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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
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites revised (30)v11
  2. Study sites: 29 to 30v10
  3. Trial sites expanded: 24 → 28 locationsv9
  4. Study sites: 24 to 28v8
  5. Study sites: 23 to 24v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 22 to 23v6
  2. Study sites: 20 to 22v5
  3. Study sites: 19 to 20v4
  4. Study sites: 15 to 19v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 10 to 15
    • Start date changed from estimate of Oct 2025 to Oct 7, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07205731
Lead Sponsor University Hospital, Clermont-Ferrand
Collaborators: BeiGene USA, Inc., Federation Francophone de Cancerologie Digestive
Conditions
(from sponsor)		 Esophageal Squamous Cell Carcinoma (ESCC)
Related terms Esophageal Squamous Cell Carcinoma, Neoplasms
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov