NCT07229625招募中3 期
A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced 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
- None
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
- •Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
- •No previous systemic anti-tumor treatment has been received;
- •At least one measurable lesion that complies with the RECIST v1.1 standard;
- •ECOG PS score: 0-1 point;
- •The expected survival period is ≥ 3 months;
- •Good organ function level;
- •Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
- •Patients voluntarily joined this study and signed informed consent.
排除标准
- •Other pathological types of cholangiocarcinoma other than adenocarcinoma;
- •Malignant tumor of the ampulla;
- •Have had or concurrently suffered from other malignant tumors;
- •Those with concurrent biliary obstruction and at risk of biliary tract infection;
- •Those with any active or known autoimmune diseases.
研究组 & 干预措施
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
Experimental
干预措施: SHR-8068 Injection (Drug)
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
Experimental
干预措施: Adebrelimab Injection (Drug)
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
Experimental
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
Experimental
干预措施: Cisplatin Injection (Drug)
Durvalumab + Cisplatin and Gemcitabine Group
Active Comparator
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
Durvalumab + Cisplatin and Gemcitabine Group
Active Comparator
干预措施: Cisplatin Injection (Drug)
Durvalumab + Cisplatin and Gemcitabine Group
Active Comparator
干预措施: Durvalumab Injection (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 15 months.
次要结局
- Time to Response (TTR)(Up to 7 months.)
- Adverse events (AEs)(Up to approximately 15 months.)
- Serious adverse events (SAEs)(Up to approximately 15 months.)
- Duration of Response (DoR)(Up to 7 months.)
- Progression free Survival (PFS)(Up to 7 months.)
- Disease Control Rate (DCR)(Up to 7 months.)
- Objective Response Rate (ORR)(Up to 7 months.)
- Time to Progression (TTP)(Up to 7 months.)
研究者
研究点 (1)
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