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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hôpital Européen Georges-Pompidou Paris France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Institut Godinot Reims France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Bethune Beuvry Beuvry France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier De La Cote Basque Bayonne France
Scp Institut De Cancerologie Des Hauts De France Beuvry France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Institut Sainte Catherine Avignon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Groupe Hospitalier Rance Emeraude Saint-Malo France
Clitat Ldfc Buwdhs Lyon France
Cjgqeq Hiogdhybohh Uwljdfxqzjlgd Rmjae Reims France
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Csynmj Hbiihtgbzxh Ubjyzmwenyyxb Do Dzqvs Dijon France
Agvzbeeafm Pwthhajm Hmqhlkfl Do Pkfgi Paris France
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Cqddiv Hfusikjcqyz Rkgkprzh Uqerzmuvmkfjl Do Tsrjz Tours France
Cooy Du Nfjch Vandoeuvre Les Nancy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.02.2025

Trial locations

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.

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 ID:
2024-518358-17-00
Protocol code:
PHRC K 2023 JARY
Trial Phase:
Therapeutic exploratory (Phase II)

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