NCT06465563进行中（未招募）2 期
SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy for the First-Line Treatment of Advanced Biliary Tract Cancer: A Randomized and Exploratory Cohort, Open-label, Multicenter, Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Objective Response Rate
研究概览
简要总结
Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer. Cohort C: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab and Bevacizumab in combination with Cisplatin Plus Gemcitabine (CisGem) as first-line treatment in patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~75 years old, both male and female;
- •Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
- •Has not received prior systemic anti-tumor therapy;
- •At least one measurable lesion based on RECIST v1.1 criteria;
- •ECOG PS score: 0-1 points;
- •Expected survival period ≥ 3 months;
- •Adequate organ function;
- •Must take one medically approved contraceptive measure;
- •Patients voluntarily joined the study and signed informed consent.
排除标准
- •history or concurrently has other solid tumor;
- •Patients with liver tumor burden greater than 50% of total liver volume;
- •History of previous hepatic encephalopathy;
- •Patients with biliary obstruction ， at risk of biliary tract infection;
- •Patients with undergone major surgical treatment within 4 weeks before randomization;
- •Patients with any active, known or suspected autoimmune disorder;
- •Patients with active pulmonary tuberculosis;
- •Patients with known history of HIV or active hepatitis;
- •Untreated central nervous system metastasis;
- •Pleural or peritoneal effusion with clinical symptoms;
- •Patients with poorly controlled cardiac clinical symptoms or disease;
- •Patients with abnormal coagulation function and bleeding tendency;
- •Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug;
- •Patients with other potential factors that may affect the study results.
研究组 & 干预措施
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: SHR-8068 (Drug)
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: Adebrelimab (Drug)
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: Cisplatin (Drug)
Arm B: Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: Gemcitabine (Drug)
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: Gemcitabine (Drug)
Arm B: Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: Adebrelimab (Drug)
Arm B: Adebrelimab, Cisplatin and Gemcitabine
Experimental
干预措施: Cisplatin (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)
ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the investigator according to RECIST v1.1.
次要结局
- Disease Control Rate(From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)] (up to approximately 14 months))
- Progression-Free-Survival (PFS)(From randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months))
- Duration of Response (DoR)(From the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months))
研究者
研究点 (2)
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