NCT06061146Recruiting

Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

Name: Clinical Trial NCT06061146
Creator: Tianjin Medical University Cancer Institute and Hospital
Keywords: Esophageal Cancer, Arm A, Phase 2, drug, clinical trial, China

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

Tianjin Medical University Cancer Institute and HospitalPhase 2ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Esophageal Cancer
Drug/Device/Intervention: Arm A
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Tianjin Medical University Cancer Institute and Hospital
Location: Tianjin, China

Timeline & enrollment

Phase: Phase 2
Start date: Oct 05, 2023
End date: Oct 01, 2026
Enrollment: 136 participants

Primary outcome

PFS

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.

ICD-10 classifications

Carcinoma in situ: OesophagusMalignant neoplasm of oesophagusMalignant neoplasm: Middle third of oesophagusMalignant neoplasm: Overlapping lesion of oesophagusMalignant neoplasm: Upper third of oesophagus

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06061146
Type: Non-Device Trial

About this record

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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