drugset / Trial / NCT05532059

Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

NCT05532059 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-01-31
Primary completion
2025-08-31
Completion
2028-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Comparator Cisplatin Other / unclassified 25 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications