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

  • End date
    Aug 31, 2028
  • participants needed
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 7 October 2022


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.

Condition Advanced Cholangiocarcinoma
Treatment Gemcitabine and Cisplatin, Lenvatinib, tislelizumab, gemcitabine and cisplatin
Clinical Study IdentifierNCT05532059
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients
the world health organization (WHO)/ECOG physical state (PS) to 0 or 1
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

Exclusion Criteria

Active or previously documented autoimmune disease or inflammatory disease
Uncontrolled complications
History of other primary malignancies
Active infection
Women who are pregnant or breastfeeding
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