OncoMatch/Clinical Trials/NCT05532059
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Is NCT05532059 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lenvatinib, tislelizumab, gemcitabine and cisplatin and gemcitabine and cisplatin for advanced cholangiocarcinoma.
Treatment: Lenvatinib, tislelizumab, gemcitabine and cisplatin · gemcitabine and cisplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Metastatic disease required
unresectable advanced or metastatic cholangiocarcinoma patients. at least 1 RECIST 1.1 standard target lesions.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy
not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
Lab requirements
Blood counts
9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 10^9 / L; platelet count 100 x 10^9 / L.
adequate organ and bone marrow function, defined as follows: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 10^9 / L; platelet count 100 x 10^9 / L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify