Henan Cancer Hospital | 84 | 2024-10-08 | 2024-10-01 |
| Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma Envafolimab and Surufatinib - Unresectable Biliary Tract Carcinoma | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2024-10-01 | 2024-10-24 |
| RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure RC48, Envafolimab - Prostate Cancer, CDK12 Gene Mutation | Phase 1 / Phase 2 | Recruiting | Tianjin Medical University Second Hospital | 72 | 2024-09-24 | 2024-10-29 |
| Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab Donafenib + Envafolimab - Hepatocellular Carcinoma | Phase 2 | Recruiting | Anhui Provincial Hospital | 45 | 2024-07-20 | 2024-07-12 |
| Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer Envafolimab, Fruquintinib - Gastric Cancer | Phase 2 | Recruiting | First Affiliated Hospital of Fujian Medical University | 40 | 2024-06-20 | 2025-01-24 |
| ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC irinotecan, cetuximab, envafolimab - RAS Mutation, Metastatic Colorectal Cancer | Phase 2 | Recruiting | Beijing Hospital | 60 | 2024-03-01 | 2026-07-28 |
Showing 20 of 68. Sign in to see all of them.
Carcinoma, Non-Small-Cell Lung (8) · Colorectal Neoplasms (6) · Biliary Tract Neoplasms (5) · Colonic Neoplasms (3) · Sarcoma (3) · Carcinoma, Hepatocellular (2) · Gastrointestinal Stromal Tumors (2) · Lung Neoplasms (2) · Nasopharyngeal Carcinoma (2) · Rectal Neoplasms (2) · Carcinoma, Ovarian Epithelial (1) · Carcinoma, Renal Cell (1) · Chondrosarcoma (1) · Dermatofibrosarcoma (1) · Diabetes Mellitus, Insulin-Dependent, 12 (1)
3D Medicines (Sichuan) Co., Ltd. (5) · Sun Yat-sen University (5) · Sir Run Run Shaw Hospital (3) · Tianjin Medical University Cancer Institute and Hospital (3) · Chongqing University Cancer Hospital (2) · Peking Union Medical College Hospital (2) · The First People's Hospital of Lianyungang (2) · Tracon Pharmaceuticals Inc. (2) · Anhui Chest Hospital (1) · Anhui Provincial Cancer Hospital (1) · Anhui Provincial Hospital (1) · Ascletis Pharmaceuticals Co., Ltd. (1) · Beijing Hospital (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · Chipscreen Biosciences, Ltd. (1)
China (47) · United States (2) · United Kingdom (1)
Liangjun Zhu (2) · Lin Shen, MD (2) · Charles Theuer, MD, PhD (1) · Deping Zhao, MD,PhD (1) · Enxiao Li (1) · Hairong Liu, Doctor (1) · Hong Ren, MM (1) · Hongbo Wu, M.D. (1) · James Freddo, MD (1) · Jian Li, Dr. (1) · Jian Li, MD (1) · Jiang D Sui, Ph.D, M.D. (1) · Jun Li, MD (1) · Li Zhang (1) · Lianxin Liu (1)
PMID 34154614, PMID 22099051, PMID 38982653, PMID 39384742, PMID 40658469