5 active not recruiting, 5 recruiting, 3 completed, 3 not yet recruiting. 20 Phase 2, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 20 | Active not recruiting 5, Recruiting 5, Completed 3, Not yet recruiting 3, Terminated 2, Unknown 2 |
| Phase 1 | 6 | Active not recruiting 3, Completed 1, Recruiting 1, Unknown 1 |
Follow tipiracil: new trials by email Literature Review of tipiracil trials Research Report on tipiracil
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 |
| Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil, Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab - Colorectal Cancer | Phase 1 / Phase 2 | Active not recruiting | Tianjin Medical University Cancer Institute and Hospital | 106 | 2023-07-01 | 2026-03-24 |
| Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®) - Gastric and Gastroesophageal Junction Adenocarcinoma | Phase 1 / Phase 2 | Active not recruiting | Yonsei University | 75 | 2022-12-01 | 2025-07-11 |
| Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine trifluridine/tipiracil + XB2001, trifluridine/tipiracil + placebo - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Active not recruiting | Centre Georges Francois Leclerc | 160 | 2022-10-13 | 2025-05-30 |
| Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Unknown | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 70 | 2022-10-01 | 2024-04-02 |
| Irinotecan, TAS-102 Plus Bevacizumab as a Third-Line or Beyond Therapy in mCRC Patients Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab - Metastatic Colorectal Cancer | Phase 2 | Unknown | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 35 | 2022-08-01 | 2024-09-24 |
| TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy TAS-102 - Colorectal Cancer | Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 30 | 2022-06-06 | 2026-10-01 |
| iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Irinotecan, Oxaliplatin, TAS 102 (Trifluridine/Tipiracil) - Gastroesophageal Junction Adenocarcinoma, Advanced Gastric Carcinoma | Phase 2 | Completed | AHS Cancer Control Alberta | 7 | 2021-10-27 | 2024-06-14 |
| A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations Selinexor, Pembrolizumab, Trifluridine - Metastatic Colorectal Cancer | Phase 2 | Terminated | Karyopharm Therapeutics Inc | 13 | 2021-06-29 | 2023-11-03 |
| Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer Regorafenib then Trifluridine/Tipiracil, Trifluridine/Tipiracil then Regorafenib - Metastatic Colorectal Cancer | Phase 2 | Terminated | UNICANCER | 234 | 2020-11-23 | 2025-03-30 |
| A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy Trifluridine/tipiracil + bevacizumab, Capecitabine + bevacizumab - Metastatic Colorectal Cancer | Phase 2 | Completed | Institut de Recherches Internationales Servier | 154 | 2016-04-29 | 2024-08-20 |
| A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer Panitumumab + TAS-102 - Colorectal Cancer | Phase 1 / Phase 2 | Completed | Takeda | 56 | 2015-12-07 | 2019-07-31 |
Colorectal Neoplasms (13) · Colonic Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Stomach Neoplasms (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (3) · AHS Cancer Control Alberta (1) · Centre Georges Francois Leclerc (1) · Chinese PLA General Hospital (1) · Criterium, Inc. (1) · Institut de Recherches Internationales Servier (1) · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (1) · Karyopharm Therapeutics Inc (1) · LIN YANG (1) · M.D. Anderson Cancer Center (1) · National Health Research Institutes, Taiwan (1) · Ruijin Hospital (1) · Shanghai Zhongshan Hospital (1) · Sun Yat-sen University (1) · Takeda (1)
China (9) · France (3) · United States (3) · Belgium (2) · Germany (2) · Australia (1) · Brazil (1) · Canada (1) · Denmark (1) · Italy (1) · Japan (1) · Netherlands (1) · Poland (1) · Russia (1) · South Korea (1)
Yongkun Sun (2) · Aiping Zhou (1) · Alisha Bent, MD (1) · Eric Van Custem, Prof (1) · Hatim Karachiwala, MD (1) · Lin Yang (1) · Nai-Jung Chiang, MD-PhD (1) · Salah Eddin Al-Batran, Prof. Dr. (1) · Sylvie Lorenzen, Prof. Dr. (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 32497736, PMID 36623495, PMID 38202064, PMID 39530624, PMID 39820336, PMID 40468090, PMID 40669021
2015 (1), 2019 (1)