22 completed, 18 recruiting, 10 active not recruiting, 7 not yet recruiting. 38 Phase 2, 21 Phase 1, 10 Phase 3, 4 Not applicable, 1 Early Phase 1.
Follow Trifluridine: new trials by email Literature Review of Trifluridine trials Research Report on Trifluridine
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 |
|---|---|---|---|---|---|---|
| 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 |
| Efficacy and Safety of Trifluridine/Tipiracil (TAS-102) Combined With Bevacizumab and Serplulimab in Patients With Metastatic Colorectal Cancer Undergoing Cytoreductive Surgery: A Single-Arm, Single-Center Clinical Study Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumab - Colorectal Cancer (CRC) | Phase 1 | Not yet recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 20 | 2026-06-06 | 2026-06-08 |
| SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer SBRT, Sintilimab, Bevacizumab - Colorectal Neoplasms | Phase 2 | Not yet recruiting | Shanghai Zhongshan Hospital | 58 | 2026-06-01 | 2026-04-17 |
| A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil (FTD-TPI) - Metastatic Colorectal Cancer | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 1020 | 2026-05-06 | 2026-10-08 |
| ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer SOC (Standard of care), Bevacizumab, Cetuximab - Dynamic Tumor Resistance, Metastatic Colorectal Cancer | Early Phase 1 | Recruiting | M.D. Anderson Cancer Center | 100 | 2026-04-22 | 2026-10-14 |
| 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 |
| A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer Trifluridine/Tipiracil (TAS-102) combined with Apatinib - Advanced Gastric Cancer | Not applicable | Not yet recruiting | Anhui Provincial Cancer Hospital | 30 | 2026-01-08 | 2026-01-28 |
| Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil for Advanced Metastatic Colorectal Cancer Fruquintinib Combined With trifluridine/tipiracil, Bevacizumab combined with trifluridine/tipiracil - Metastatic Colorectal Cancer (CRC), Colorectal Cancer | Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 292 | 2025-12-31 | 2026-01-21 |
| Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial Trifluridine/tipiracil plus fruquintinib, trifluridine/tipiracil plus bevacizumab - Refractory Metastatic Colorectal Cancer | Phase 2 | Not yet recruiting | Sun Yat-sen University | 236 | 2025-12-01 | 2025-12-03 |
| A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer Suvemcitug injection, trifluridine/tipiracil tablets, Suvemcitug placebo injection, trifluridine/tipiracil tablets - Refractory Metastatic Colorectal Cancer | Phase 3 | Recruiting | Jiangsu Simcere Pharmaceutical Co., Ltd. | 464 | 2025-11-12 | 2026-01-22 |
| 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 |
| Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC Trifluridine/tipiracil (TAS-102) plus bevacizumab - Colo-rectal Cancer, Third-line and Beyond Therapy | Phase 2 | Recruiting | Ruijin Hospital | 50 | 2025-08-01 | 2025-07-25 |
| The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial RetroNectin active Killer cells, TAS-102 (trifluridine and tipiracil, Lonsurf®) - Gastric (Stomach) Cancer, Biological Therapy | Phase 2 | Recruiting | Chinese PLA General Hospital | 90 | 2025-07-01 | 2025-10-08 |
| Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab - Metastatic Colorectal Cancer (CRC), Recurrent Colorectal Cancer | Phase 1 / Phase 2 | Recruiting | STCube, Inc. | 52 | 2025-06-09 | 2025-07-11 |
| Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer Pucotenlimab, Bevacizumab, Oxaliplatin - Rectal Adenocarcinoma | Phase 2 | Not yet recruiting | Sir Run Run Shaw Hospital | 33 | 2025-04-01 | 2025-03-12 |
| Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer Trifluridine/Tipiracil + Regorafenib, Trifluridine/tipiracil + bevacizumab - Colorectal Cancer Metastatic, Colorectal Cancer Recurrent | Phase 3 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 302 | 2025-04-01 | 2025-05-28 |
| Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy bemarituzumab, paclitaxel, ramucirumab, bemarituzumab, irinotecan, bemarituzumab, trifluridine/tipiracil - Metastatic Gastro-esophageal Adenocarcinoma | Phase 2 | Active not recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 126 | 2025-03-03 | 2026-01-07 |
| Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab - Gastric Cancer Adenocarcinoma Metastatic | Phase 2 | Recruiting | LIN YANG | 31 | 2024-11-14 | 2024-12-02 |
| A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001) Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）, IBI343 - Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma | Phase 3 | Active not recruiting | Innovent Biologics (Suzhou) Co. Ltd. | 464 | 2024-06-30 | 2026-05-13 |
| Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer . nal-IRI /Experimental, Ramucirumab /Experimental, Trifluridine/Tipiracil /Experimental - Metastatic Gastric Adenocarcinoma, Second Line | Phase 1 / Phase 2 | Recruiting | National Health Research Institutes, Taiwan | 45 | 2024-04-01 | 2026-04-09 |
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Colorectal Neoplasms (41) · Colonic Neoplasms (9) · Rectal Neoplasms (8) · Neoplasm Metastasis (5) · Neoplasms (4) · Stomach Neoplasms (3) · AIDS-Related Opportunistic Infections (2) · Acquired Immunodeficiency Syndrome (2) · HIV Infections (2) · Pancreatic Neoplasms (2) · Adenocarcinoma (1) · Bile Duct Neoplasms (1) · Carcinoma (1) · Gallbladder Neoplasms (1) · Herpes Simplex (1)
Academic and Community Cancer Research United (4) · Institut de Recherches Internationales Servier (4) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (3) · M.D. Anderson Cancer Center (3) · Roswell Park Cancer Institute (3) · Innovent Biologics (Suzhou) Co. Ltd. (2) · Mayo Clinic (2) · Second Affiliated Hospital, Zhejiang University, School of Medicine (2) · University of California, Irvine (2) · AHS Cancer Control Alberta (1) · Adagene Inc (1) · Amgen (1) · Anhui Provincial Cancer Hospital (1) · Australasian Gastro-Intestinal Trials Group (1) · Bayer (1)
United States (29) · China (22) · Germany (10) · France (7) · Australia (6) · Italy (6) · South Korea (6) · Spain (6) · Japan (5) · United Kingdom (5) · Austria (4) · Belgium (4) · Poland (4) · Taiwan (4) · Argentina (3)
Christos Fountzilas, MD (2) · Farshid Dayyani, MD, PhD (2) · John H Strickler (2) · Yongkun Sun (2) · Aiping Zhou (1) · Alexander Stein (1) · Alisha Bent, MD (1) · Amit Mahipal (1) · Charles D Lopez, MD, PhD (1) · Christos Fountilas, MD (1) · Drew Rasco, MD (1) · Eric Van Custem, Prof (1) · Hatim Karachiwala, MD (1) · Howard S Hochster (1) · Jennifer Y. Wo, MD (1)
PMID 11230497, PMID 11489791, PMID 11895891, PMID 16271446, PMID 1651156, PMID 17468871, PMID 19349540, PMID 22811849, PMID 23406728, PMID 23880820, PMID 25577133, PMID 26615328, PMID 27091418, PMID 27871319, PMID 30889492, PMID 32497736, PMID 32891715, PMID 33663264, PMID 35738999, PMID 35897060, PMID 36040321, PMID 36622402, PMID 36623495, PMID 36707808, PMID 36814222, PMID 37260368, PMID 37339254, PMID 38202064, PMID 38833658, PMID 39003182, PMID 39244627, PMID 39530624, PMID 39820336, PMID 40200573, PMID 40468090, PMID 40669021, PMID 41781240
P30CA015083 (4), 2015 (2), 2019 (2), 2016 (1), 2017 (1), 2025 (1), P30CA033572 (1), P30CA072720 (1), R37CA282430 (1)