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RECRUITING
NCT06061146
PHASE2

Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

70 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2023-10-05

Completion Date

2026-10-01

Last Updated

2023-12-26

Healthy Volunteers

No

Interventions

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

Locations (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China