tipiracil: Clinical Trials

34 trials of tipiracil, newest first

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10 recruiting, 9 completed, 6 not yet recruiting, 5 active not recruiting. 20 Phase 2, 10 Phase 1, 5 Phase 3, 2 Not applicable, 1 Early Phase 1.

By phase and status

PhaseTrialsStatus
Phase 220Active not recruiting 5, Recruiting 5, Completed 3, Not yet recruiting 3, Terminated 2, Unknown 2
Phase 110Active not recruiting 3, Completed 3, Recruiting 2, Not yet recruiting 1, Unknown 1
Phase 35Recruiting 3, Completed 1, Not yet recruiting 1
Not applicable2Completed 1, Not yet recruiting 1
Early Phase 11Recruiting 1

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Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
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 1Not yet recruitingSecond Affiliated Hospital, Zhejiang University, School of Medicine202026-06-062026-06-08
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 2Not yet recruitingShanghai Zhongshan Hospital582026-06-012026-04-17
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 3RecruitingEMD Serono Research & Development Institute, Inc.10202026-05-062026-10-08
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 1RecruitingM.D. Anderson Cancer Center1002026-04-222026-10-14
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 3Not yet recruitingChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.1422026-03-012026-03-19
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 applicableNot yet recruitingAnhui Provincial Cancer Hospital302026-01-082026-01-28
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 2Not yet recruitingCancer Institute and Hospital, Chinese Academy of Medical Sciences2922025-12-312026-01-21
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 2Not yet recruitingSun Yat-sen University2362025-12-012025-12-03
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 3RecruitingJiangsu Simcere Pharmaceutical Co., Ltd.4642025-11-122026-01-22
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 2RecruitingCriterium, Inc.1202025-10-272026-10-15
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Trifluridine/tipiracil (TAS-102) plus bevacizumab - Colo-rectal Cancer, Third-line and Beyond Therapy
Phase 2RecruitingRuijin Hospital502025-08-012025-07-25
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 2RecruitingChinese PLA General Hospital902025-07-012025-10-08
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 3RecruitingSecond Affiliated Hospital, Zhejiang University, School of Medicine3022025-04-012025-05-28
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 2Active not recruitingInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest1262025-03-032026-01-07
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 2RecruitingLIN YANG312024-11-142024-12-02
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 2RecruitingNational Health Research Institutes, Taiwan452024-04-012026-04-09
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 2Active not recruitingTianjin Medical University Cancer Institute and Hospital1062023-07-012026-03-24
An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions
Regorafenib (BAY73-4506, Stivarga®), TAS-102 (trifluridine and tipiracil, Lonsurf®), Bevacizumab - Metastatic Colorectal Cancer (mCRC)
CompletedBayer8182023-04-242025-11-12
Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer
Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®) - Gastric and Gastroesophageal Junction Adenocarcinoma
Phase 1 / Phase 2Active not recruitingYonsei University752022-12-012025-07-11
Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans
Trifluridine and Tipiracil Tablets, Lonsurf® - Solid Tumor Cancer
Not applicableCompletedShandong New Time Pharmaceutical Co., LTD762022-11-212026-03-25

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Conditions studied

Colorectal Neoplasms (23)  ·  Colonic Neoplasms (3)  ·  Neoplasm Metastasis (1)  ·  Neoplasms (1)  ·  Parkinson Disease 4, Autosomal Dominant Lewy Body (1)  ·  Stomach Neoplasms (1)

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (3)  ·  M.D. Anderson Cancer Center (2)  ·  Second Affiliated Hospital, Zhejiang University, School of Medicine (2)  ·  University of California, Irvine (2)  ·  AHS Cancer Control Alberta (1)  ·  Anhui Provincial Cancer Hospital (1)  ·  Bayer (1)  ·  Centre Georges Francois Leclerc (1)  ·  Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (1)  ·  Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. (1)  ·  Chinese PLA General Hospital (1)  ·  Criterium, Inc. (1)  ·  EMD Serono Research & Development Institute, Inc. (1)  ·  Institut de Recherches Internationales Servier (1)  ·  Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (1)

Countries

China (16)  ·  United States (9)  ·  Germany (5)  ·  France (4)  ·  Australia (3)  ·  Belgium (3)  ·  Canada (3)  ·  Japan (3)  ·  South Korea (3)  ·  Spain (3)  ·  Taiwan (3)  ·  United Kingdom (3)  ·  Argentina (2)  ·  Denmark (2)  ·  Italy (2)

Top investigators

Farshid Dayyani, MD, PhD (2)  ·  Yongkun Sun (2)  ·  Aiping Zhou (1)  ·  Alisha Bent, MD (1)  ·  Eric Van Custem, Prof (1)  ·  Hatim Karachiwala, MD (1)  ·  Jing Hao, Prof. (1)  ·  Lin Yang (1)  ·  Nai-Jung Chiang, MD-PhD (1)  ·  Salah Eddin Al-Batran, Prof. Dr. (1)  ·  Scott Kopetz, MD (1)

Results publications

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 36622402, PMID 36623495, PMID 37260368, PMID 38202064, PMID 38833658, PMID 39530624, PMID 39820336, PMID 40468090, PMID 40669021

NIH funding

2015 (1), 2019 (1), 2025 (1)