28 recruiting, 28 unknown, 23 completed, 13 not yet recruiting. 64 Phase 2, 18 Phase 1, 11 Phase 3, 3 Not applicable, 3 Phase 4.
Follow Fruquintinib: new trials by email Literature Review of Fruquintinib trials Research Report on Fruquintinib
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 Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer Fruquintinib, Sintilimab, Irinotecan Hydrochloride Liposome Injection (II) - Stomach Neoplasms, Gastric Cancer | Phase 2 | Not yet recruiting | Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | 20 | 2026-10-01 | 2026-09-14 |
| A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma LBL-024 for Injection, Bevacizumab injection, Oxaliplatin injection - Metastatic Colorectal Carcinoma | Phase 1 / Phase 2 | Recruiting | Nanjing Leads Biolabs Co.,Ltd | 369 | 2026-09-28 | 2026-10-16 |
| 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 |
| A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer HDM2017, Fruquintinib - Colorectal Cancer Metastatic | Phase 1 / Phase 2 | Not yet recruiting | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | 120 | 2026-07-15 | 2026-06-02 |
| A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer Iparomlimab and Tuvonralimab (QL1706), Fruquintinib, Heterogeneous Radiotherapy - Metastatic Colorectal Cancer (CRC), mCRC | Phase 2 | Not yet recruiting | Huazhong University of Science and Technology | 60 | 2026-05-01 | 2026-03-30 |
| Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K) Fruquintinib - Colon Cancer | Phase 2 | Not yet recruiting | Korea University Anam Hospital | 88 | 2026-05-01 | 2026-04-06 |
| A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer S-531011, Fruquintinib, Pembrolizumab - Metastatic Colorectal Neoplasms, Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer | Phase 1 / Phase 2 | Not yet recruiting | National Cancer Center Hospital East | 68 | 2026-05-01 | 2026-05-18 |
| Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer Fruquintinib - Metastatic Colorectal Cancer (CRC), Antineoplastic Agents, Immunological | Not applicable | Recruiting | Federation Francophone de Cancerologie Digestive | 300 | 2026-03-10 | 2026-05-26 |
| FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer Serplulimab, Fruquintinib, mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) - Colorectal Cancer (Locally Advanced or Metastatic), Colorectal Cancer Microsatellite Stable (MSS) | Phase 4 | Not yet recruiting | Ye Xu | 42 | 2026-03-01 | 2026-03-03 |
| Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer Fruquintinib Combined With Chemotherapy - Metastatic Colorectal Cancer (CRC) | Phase 2 | Recruiting | The Methodist Hospital Research Institute | 50 | 2026-01-27 | 2026-04-09 |
| A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. DSP107 + Atezolizumab, Fruquintinib - Colorectal Cancer | Phase 2 | Recruiting | Kahr Bio Australia Pty Ltd | 90 | 2026-01-16 | 2026-08-20 |
| Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer Oxaliplatin intravenous, 5 FU bolus, Folinic acid - Metastatic Colorectal Carcinoma (mCRC) | Phase 2 | Not yet recruiting | Federation Francophone de Cancerologie Digestive | 74 | 2025-12-31 | 2025-09-08 |
| Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma trifluridine/tipiracil, fruquintinib - Metastatic Oesogastric Adenocarcinoma | Phase 3 | Recruiting | Federation Francophone de Cancerologie Digestive | 324 | 2025-12-15 | 2026-02-05 |
| A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment Aipalolitovorelizumab, Fruquintinib - Colorectal Cancer | Phase 2 | Not yet recruiting | Harbin Medical University | 18 | 2025-12-01 | 2025-11-17 |
| Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer Fruquintinib, Iparomlimab and Tuvonralimab, Paclitaxel (albumin-bound) - Gastric Cancer Adenocarcinoma Metastatic | Phase 2 | Recruiting | Dai, Guanghai | 68 | 2025-12-01 | 2026-02-11 |
| - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases Fruquintinib, Tislelizumab, Trifluridine/tipiracil - Metastatic Colorectal Cancer | Phase 2 | Recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 140 | 2025-10-27 | 2025-12-12 |
| A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer Fruquintinib+ Lonsurf (trifluridine and tipiracil), Fruquintinib - Colorectal Cancer | Phase 2 | Recruiting | Criterium, Inc. | 120 | 2025-10-27 | 2026-10-15 |
| Fruquintinib Combined With Standard Chemotherapy Versus Standard Chemotherapy as First-line Treatment for Advanced pMMR Endometrial Cancer Fruquintinib - Endometrial Cancer | Phase 2 | Not yet recruiting | Sun Yat-sen University | 128 | 2025-10-15 | 2025-09-12 |
| A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL) fruquintinib, FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) - Colon Cancer, Rectal Cancer | Phase 2 | Recruiting | SCRI Development Innovations, LLC | 60 | 2025-09-29 | 2026-06-12 |
| A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy Tislelizumab, Fruquintinib - Minimal Residual Disease, Adjuvant Chemotherapy | Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 15 | 2025-09-18 | 2026-08-12 |
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Colorectal Neoplasms (44) · Stomach Neoplasms (8) · Colonic Neoplasms (6) · Carcinoma, Non-Small-Cell Lung (3) · Endometrial Neoplasms (3) · Neoplasms (3) · Rectal Neoplasms (3) · Sarcoma (3) · Carcinoma, Hepatocellular (2) · Esophageal Neoplasms (2) · Neoplasm Metastasis (2) · Triple Negative Breast Neoplasms (2) · Bone Neoplasms (1) · Breast Neoplasms (1) · Burkitt Lymphoma (1)
Hutchison Medipharma Limited (12) · Fudan University (9) · Hutchmed (8) · Sun Yat-sen University (4) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (3) · Federation Francophone de Cancerologie Digestive (3) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (3) · China Medical University, China (2) · Dai, Guanghai (2) · Fujian Medical University (2) · Genor Biopharma Co., Ltd. (2) · Huazhong University of Science and Technology (2) · Takeda (2) · AskGene Pharma, Inc. (1) · Barbara Ann Karmanos Cancer Institute (1)
China (69) · United States (17) · France (5) · Australia (3) · Germany (3) · Austria (2) · Italy (2) · Japan (2) · Poland (2) · South Korea (2) · Belgium (1) · Czechia (1) · Estonia (1) · Hungary (1) · Malaysia (1)
Weijian Guo (2) · William Schelman, MD, PhD (2) · Yunpeng Liu, PhD (2) · Abdullah Esmail, MD (1) · Abi Vainstein-Haras (1) · Aiping Zhou, M.D. (1) · Alexander Stein, Prof. Dr. (1) · Arvind Dasari, MD (1) · Dawei Li, PhD (1) · Dingwei Ye (1) · Fei Ma, M.D. (1) · Guoliang Shao (1) · Hongli Liu, PhD (1) · Hongyan Yin (1)
PMID 29946728, PMID 28103904, PMID 22767582, PMID 23642329, PMID 27299749, PMID 29528793, PMID 31272709, PMID 31999946, PMID 32901330, PMID 33325251, PMID 33993740, PMID 34408440, PMID 36628898, PMID 37133585, PMID 37331369, PMID 37842200, PMID 39395266, PMID 39806128, PMID 39952149, PMID 40022044, PMID 40163688, PMID 40485075, PMID 40888992, PMID 41246975, PMID 41423492, PMID 9006748
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