RecruitingPhase 2NCT06061146

Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

Tislelizumab Combined With Concurrent Chemoradiation Versus Concurrent Chemoradiation for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Parallel-controlled, Multicenter Phase II Clinical Study

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

136 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown. In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

Eligibility

Min Age: 70 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding an immunotherapy drug called tislelizumab to standard chemotherapy and radiation can improve outcomes for older patients (70+) with locally advanced esophageal squamous cell cancer who cannot have surgery. **You may be eligible if...** - You are 70 years or older - You have been diagnosed with locally advanced squamous cell cancer of the esophagus, confirmed by biopsy - Your cancer is classified as inoperable Stage II-IVb - Your general health is good (ECOG score 0 or 1) **You may NOT be eligible if...** - You are under 70 years old - Your cancer has spread widely to distant organs beyond what is allowed - You have significant heart, lung, liver, or kidney problems - You have had prior treatment for esophageal cancer 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.