RecruitingPhase 3NCT05823311

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

A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

80 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding lenvatinib (a drug that blocks tumor blood vessel growth) and tislelizumab (an immunotherapy drug) to standard chemotherapy (gemcitabine and cisplatin) can improve treatment outcomes for people with advanced or unresectable cholangiocarcinoma — a cancer of the bile ducts. This combination aims to attack the cancer through multiple pathways at once. **You may be eligible if...** - Your bile duct cancer has been confirmed by biopsy and cannot be surgically removed - You are in good health (ECOG 0–1) with an expected survival of more than 12 weeks - You have not previously received immunotherapy (anti-PD-1/PD-L1 or anti-CTLA-4 drugs) - Your blood counts and organ function tests are within acceptable ranges **You may NOT be eligible if...** - You have already received immunotherapy for this cancer - You have uncontrolled high blood pressure or serious heart conditions - You have active autoimmune disease - 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLenvatinib, tislelizumab, gemcitabine and cisplatin

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

DRUGGemcitabine and cisplatin

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


Locations(1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05823311


Related Trials