A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced BTC
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).
详细描述
Biliary Tract Carcinoma (BTC) have insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy.
Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •• Subjects with a histopathological or cytologically diagnosis of BTC
- •The participants must be required to sign an informed consent
- •At least one measurable lesion (RECIST 1.1)
- •No previous systematic treatment for BTC
- •Child-Pugh Score, Class A
- •ECOG performance status 0 or 1
- •Adequate organ function
- •Life expectancy of at least 3 months
排除标准
- •• Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
- •Known history of serious allergy to any monoclonal antibody
- •Known central nervous system metastases and/or leptomeningeal disease prior to treatment
- •Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
- •Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
- •Any active malignancy prior to the start of treatment
- •Active or history of autoimmune disease
- •Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- •Pregnant or lactating women
研究组 & 干预措施
GP+PD-1+Tight
Experimental: Tislelizumab 200mg IV Q3W + Ociperlimab 900mg IV Q3W + GP (gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W) Gemcitabine/Cisplatin will be administered on D1/D8 in every three weeks cycle and up to 8 cycles.
Tislelizumab and Ociperlimab will be administered on D1 in every three weeks cycle, until the disease progression, intolerable toxicity, death, withdrawal of consent.
干预措施: GP+PD-1+Tight (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 24 months
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs.
次要结局
- 6-months/12-months PFS rate(12 months)
- Overall Survival (OS）(24 months)
- Disease control rate (DCR)(24 months)
- Duration of response (DoR)(24 months)
- Progression-free survival (PFS)(24 months)
- 6-months/12-months OS rate(12 months)
- Adverse Events (AEs)(24 months)