RecruitingPhase 3

Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

Australia, Japan, South Korea784 participantsStarted 2026-06-24

Plain-language summary

To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;
. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);
. Has radiographically measurable disease per RECIST v1.1.
. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
. Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.

Exclusion criteria

. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
. Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival (OS)

Timeframe: Up to approximately 45 months

Trial details

NCT IDNCT07710885

SponsorTaiho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-04-30

Contact for this trial

Kotaro Suto

+81-3-3294-4527 th-FOENIX-BTC-Clin.Dev@taiho.co.jp

View on ClinicalTrials.gov More Biliary Tract Cancer trials