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.
Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
Expected survival period > 12 weeks.
The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1.
There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
Active or previously documented autoimmune disease or inflammatory disease.
Uncontrolled complications.
History of other primary malignancies.
Active infection.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Affiliated Tumor Hospital of Xinjiang Medical University
Collaborator