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

NCT07205731 | Recruiting Phase 2 DMC

• 1 other identifier: PHRC K 2023 JARY
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 30

Brief 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

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

digestive oncology; immunotherapy; microenvironment biomarker; oncology; oncogeriatric domain; Ederly patients; chemotherapy

Outcome Measures

Primary Outcomes (1)

• To assess the percentage of patients alive at 6 months in elderly patients, not eligible to platinum-based chemotherapy, treated by anti-PD1 Tislelizumab alone as first-line treatment for an advanced ESCC

  to assess the rate of evaluable patients (i.e., those not lost to follow-up at 6 months and who have received at least one dose of the study treatment) who are alive at 6 months after inclusion to patient rate measurement

  6 month after inclusion

Secondary Outcomes (9)

• Safety according to NCI-CTCAE version 5.0

  time between the date of the first dose treatment with tislelizumab and the date within the 90 days after the last dose of treatment

• - Overall survival (OS) at 6 months depending on PD-L1 expression

  time between the date of the first dose treatment with tislelizumab and the date of death (whatever the cause) or date of last news for alive patients

• - Overall response rate (ORR) according to RECIST 1.1 criteria

  the time between the date of the first dose treatment with tislelizumab and the date of last dose of treatment

• Progression-free survival (PFS) at 3 and 6 months according to RECIST 1.1 criteria and depending on PDL1 expression

  at 3 month and 6 month after inclusion

• Patients' health according the questionnary quality of life C30 of EORTC

  time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment

Study Arms (1)

all patients receive the Tislelizumab on monotherapy

EXPERIMENTAL

Drug: Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1

Interventions

Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1 DRUG

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

all patients receive the Tislelizumab on monotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically proven esophageal squamous cell carcinoma (ESCC)
• Metastatic or locally advanced cancer
• Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
• Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician
• At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria
• Patients ≥ 70 years
• Subjects with WHO performance status ≤ 2
• Estimated life expectancy \>3 months
• Adjuvant therapy finished \>6 months
• Adequate marrow and organ functions defined as:
• Absolute neutrophil count (ANC) ≥ 1 × 109/L,
• Platelet count ≥ 75 × 109/L,
• Hemoglobin ≥ 90 g/L,
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN, or AST and ALT ≤5 ×ULN for patients with liver metastases
• ALP ≤ 5 x ULN unless liver metastases are present, in which case it must be ≤ 10x ULN

You may not qualify if:

• History of another primary malignancy. May be included, patients with:
• Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of treatment
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
• Participation in another clinical study with an investigational product during the last 2 months.
• Concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• History of allogenic organ, bone marrow, or double umbilical cord blood transplantation
• Active documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). May be included:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
• Any chronic skin condition that does not require systemic therapy.
• Patients with celiac disease controlled by diet alone
• Uncontrolled intercurrent illness; uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (recurrence ≤ 14 days after intervention). Patients with the following diseases are not excluded and may proceed to further screening:
• Controlled Type I diabetes

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• BeiGene USA, Inc.: collaborator
• Federation Francophone de Cancerologie Digestive: collaborator

Study Sites (30)

Centre Hospitalier Annecy Genevois

Annecy, Epagny Metz-Tessy, 74370, France

NOT YET RECRUITING

CHU Amiens

Amiens, France

NOT YET RECRUITING

Institut régional du cancer Provence d'Avignon

Avignon, France

NOT YET RECRUITING

Centre Hospitalier de la Côte Basque

Bayonne, 64100, France

NOT YET RECRUITING

CHU Besançon

Besançon, France

RECRUITING

CH Béthune et Beuvry

Beuvry, France

RECRUITING

ICHF Centre Pierre Curie

Beuvry, France

RECRUITING

CHRU Brest

Brest, France

RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

CHU Dijon

Dijon, France

NOT YET RECRUITING

Groupe Hospitalier Mutualiste

Grenoble, France

NOT YET RECRUITING

CHRU Lille

Lille, France

RECRUITING

CHU Limoges

Limoges, France

NOT YET RECRUITING

Centre Léon BERARD de Lyon

Lyon, France

NOT YET RECRUITING

CHU Nancy

Nancy, France

RECRUITING

Hôpital Européen Georges-Pompidou

Paris, France

RECRUITING

Hôpital Saint-Louis Lariboisière

Paris, France

RECRUITING

Le Groupe Hospitalier Diaconesses Croix Saint-Simon de Paris

Paris, France

RECRUITING

Centre hospitalier de Perpignan

Perpignan, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, France

RECRUITING

Centre Régional du Lutte Contre Le Cancer - Institut Godinot

Reims, 51726, France

NOT YET RECRUITING

CHU de Reims

Reims, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

RECRUITING

Groupe Hospitalier Rance Emeraude

St-Malo, France

RECRUITING

ICAN Strasbourg

Strasbourg, France

NOT YET RECRUITING

CHRU Tours

Tours, France

NOT YET RECRUITING

Médipôle Hôpital Mutualiste

Villeurbanne, France

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 3, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (30)