17 unknown, 9 completed, 9 not yet recruiting, 9 recruiting. 34 Phase 2, 12 Phase 1, 4 Phase 3, 3 Not applicable, 3 Phase 4.
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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 |
|---|---|---|---|---|---|---|
| Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes Epalrestat, Donafenib + Tislelizumab, HAIC - HCC - Hepatocellular Carcinoma, Diabetes | Phase 2 | Not yet recruiting | Haibo Shao | 32 | 2026-10-01 | 2026-09-21 |
| A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion HAIC, Donafenib + lenvatinib+apatinib, Sintilimab+camrelizumab+tislelizumab - Liver Cancer | Phase 4 | Not yet recruiting | Zhai Wenlong | 40 | 2026-08-30 | 2026-08-27 |
| Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome Dapagliflozin, Donafenib, Tislelizumab - Hepatocellular Carcinoma (HCC) | Phase 2 | Not yet recruiting | Sun Yat-sen University | 44 | 2026-07-01 | 2026-07-27 |
| The DoHAICs Study Expansion Phase Donafenib, sintilimab, HAIC - HCC - Hepatocellular Carcinoma | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 90 | 2026-05-20 | 2026-05-13 |
| FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma hepatic arterial infusion chemotherapy (HAIC), Donafenib, Pucotenlimab - Intrahepatic Cholangiocarcinoma (Icc), Hepatic Arterial Infusion Chemotherapy | Phase 2 | Not yet recruiting | Sun Yat-sen University | 36 | 2026-02-01 | 2026-01-20 |
| The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study E-TACE, Donafenib - Carcinoma, Hepatocellular Carcinoma | Not yet recruiting | Xuhua Duan | 118 | 2025-10-10 | 2025-09-18 | |
| Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma Gecacitinib Combined With Donafenib and PD-1 Inhibitor - Hepatocellular Carcinoma | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 35 | 2025-09-10 | 2025-09-05 |
| HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence HAIC combined with sintilimab and donafenib, Sintilimab and Donafenib, Surgery - Hepato Cellular Carcinoma (HCC) | Phase 2 | Recruiting | Fudan University | 165 | 2025-01-01 | 2025-02-06 |
| Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk Donafenib, capecitabine - Biliary Malignant Tumors | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 70 | 2024-11-15 | 2025-01-28 |
| TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension Transjugular intrahepatic portosystemic shunt (TIPS), Donafenib - Hepatocellular Carcinoma with PVTT | Phase 2 | Recruiting | Fei Gao | 40 | 2024-10-08 | 2024-10-17 |
| Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC Thermal ablation, Donafenib - Hepatocellular Carcinoma, Microwave Ablation | Not applicable | Recruiting | Sun Yat-sen University | 108 | 2024-10-01 | 2024-12-03 |
| Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma Donafenib - Hepatocellular Carcinoma, Adjuvant Therapy | Not applicable | Recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 204 | 2024-08-28 | 2024-09-03 |
| Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy Donafenib, transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy, PD-1,PD-L1 - Unresectable Hepatocellular Carcinoma | Phase 4 | Not yet recruiting | Tongji Hospital | 32 | 2024-08-01 | 2024-07-11 |
| Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma Donafenib, Sintilimab, HAIC - Hepatocellular Carcinoma | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2024-07-30 | 2024-07-22 |
| 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 |
| A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor ZG005 Powder for Injection, Donafenib Tosilate Tablets - Solid Tumor | Phase 1 / Phase 2 | Unknown | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | 130 | 2024-05-10 | 2024-06-14 |
| A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma ZG005 Powder for Injection, Donafenib Tosilate Tablets, Bevacizumab - Advanced Hepatocellular Carcinoma | Not applicable | Unknown | Changsha Taihe Hospital | 30 | 2024-01-01 | 2024-01-31 |
| Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation Donafenib, TACE - Hepatocellular Carcinoma | Phase 2 | Unknown | Beijing Tsinghua Chang Gung Hospital | 20 | 2023-03-30 | 2023-07-13 |
| Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study transarterial therapies - Hepatocellular Carcinoma Non-resectable | Unknown | Zhujiang Hospital | 100 | 2022-12-02 | 2022-12-06 | |
| Study of Donafenib Combined With Tislelizumab in the Adjuvant Treatment of Primary HCC With High Risk of Recurrence Donafenib + Tislelizumab - Hepatocellular Carcinoma | Phase 2 | Unknown | Henan Cancer Hospital | 32 | 2022-11-01 | 2022-09-19 |
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Carcinoma, Hepatocellular (22) · Liver Neoplasms (3) · Carcinoma (2) · Cholangiocarcinoma (2) · Colorectal Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (1) · Cirrhosis, Familial, with Pulmonary Hypertension (1) · Diabetes Mellitus (1) · Digestive System Neoplasms (1) · Esophageal Neoplasms (1) · Leukemia, Myeloid, Acute (1) · Nasopharyngeal Carcinoma (1) · Pancreatic Neoplasms (1) · Recurrence (1) · Stomach Neoplasms (1)
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (13) · Fudan University (4) · Tianjin Medical University Cancer Institute and Hospital (4) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (3) · Sun Yat-sen University (3) · Anhui Provincial Hospital (2) · Shanghai Zhongshan Hospital (2) · Tongji Hospital (2) · Beijing Tsinghua Chang Gung Hospital (1) · Changsha Taihe Hospital (1) · Fei Gao (1) · First Affiliated Hospital of Zhejiang University (1) · Haibo Shao (1) · Henan Cancer Hospital (1) · Lu Wang, MD, PhD (1)
China (42)
Feng Bi, Doctor (2) · Bao Rui, Doctor (1) · Bi Feng, MD (1) · Changzhen Shang, MD (1) · Fei Gao, M.D.，Ph.D. (1) · Feng Bi, MD (1) · Feng Duan, Professor (1) · Gao-Jun Teng (1) · Haibo Shao (1) · Jason Wu (1) · Jian Zhou, M.D., Ph.D. (1) · Jianming Xu, Doctor (1) · Jianxiang Wang, Doctor (1) · Jianying Zhou, MD (1) · Jinxue Zhou (1)
PMID 39924483, PMID 32907500, PMID 33538338, PMID 40304938, PMID 40475000, PMID 40812353, PMID 41163129