Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Lenvatinib, tislelizumab, gemcitabine and cisplatin: Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.

Gemcitabine and cisplatin: Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.

Study 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.

Eligibility

Primary outcome measure(s)

• Objective remission rate (ORR) — At the end of 4 treatment cycles(each cycle is 21 days)
  The proportion of patients with at least one complete response (CR) or partial response (PR) (%)

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition