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 (FOENIX-BTC)

未提供0 个研究点目标入组 784 人开始时间: 待定

适应症

试验速览

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•(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 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.
•(4) Has a tumor tissue sample available for biomarker analysis in a quantity sufficient
•(5) Has an WHO/ECOG PS of 0 or 1 before administration of study treatment;
•(6) Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study 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 FGFR-directed therapy including futibatinib
•(4) Has prior treatment with an anti-PD-L1, anti-PD-1, anti-Cytotoxic T-lymphocyteassociated protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other ICI or agonist as monotherapy or in combination
•(5) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

发起方

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