32 unknown, 19 recruiting, 18 not yet recruiting, 9 completed. 68 Phase 2, 9 Phase 1, 3 Phase 3, 1 Not applicable.
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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 |
| Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program Envafolimab - Advanced Solid Tumor | Recruiting | IR INNOVATE RESEARCH PRIVATE LIMITED | 120 | 2026-08-07 | 2026-11-06 | |
| 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 |
| Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks - Potentially Resectable Hepatocellular Carcinoma | Not applicable | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 35 | 2026-07-31 | 2026-07-30 |
| 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 |
| A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients KGX101 injection, Envafolimab - Advanced or Metastatic Solid Tumors | Phase 1 | Recruiting | Kangabio AUSTRALIA LTD PTY | 57 | 2024-11-27 | 2026-04-24 |
| 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 |
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Carcinoma, Non-Small-Cell Lung (8) · Biliary Tract Neoplasms (6) · Colorectal Neoplasms (6) · Colonic Neoplasms (3) · Rectal Neoplasms (3) · Sarcoma (3) · Carcinoma, Hepatocellular (2) · Carcinoma, Ovarian Epithelial (2) · Gastrointestinal Stromal Tumors (2) · Lung Neoplasms (2) · Nasopharyngeal Carcinoma (2) · Uterine Cervical Neoplasms (2) · Carcinoma, Renal Cell (1) · Cholangiocarcinoma (1) · Chondrosarcoma (1)
3D Medicines (Sichuan) Co., Ltd. (10) · Sun Yat-sen University (5) · Sir Run Run Shaw Hospital (4) · Tianjin Medical University Cancer Institute and Hospital (4) · Chongqing University Cancer Hospital (2) · Fudan University (2) · Kangabio AUSTRALIA LTD PTY (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)
China (54) · United States (3) · Australia (1) · Japan (1) · Kenya (1) · Mauritius (1) · Philippines (1) · United Kingdom (1)
Liangjun Zhu (2) · Lin Shen, MD (2) · Charles Theuer, MD, PhD (1) · David Liu, M.D. (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 Guo (1)
PMID 38982653, PMID 34154614, PMID 22099051, PMID 33973293, PMID 35932387, PMID 39384742, PMID 40658469