Combining chemoradiation with Tislelizumab for advanced esophageal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label Phase 3 clinical trial investigates the efficacy of chemoradiation combined with Tislelizumab as a first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC) who have low PD-L1 expression. Participants will be randomly assigned to receive either chemoradiation or chemotherapy with Tislelizumab, with the primary goal of improving progression-free survival (PFS). The study focuses on patients who are not candidates for curative treatments and aims to provide insights into the effectiveness of this combination therapy in a specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition).
2. Subjects must have unresectable advanced, recurrent or metastatic ESCC.
3. Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery.
4. PD-L1 expression (CPS) is less than 10.
5. No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
6. ECOG Performance Status of 0 or 1.
7. Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization.
8. Subjects must have adequate organ and bone marrow function.

Exclusion Criteria:

1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
2. Active known or suspected autoimmune disease.
3. Any serious or uncontrolled medical disorder or active infection.
4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
5. Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.
6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Where it's running

• Renmin hosptial of Wuhan University
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Yongshun Chen, MD
• Email: yongshun2007@163.com
• Phone: +86 15327122084

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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• Tislelizumab plus chemotherapy for advanced gastric, gastroesophageal, and esophageal squamous cancers in U.S. racial and ethnic minority patients

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• Combining Tislelizumab and S-1 for Esophageal Cancer Treatment

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• Combining Tislelizumab with Chemotherapy for Esophageal Cancer Treatment

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.