NCT07710885招募中3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 784
- 试验地点
- 21
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 45 months
* To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC whose primary tumor site is intrahepatic or extrahepatic cholangiocarcinoma * To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC
次要结局
- Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments(Up to approximately 45 months)
- Adverse events (AEs)(Up to approximately 45 months)
- 6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments(Up to approximately 45 months)
- Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments(Up to approximately 45 months)
- Progression-Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 using Blinded Independent Central Review (BICR) and Investigator assessment(Up to approximately 45 months)
研究者
研究点 (21)
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