NCT07710885 Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
| NCT ID | NCT07710885 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Taiho Pharmaceutical Co., Ltd. |
| Condition | Biliary Tract Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 784 participants |
| Start Date | 2026-06-24 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 784 participants in total. It began in 2026-06-24 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC); * Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion. 3. Has radiographically measurable disease per RECIST v1.1. 4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient. 5. 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: 1. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis; 2. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination; 3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib 4. 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. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07710885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Biliary Tract Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07710885 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 784 participants.
Is NCT07710885 currently recruiting?
Yes, NCT07710885 is actively recruiting participants. Contact the research team at th-FOENIX-BTC-Clin.Dev@taiho.co.jp for enrollment information.
Where is the NCT07710885 trial being conducted?
This trial is being conducted at Brisbane, Australia, Melbourne, Australia, Perth, Australia, Sydney, Australia and 11 additional locations.
Who is sponsoring the NCT07710885 clinical trial?
NCT07710885 is sponsored by Taiho Pharmaceutical Co., Ltd.. The trial plans to enroll 784 participants.
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