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Study on Tislelizumab for Elderly Patients with Advanced Esophageal Squamous Cell Carcinoma Unfit for Chemotherapy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called esophageal squamous cell carcinoma, which affects the esophagus, the tube that carries food from the mouth to the stomach. The study is specifically for elderly patients who are not able to undergo traditional chemotherapy treatments. The treatment being tested is a medication called Tislelizumab, also known by its code names BGB-A317 and JHL-2108. Tislelizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the safety and effectiveness of Tislelizumab in treating elderly patients with advanced esophageal squamous cell carcinoma who cannot receive standard chemotherapy. Participants in the study will receive Tislelizumab and will be monitored over a period of time to see how well they respond to the treatment. The study aims to assess how many patients are still alive six months after starting the treatment and to gather information on their overall health and quality of life during this period.

Throughout the study, researchers will also look at various factors such as the safety of the treatment, the overall survival of patients, and how the cancer responds to the medication. The study will also consider the expression of a protein called PD-L1, which may influence how well the treatment works. Additionally, the study will evaluate the quality of life of the patients and other health-related factors to provide a comprehensive understanding of the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study is focused on evaluating the safety and effectiveness of tislelizumab for elderly patients with advanced esophageal squamous-cell carcinoma who are not suitable for chemotherapy.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have a histologically proven squamous cell carcinoma of the esophagus, that the cancer is metastatic or locally advanced, and that you have not received previous treatment in the first-line setting. Your age should be 70 years or older, and your performance status should be 2 or less according to the World Health Organization (WHO) scale.

  3. Step 3

    Treatment administration

    You will receive tislelizumab through intravenous administration. The medication is provided as a solution for infusion, known as Tevimbra 100 mg concentrate. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Ongoing monitoring

    Throughout the study, your health will be closely monitored. This includes regular check-ups to assess the safety of the treatment and its effects on your condition. Your overall survival and response to the treatment will be evaluated at 6 months, and your quality of life will be assessed using specific health-related scales.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits will be scheduled to continue monitoring your health status. The primary goal is to assess the percentage of patients alive at 6 months after inclusion in the study.

Who can join the trial?

7 criteria

  • Must have a diagnosis of squamous cell carcinoma of the esophagus. This is a type of cancer that affects the esophagus, the tube that carries food from the mouth to the stomach.
  • The cancer must be metastatic (spread to other parts of the body) or locally advanced (grown into nearby structures).
  • Must not have received any previous treatment such as immunotherapy (treatment that uses the body's immune system to fight cancer), chemotherapy (use of drugs to kill cancer cells), or radiotherapy (use of high-energy rays to kill cancer cells) in the first line setting.
  • Must be considered ineligible for a platinum-based chemotherapy (a type of cancer treatment using drugs containing the metal platinum) as determined by an oncologist (cancer doctor) and a geriatrician (doctor specializing in care for older adults).
  • Must have at least one evaluable or measurable lesion as defined by RECIST v1.1 criteria. This means the cancer can be measured or evaluated using specific guidelines.
  • Must be 70 years or older.
  • Must have a WHO performance status of 2 or less. This is a scale that measures how well a person can perform ordinary tasks and carry out daily activities.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer besides squamous cell carcinoma of the esophagus cannot participate.
  • Patients who have not received at least one dose of the study treatment cannot participate.
  • Patients who are lost to follow-up, meaning they cannot be contacted or do not attend scheduled appointments, cannot participate.
  • Patients who are not alive at 6 months after inclusion cannot participate.
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Investigated drugs

Tislelizumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells. In this trial, Tislelizumab is being tested to see if it can help elderly patients with advanced esophageal squamous-cell carcinoma who are not able to undergo traditional chemotherapy. The goal is to determine if this medication can improve survival rates and provide a treatment option for those who cannot tolerate more aggressive therapies.

What is already known about the treatment

Tislelizumab – Tislelizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced esophageal squamous cell carcinoma, particularly in elderly patients who cannot undergo chemotherapy. The main therapeutic use of Tislelizumab is to help the immune system fight cancer cells. At the molecular level, it works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. Tislelizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and destroy cancer cells.

Investigated diseases

Squamous cell carcinoma of the esophagus – This is a type of cancer that begins in the flat cells lining the esophagus, which is the tube that carries food from the throat to the stomach. It typically starts in the upper and middle parts of the esophagus. As the disease progresses, it can cause difficulty swallowing, weight loss, and chest pain. The cancer may grow deeper into the esophageal wall and spread to nearby lymph nodes and other organs. Over time, it can lead to narrowing of the esophagus, making it hard to swallow solid foods. The disease can also cause a persistent cough and hoarseness.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518358-17-00Protocol codePHRC K 2023 JARYEstimated enrolment95 patientsSponsorUniversity Hospital Of Clermont-Ferrand

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