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NCT05823311 · ClinicalTrials.gov record · last posted 2025-02-10

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

StatusRecruiting
PhasePhase 3
Started2023-09-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-09
notable
Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University → Second Affiliated Hospital, Zhejiang University, School of Medicine
WasSecond Affiliated Hospital, School of Medicine, Zhejiang University
NowSecond Affiliated Hospital, Zhejiang University, School of Medicine
Trial Details
NCT Number NCT05823311
Lead Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: The First Affiliated Hospital of Zhengzhou University, The Affiliated Tumor Hospital of Xinjiang Medical University
Conditions Advanced Cholangiocarcinoma
Enrollment 80 participants
Start Date 2023-09-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-10