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.
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.
Active or previously documented autoimmune disease or inflammatory disease.
Uncontrolled complications.
History of other primary malignancies.
Active infection.
Parallel
Lenvatinib, tislelizumab, gemcitabine and cisplatin
DrugLenvatinib, tislelizumab, gemcitabine and cisplatin
gemcitabine and cisplatin
Druggemcitabine and cisplatin
objective remission rate (ORR)
According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)
progression-free survival (PFS)
The time between the date of randomization and the date of radiographic progression as defined by RECIST1.1
Overall survival time (OS)
The time between the date of randomization and death from any cause
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