NCT06061146

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 70 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Arm A	anti-PD-1 immunotherapy
DRUG	Arm A	chemotherapy
RADIATION	Arm A	Radiation Concurrent Radiation, 1.8Gy/f, 28f
DRUG	Arm B	chemotherapy
RADIATION	Arm B	Radiation Concurrent Radiation, 1.8Gy/f, 28f

Timeline

• Start date: 2023-10-05
• Primary completion: 2024-10-01
• Completion: 2026-10-01
• First posted: 2023-09-29
• Last updated: 2023-12-26

Locations

1 site across 1 country: China