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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05823311
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Weilin Wang, doctor
Phone +86 0571 87783820
Email wam@zju.edu.cn
Status Recruiting
Phase Phase 3
Start date October 31, 2023
Completion date December 30, 2028

See also
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Active, not recruiting NCT04088188 - Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma Phase 1
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Terminated NCT03773302 - Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations Phase 3
Approved for marketing NCT04507503 - Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements