A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective remission rate (ORR)
研究概览
简要总结
Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery.
As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment.
Therefore, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.
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
- Double (Participant, Care Provider)
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
- •Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
- •Expected survival period > 12 weeks.
- •The World Health Organization (WHO) / ECOG physical status (PS) was 0 or
- •There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
- •Not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
- •Adequate organ and bone marrow function, defined as follows: Hemoglobin (Hb)≥9.0g/dL; Neutrophils (ANC) ≥ 1.5* 10^9/L; Platelet (Pt) ≥ 50*10^9/L; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN.
- •Voluntary participation and signing of informed consent.
排除标准
- •Active or previously documented autoimmune disease or inflammatory disease.
- •Uncontrolled complications.
- •History of other primary malignancies.
- •Active infection.
- •Women who are pregnant or breastfeeding.
- •Patients with severe allergic history or specific constitution.
- •Researchers consider it inappropriate to participate in the test.
研究组 & 干预措施
GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)
Intravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib.
干预措施: Lenvatinib, tislelizumab, gemcitabine and cisplatin (Drug)
CG (Gemcitabine and Cisplatin)
Intravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo.
干预措施: Gemcitabine and cisplatin (Drug)
结局指标
主要结局
Objective remission rate (ORR)
时间窗: At the end of 4 treatment cycles(each cycle is 21 days)
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
次要结局
- Progression-free survival (PFS)(From date of randomization until the date of first documented progression, assessed up to 60 months)
- Overall survival time (OS)(From date of randomization until the date of death from any cause, assessed up to 60 months)