RecruitingPhase 2NCT07205731

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

95 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immunotherapy drug called tislelizumab as a first-line treatment for elderly patients with advanced esophageal squamous cell carcinoma who are too frail or medically unfit to receive standard chemotherapy. The goal is to offer an effective alternative to those who cannot tolerate traditional treatment. **You may be eligible if...** - You are 70 or older with confirmed esophageal squamous cell cancer that is advanced or has spread - You have not received any prior treatment (no immunotherapy, chemotherapy, or radiation) for this cancer in the first-line setting - Your oncologist and a geriatrics specialist have determined you are not suitable for platinum-based chemotherapy - You have at least one measurable or assessable tumor - Your overall health is rated as adequate (WHO performance status 0–2) - You are expected to live more than 3 months - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have already received treatment for this stage of cancer - You are fit enough for standard platinum-based chemotherapy - You have active autoimmune disease or are taking systemic steroids - You have untreated brain metastases - Your blood counts or organ function do not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab 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


Locations(30)

Centre Hospitalier Annecy Genevois

Annecy, Epagny Metz-Tessy, France

CHU Amiens

Amiens, France

Institut régional du cancer Provence d'Avignon

Avignon, France

Centre Hospitalier de la Côte Basque

Bayonne, France

CHU Besançon

Besançon, France

CH Béthune et Beuvry

Beuvry, France

ICHF Centre Pierre Curie

Beuvry, France

CHRU Brest

Brest, France

Centre François Baclesse

Caen, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Dijon

Dijon, France

Groupe Hospitalier Mutualiste

Grenoble, France

CHRU Lille

Lille, France

CHU Limoges

Limoges, France

Centre Léon BERARD de Lyon

Lyon, France

CHU Nancy

Nancy, France

Hôpital Européen Georges-Pompidou

Paris, France

Hôpital Saint-Louis Lariboisière

Paris, France

Le Groupe Hospitalier Diaconesses Croix Saint-Simon de Paris

Paris, France

Centre hospitalier de Perpignan

Perpignan, France

CHU Poitiers

Poitiers, France

Centre Régional du Lutte Contre Le Cancer - Institut Godinot

Reims, France

CHU de Reims

Reims, France

CHU Rennes

Rennes, France

CHU Rouen

Rouen, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Groupe Hospitalier Rance Emeraude

St-Malo, France

ICAN Strasbourg

Strasbourg, France

CHRU Tours

Tours, France

Médipôle Hôpital Mutualiste

Villeurbanne, France

View Full Details on ClinicalTrials.gov

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NCT07205731


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