Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE


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505(b)(2) Clinical Trials for tipiracil hydrochloride; trifluridine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Novotech (Australia) Pty Limited PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Kahr Bio Australia Pty Ltd PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for tipiracil hydrochloride; trifluridine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01955837 ↗ Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia Completed Taiho Pharmaceutical Co., Ltd. Phase 3 2013-09-01 To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.
NCT02654639 ↗ Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer Terminated Georgetown University Phase 2 2016-02-01 Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
NCT03278106 ↗ TAS-102 in Treating Advanced Biliary Tract Cancers Active, not recruiting National Cancer Institute (NCI) Phase 2 2017-10-20 This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT03278106 ↗ TAS-102 in Treating Advanced Biliary Tract Cancers Active, not recruiting Mayo Clinic Phase 2 2017-10-20 This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for tipiracil hydrochloride; trifluridine

Condition Name

Condition Name for tipiracil hydrochloride; trifluridine
Intervention Trials
Metastatic Colorectal Cancer 22
Colorectal Cancer 9
Stage IV Colorectal Cancer AJCC v8 7
Stage IVB Colorectal Cancer AJCC v8 6
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Condition MeSH

Condition MeSH for tipiracil hydrochloride; trifluridine
Intervention Trials
Colorectal Neoplasms 61
Adenocarcinoma 17
Colonic Neoplasms 9
Carcinoma 8
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Clinical Trial Locations for tipiracil hydrochloride; trifluridine

Trials by Country

Trials by Country for tipiracil hydrochloride; trifluridine
Location Trials
United States 151
China 48
Italy 28
Japan 23
Australia 16
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Trials by US State

Trials by US State for tipiracil hydrochloride; trifluridine
Location Trials
California 14
Texas 13
Florida 11
Illinois 8
Minnesota 8
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Clinical Trial Progress for tipiracil hydrochloride; trifluridine

Clinical Trial Phase

Clinical Trial Phase for tipiracil hydrochloride; trifluridine
Clinical Trial Phase Trials
PHASE3 5
PHASE2 24
PHASE1 7
[disabled in preview] 11
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Clinical Trial Status

Clinical Trial Status for tipiracil hydrochloride; trifluridine
Clinical Trial Phase Trials
Recruiting 49
Not yet recruiting 14
NOT_YET_RECRUITING 12
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Clinical Trial Sponsors for tipiracil hydrochloride; trifluridine

Sponsor Name

Sponsor Name for tipiracil hydrochloride; trifluridine
Sponsor Trials
National Cancer Institute (NCI) 15
Servier 6
Mayo Clinic 4
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Sponsor Type

Sponsor Type for tipiracil hydrochloride; trifluridine
Sponsor Trials
Other 98
Industry 42
NIH 15
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