RecruitingPhase 3NCT05919030

A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma

Chemoradiation Versus Chemotherapy in Combination with Tislelizumab As First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma with Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial


Sponsor

Renmin Hospital of Wuhan University

Enrollment

155 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called tislelizumab to standard chemoradiation (chemotherapy combined with radiation) works better as a first-line treatment for people with advanced esophageal squamous cell carcinoma — cancer of the squamous cells lining the food pipe — that has low levels of a protein called PD-L1. **You may be eligible if:** - You have been diagnosed with squamous cell carcinoma of the esophagus, confirmed by biopsy - Your cancer is advanced, recurrent, or has spread and cannot be cured with surgery or radiation alone - Your tumor has low PD-L1 expression (CPS score below 10) - You have not received prior systemic (whole-body) anti-cancer treatment for your advanced disease - You have at least one measurable tumor on imaging - You are in good enough physical health to undergo treatment (ECOG performance status 0 or 1) **You may NOT be eligible if:** - You have active or symptomatic brain or spinal cord metastases - You have an active autoimmune disease - You have HIV, active hepatitis B, or active hepatitis C - You have previously received immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.) - You have serious uncontrolled medical conditions or active infections 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

RADIATIONIntensity-modulated radiotherapy (IMRT)

Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy/3Gy

DRUGTislelizumab

200 mg IV Q3W

DRUGCisplatin

During concurrent radiation therapy: 25 mg/m² IV QW During consolidation therapy: 75 mg/m² IV Q3W

DRUGNab paclitaxel

During concurrent radiation therapy: 75 mg/m² IV QW During consolidation therapy: 220 mg/m² IV Q3W


Locations(1)

Renmin hosptial of Wuhan University

Wuhan, Hubei, China

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NCT05919030


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