Futibatinib and zimberelimab with chemotherapy for first treatment of advanced biliary tract cancer
Tests futibatinib and zimberelimab with chemotherapy in advanced bile duct cancer.
Plain-language title generated from the registry record
Registry title: Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
Key facts
- Where
- Aichi, Fukuoka, Hokkaido, Kanagawa, Miyagi, Osaka, Tokyo, Toyama, and Wakayama, JapanSee the 11 sites
- Phase
- Phase 3
Where in Japan
- AichiAichi, JapanNot yet recruiting
- FukuokaFukuoka, JapanNot yet recruiting
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanTaking people
- HokkaidoHokkaido, JapanNot yet recruiting
- Kanagawa Cancer CenterKanagawa, JapanNot yet recruiting
- MiyagiMiyagi, JapanNot yet recruiting
- OsakaOsaka, JapanNot yet recruiting
- TokyoTokyo, JapanNot yet recruiting
- The Cancer Institute HospitalTokyo, JapanTaking people
- Toyama University HopspitalToyama, JapanTaking people
- Wakayama Medical University HospitalWakayama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Taiho Pharmaceutical Co., Ltd.
- Trial code
- NCT07710885
- Record updated
- 17 July 2026
- Original description
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 cancerRead full original descriptionShow less
A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers
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
Inclusion: 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); Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion; 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: Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib; History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination; History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis; 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.