Overview

Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma

Status:
NOT_YET_RECRUITING

Trial end date:
2030-10-01

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to assess the percentage of patients alive at 6 months in elderly patients, not eligible to an platinum-based chemotherapy, but who can received the Tislelizumab treatment alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC). Tislelizumab is a monoclonal antibody administred by intravenous infusion This study aims to anwer too at the questions: * the Safety of the drug * Overall survival (OS) at 6 months according the diagnostic of PD-L1 expression (PD-L1 is a protein present on the surface of immune cells) * Overall response rate (ORR) according to imagery criteria * Progression-free survival (PFS) at 3 and 6 months according to imagery criteria and depending on PDL1 expression * Patients' health-related quality of life * OS and PFS according to geriatric parameters * Prognostic value of immune biomarkers

Phase:

PHASE2

Details

Lead Sponsor:

University Hospital, Clermont-Ferrand

Collaborators:

BeiGene USA, Inc.
Federation Francophone de Cancerologie Digestive