Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer.
The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
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
- •Eighteen years and older;
- •Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
- •Previously untreated with systemic therapy; Subjects who developed recurrent disease >6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
- •Liver function Child-Pugh A or B;
- •Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- •Life expectancy of at least 12 weeks;
- •At least one measurable lesion per RECIST 1.1;
- •Adequate organ function
排除标准
- •Specific anti-tumor treatment prior to 4 weeks;
- •more than 50% liver metastasis ;
- •Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
- •History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
- •Women who are pregnant or in the period of lactation;
- •Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;
研究组 & 干预措施
KN035
KN035 plus Gemcitabine & oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle.
Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.
干预措施: KN035 plus Gemcitabine & oxaliplatin (Drug)
Gemcitabine & oxaliplatin
Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.
干预措施: Gemcitabine & oxaliplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Observed by 12 weeks after progressive disease or end of treatment
was defined as the time from randomization to death due to any cause.
次要结局
- Progression Free Survival (PFS)(Observed by 6 weeks)
- Objective response rate (ORR)(Observed by 6 weeks)
- Disease control rate (DCR)(Observed by 6 weeks)
- Duration of Response (DOR)(Observed by 6 weeks)
- Time to progression (TTP)(Observed by 6 weeks)