A Phase 3 interventional study of Lenvatinib, tislelizumab, gemcitabine and cisplatin and Gemcitabine and cisplatin in Advanced Cholangiocarcinoma, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib.
Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin
Intravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo.
Drug: Gemcitabine and cisplatin
Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.
Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.
Objective remission rate (ORR)
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Time frame: At the end of 4 treatment cycles(each cycle is 21 days)
Progression-free survival (PFS)
The time between the date of randomization and the date of radiographic progression
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Overall survival time (OS)
The time between the date of randomization and death from any cause
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
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Second Affiliated Hospital, School of Medicine, Zhejiang University