NCT07205731

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

PRODIGE 102 - FFCD 2201 - SAFE-ESO Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multicenter open-label single arm phase II study to evaluate Tislelizumab in monotherapy in frontline metastatic or locally advanced ESCC. Patient aged ≥70 years will be selected for inclusion after a diagnosis of metastatic or locally advanced ESCC, and if they are not eligible for a platinum-based chemotherapy regimen. Tislelizumab (200 mg flat dose every 3 weeks) will be received by intravenous perfusion until progression or unacceptable toxicity, for a maximum of 2 years. The patients will be included regardless of PD-L1 status; A comparison for all study population will be carried out centrally as part of the ancillary enquiries.

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Type	Name	Description
DRUG	Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1	It is the first study which evaluate efficacy and safety of anti PD-1 immune checkpoint inhibitor alone in the first-line treatment of elderly esophageal squamous-cell carcinoma patients who no fit to received chemotherapy with platine

Timeline

• Start date: 2025-10-07
• Primary completion: 2029-10-01
• Completion: 2030-10-01
• First posted: 2025-10-03
• Last updated: 2026-04-14

Locations

28 sites across 1 country: France