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Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC - Trial NCT06061146

Access comprehensive clinical trial information for NCT06061146 through Pure Global AI's free database. This Phase 2 trial is sponsored by Tianjin Medical University Cancer Institute and Hospital and is currently Recruiting. The study focuses on Esophageal Cancer. Target enrollment is 136 participants.

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NCT06061146
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06061146
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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

Study Focus

Esophageal Cancer

Arm A

Interventional

drug

Sponsor & Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Timeline & Enrollment

Phase 2

Oct 05, 2023

Oct 01, 2026

136 participants

Primary Outcome

PFS

Summary

This study was conducted in elderly (โ‰ฅ70 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.

ICD-10 Classifications

Carcinoma in situ: Oesophagus
Malignant neoplasm of oesophagus
Malignant neoplasm: Middle third of oesophagus
Malignant neoplasm: Overlapping lesion of oesophagus
Malignant neoplasm: Upper third of oesophagus

Data Source

ClinicalTrials.gov

NCT06061146

Non-Device Trial