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Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

NCT06061146 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-12-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    collaborator OTHER

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Hunan Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Wencheng Zhang, M.D · Tian jin cancer hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2024-10-01
Completion
2026-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06061146 on ClinicalTrials.gov