RecruitingPhase 2NCT05532059

Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

100 participants

Start Date

Jan 31, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Cholangiocarcinoma

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,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a four-drug combination — lenvatinib, tislelizumab (immunotherapy), gemcitabine, and cisplatin (chemotherapy) — as a first-line treatment for people with advanced or metastatic cholangiocarcinoma (bile duct cancer) that cannot be surgically removed. **You may be eligible if...** - You have histologically confirmed advanced or metastatic cholangiocarcinoma (bile duct cancer) that is unresectable - You have at least one measurable tumor on imaging - You have not previously received immunotherapy - You are in good functional health (ECOG/WHO 0–1) with adequate blood counts (hemoglobin ≥9 g/dL, neutrophils and platelets within normal range) **You may NOT be eligible if...** - You have active or prior autoimmune or inflammatory disease - You have other uncontrolled medical complications - You have another primary malignancy - You have an active uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib, tislelizumab, gemcitabine and cisplatin

Lenvatinib, tislelizumab, gemcitabine and cisplatin

DRUGgemcitabine and cisplatin

gemcitabine and cisplatin

Locations(1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05532059

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