NCT05823311

Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.

Conditions

• Advanced Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib, tislelizumab, gemcitabine and cisplatin	Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.
DRUG	Gemcitabine and cisplatin	Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-04-21
• Last updated: 2025-02-10

Locations

1 site across 1 country: China