10 unknown, 7 completed, 6 not yet recruiting, 6 recruiting. 34 Phase 2, 8 Phase 1, 2 Phase 3.
Follow donafenib: new trials by email Literature Review of donafenib trials Research Report on donafenib
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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab - Biliary Tract Carcinoma | Phase 2 | Recruiting | Fudan University | 93 | 2022-10-18 | 2026-01-14 |
| HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC HAIC(FOLFOX), Oxaliplatin, Leucovorin - Hepatocellular Carcinoma | Phase 2 | Unknown | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 93 | 2022-09-01 | 2022-08-18 |
| Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma Donafenib plus Sintilimab in combination with transarterial chemoembolisation - Unresectable Hepatocellular Carcinoma | Phase 2 | Active not recruiting | Nanfang Hospital, Southern Medical University | 48 | 2022-08-18 | 2026-06-01 |
| HAIC Combined With Donafenib and Sintilimab for Unresectable ICC HAIC combined with donafenib and sintilimab - Cholangiocarcinoma | Phase 2 | Completed | Zhongda Hospital | 25 | 2022-06-13 | 2026-01-06 |
| HAIC Combined With Toripalimab and Donafenib for Advanced BTC HAIC, Gemcitabine, Oxaliplatin - Biliary Tract Adenocarcinoma | Phase 2 | Unknown | Lu Wang, MD, PhD | 70 | 2022-03-01 | 2022-10-18 |
| Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery Hepatic arterial infusion chemotherapy, Folfox Protocol, Donafenib - Carcinoma, Carcinoma, Hepatocellular | Phase 2 | Completed | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 30 | 2021-12-27 | 2026-06-30 |
| Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial. HAIC, TACE, FOLFOX - Hepatocellular Carcinoma | Phase 2 / Phase 3 | Terminated | Peking University | 18 | 2021-12-24 | 2025-12-18 |
Showing 20 of 34. Sign in to see all of them.
Carcinoma, Hepatocellular (15) · Cholangiocarcinoma (2) · Carcinoma (1) · Cirrhosis, Familial, with Pulmonary Hypertension (1) · Colorectal Neoplasms (1) · Diabetes Mellitus (1) · Digestive System Neoplasms (1) · Esophageal Neoplasms (1) · Liver Neoplasms (1) · Nasopharyngeal Carcinoma (1) · Pancreatic Neoplasms (1) · Stomach Neoplasms (1)
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (9) · Fudan University (4) · Tianjin Medical University Cancer Institute and Hospital (4) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (2) · Sun Yat-sen University (2) · Anhui Provincial Hospital (1) · Beijing Tsinghua Chang Gung Hospital (1) · Fei Gao (1) · Haibo Shao (1) · Henan Cancer Hospital (1) · Lu Wang, MD, PhD (1) · Nanfang Hospital, Southern Medical University (1) · Peking Union Medical College Hospital (1) · Peking University (1) · Shanghai Zhongshan Hospital (1)
China (28)
Feng Bi, Doctor (2) · Bao Rui, Doctor (1) · Fei Gao, M.D.，Ph.D. (1) · Feng Bi, MD (1) · Gao-Jun Teng (1) · Haibo Shao (1) · Jason Wu (1) · Jian Zhou, M.D., Ph.D. (1) · Jianming Xu, Doctor (1) · Jinxue Zhou (1) · Jinzhang Chen (1) · Lei Zhang, PHD (1) · Lianxin Liu (1) · Lu Wang, M.D. (1) · Shukui Qin, MD (1)
PMID 32907500, PMID 33538338, PMID 39924483, PMID 40304938, PMID 40475000, PMID 40812353, PMID 41163129