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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

NCT07205731 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-05-20

No results posted yet for this study

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)

Interventions

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

Sponsors & Collaborators

  • BeiGene USA, Inc.

    collaborator INDUSTRY

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2029-10-31
Completion
2030-10-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07205731 on ClinicalTrials.gov