NCT06591520进行中（未招募）3 期
A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer
Akeso2 个研究点 分布在 1 个国家目标入组 682 人开始时间: 2024年10月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 682
- 试验地点
- 2
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide written informed consent.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Has a life expectancy of at least 3 months.
- •Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC).
- •Has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic BTC.
- •Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Has adequate organ function.
排除标准
- •Has other malignancies within 5 years prior to enrollment.
- •Is currently participating in a study of an investigational agent or using an investigational device.
- •Has known active central nervous system (CNS) metastases.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- •Has an active infection requiring systemic therapy.
- •Has known active Hepatitis B or Hepatitis C.
- •History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- •Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
- •Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
研究组 & 干预措施
AK112 + Gemcitabine + Cisplatin
Experimental
干预措施: AK112, Gemcitabine, Cisplatin (Drug)
Durvalumab + Gemcitabine + Cisplatin
Active Comparator
干预措施: Durvalumab, Gemcitabine, Cisplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 2 years
OS is the time from randomization to death due to any cause.
次要结局
- Progression Free Survival (PFS)(Up to approximately 2 years)
- Objective Response Rate (ORR)(Up to approximately 2 years)
- Duration of Response (DoR)(Up to approximately 2 years)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)
- Adverse Events (AEs)(Up to approximately 2 years)
研究者
研究点 (2)
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