Clinical Trial

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

Study acronym: SAFE ESO
Recruiting Phase 2
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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
Protocol Amendment History 1 change
notable Trial sites expanded: 24 -> 28 locations 2026-04-15
Trial Details
NCT Number NCT07205731
Lead Sponsor University Hospital, Clermont-Ferrand
Collaborators: BeiGene USA, Inc., Federation Francophone de Cancerologie Digestive
Conditions Esophageal Squamous Cell Carcinoma (ESCC)
Enrollment 95 participants
Start Date 2025-10-07
Primary Completion 2029-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-20