132 completed, 47 unknown, 38 recruiting, 33 terminated. 178 Phase 2, 75 Phase 1, 37 Phase 3, 9 Not applicable, 4 Phase 4.
Follow regorafenib: new trials by email Literature Review of regorafenib trials Research Report on regorafenib
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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced/Metastatic Solid Tumors SYS6088, Regorafenib, Ivonescimab - Advanced/Metastatic Solid Tumors | Phase 1 / Phase 2 | Not yet recruiting | CSPC Megalith Biopharmaceutical Co.,Ltd. | 140 | 2026-10-03 | 2026-10-05 |
| A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer SYS6090 (Fixed Dose Level A) + bevacizumab, SYS6090 (Fixed Dose Level B ) + bevacizumab, SYS6090 RP2D + bevacizumab +mFOLFOX6 - Unresectable Advanced or Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Not yet recruiting | CSPC Megalith Biopharmaceutical Co.,Ltd. | 260 | 2026-08-30 | 2026-08-06 |
| Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma Regorafenib, TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization - Unresectable Hepatocellular Carcinoma, Hepatocellular Carcinoma | Phase 2 | Withdrawn | University of Miami | 2026-08-01 | 2026-06-15 | |
| A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan BL-M07D1, Regorafenib, Fruquintinib - Colorectal Cancer | Phase 3 | Not yet recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 130 | 2026-08-01 | 2026-08-27 |
| IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer IBI363 + bevacizumab, Investigator's choice of therapy - Colorectal Cancer | Phase 3 | Recruiting | Innovent Biologics (Suzhou) Co. Ltd. | 550 | 2026-07-31 | 2026-08-10 |
| Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors YMN101, YMN102, YMN103 - Malignant Tumor | Phase 1 | Recruiting | West China Hospital | 54 | 2026-06-05 | 2026-06-09 |
| Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) NB003, regorafenib - GIST - Gastrointestinal Stromal Tumor, Advanced | Phase 2 / Phase 3 | Recruiting | Ningbo Newbay Technology Development Co., Ltd | 255 | 2026-05-11 | 2026-06-10 |
| Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) Lenvatinib, regorafenib - Hepatocellular Carcinoma (HCC) | Phase 2 | Not yet recruiting | Asan Medical Center | 146 | 2026-04-01 | 2026-05-27 |
| Regorafenib After Treatment Failure of First Line Immune Checkpoint Inhibitor Treatment in Advanced Hepatocellular Carcinoma Patients Regorafenib (BAY 73-4506) - Carcinoma, Hepatocellular, Hepatic Insufficien | Phase 2 | Not yet recruiting | Ju Hyun Shim | 20 | 2026-03-15 | 2026-04-07 |
| Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial Regorafenib (BAY 73-4506) - Carcinoma, Hepatocellular, Lenvatinib | Phase 2 | Not yet recruiting | Ju Hyun Shim | 24 | 2026-03-15 | 2026-04-07 |
| A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer BioTTT001 hepatic artery infusion, toripalimab, regorafenib - Colorectal Cancer Metastatic | Phase 1 | Not yet recruiting | China Medical University, China | 60 | 2026-03-01 | 2026-01-07 |
| A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma SH006, Bevacizumab, Oxaliplatin injection - Hepatocellular Carcinoma (HCC) | Phase 2 / Phase 3 | Not yet recruiting | Nanjing Sanhome Pharmaceutical, Co., Ltd. | 120 | 2026-03-01 | 2026-02-09 |
| A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs TQB2102 Injection, Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets - HER2 IHC3+ Advanced Colorectal Cancer | Phase 3 | Not yet recruiting | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | 142 | 2026-03-01 | 2026-03-19 |
| Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial] Regorafenib (CT), Lorigerlimab - Colorectal Cancer, Regorafenib | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 16 | 2026-02-11 | 2026-08-27 |
| JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan JSKN003, Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib. - HER2-positive Colorectal Cancer | Phase 3 | Not yet recruiting | Shanghai JMT-Bio Inc. | 123 | 2026-02-06 | 2026-02-03 |
| A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma Lenvatinib, Regorafenib (BAY 73-4506), Tislelizumab+TKI - Hepato Cellular Carcinoma (HCC) | Phase 2 | Recruiting | Fudan University | 350 | 2026-01-19 | 2026-04-21 |
| Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma AST-3424, Regorafenib Tablets - HCC - Hepatocellular Carcinoma | Phase 2 | Recruiting | Zhejiang Hisun Pharmaceutical Co. Ltd. | 75 | 2026-01-01 | 2025-12-30 |
| Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer. DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection - DC-CIK Treatment, Regorafenib | Early Phase 1 | Recruiting | JIANG LONGWEI | 14 | 2025-11-19 | 2026-01-15 |
| Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration - CIC-Rearranged Sarcoma, Metastatic Ewing Sarcoma | Phase 2 / Phase 3 | Terminated | Children's Oncology Group | 2 | 2025-11-10 | 2026-10-05 |
| A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer Regorafenib, Lorigerlimab - Rectal Cancer, Rectal Cancer Recurrent | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2025-10-27 | 2026-02-25 |
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Colorectal Neoplasms (108) · Carcinoma, Hepatocellular (34) · Neoplasm Metastasis (19) · Gastrointestinal Stromal Tumors (17) · Neoplasms (17) · Colonic Neoplasms (14) · Rectal Neoplasms (12) · Liver Neoplasms (8) · Glioblastoma (7) · Sarcoma (6) · Adenocarcinoma (5) · Cholangiocarcinoma (5) · Melanoma (5) · Osteosarcoma (5) · Ovarian Neoplasms (5)
Bayer (54) · Fudan University (7) · M.D. Anderson Cancer Center (7) · Sun Yat-sen University (6) · Academic and Community Cancer Research United (5) · Asan Medical Center (5) · China Medical University, China (5) · Peking University Cancer Hospital & Institute (5) · Tianjin Medical University Cancer Institute and Hospital (5) · City of Hope Medical Center (4) · Istituto Oncologico Veneto IRCCS (4) · Memorial Sloan Kettering Cancer Center (4) · Australasian Gastro-Intestinal Trials Group (3) · Bristol-Myers Squibb (3) · Centre Hospitalier Universitaire de Besancon (3)
United States (111) · China (70) · France (48) · Italy (39) · Spain (36) · South Korea (35) · Germany (30) · Australia (25) · Canada (22) · Japan (22) · Belgium (21) · Taiwan (21) · United Kingdom (20) · Netherlands (16) · Austria (12)
Marwan G Fakih (3) · Chun-Nan Yeh, MD (2) · Funan Liu, MD (2) · Jaw-Yuan Wang, PhD (2) · Kanwal Raghav, MD (2) · Lin Shen (2) · Nick Pavlakis, Prof (2) · Suzanne George, MD (2) · Yelena Janjigian, MD (2) · Yunpeng Liu, PhD (2)
PMID 27932229, PMID 28712102, PMID 23493136, PMID 25981818, PMID 38861286, PMID 22421192, PMID 23177514, PMID 25655899, PMID 28295221, PMID 30477937, PMID 31013172, PMID 31262657, PMID 31401903, PMID 32343640, PMID 36814222, PMID 36892833, PMID 37090438, PMID 16527888, PMID 18650514, PMID 19095497, PMID 19111391, PMID 20332205, PMID 20516446, PMID 21321535, PMID 21345145, PMID 21374666, PMID 22424278, PMID 22959186, PMID 23108136, PMID 23177515, PMID 23809766, PMID 24575021, PMID 24957256, PMID 25088940, PMID 25213161, PMID 25600568, PMID 25601652, PMID 25753361, PMID 25834402, PMID 25884155, PMID 26003007, PMID 26184520, PMID 26281907, PMID 26338525, PMID 26755520, PMID 26822708, PMID 27149842, PMID 27371698, PMID 27389564, PMID 27629931
P30CA015083 (5), 2017 (4), 2018 (4), 2023 (4), 2009 (3), 2014 (3), 2016 (3), 2019 (3), P30CA033572 (3), 2008 (2), P30CA014089 (2), 2015 (1), P30CA012197 (1), P30CA016056 (1), P30CA043703 (1)