A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 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,we aim 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
- Non 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 85 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.
- •the world health organization (WHO)/ECOG physical state (PS) to 0 or
- •at least 1 RECIST 1.1 standard target lesions.
- •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: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 109 / L; platelet count 100 x 109 / L.
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.
研究组 & 干预措施
GPLET
intravenous gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8; oral lenvatinib 8 mg/day (<60kg) or 12 mg/ d（≥60kg）from days 1 to 21; intravenous tislelizumab 200 mg on day 15
干预措施: Lenvatinib, tislelizumab, gemcitabine and cisplatin (Drug)
GP
intravenous gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8
干预措施: gemcitabine and cisplatin (Drug)
结局指标
主要结局
objective remission rate (ORR)
时间窗: 4 cycle treatment (each cycle is 21 days)
According to RECIST v1.1, 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)