A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma

Recruiting now · Phase 3

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.

Key facts

Study ID

NCT05919030

Run by

Renmin Hospital of Wuhan University

People needed

155

Starts

2023-07-01

Expected to finish

2027-07-01

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition).
• Subjects must have unresectable advanced, recurrent or metastatic ESCC.
• Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery.
• PD-L1 expression (CPS) is less than 10.
• No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
• ECOG Performance Status of 0 or 1.
• 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.
• Subjects must have adequate organ and bone marrow function.

You may not qualify if…

• Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
• Active known or suspected autoimmune disease.
• Any serious or uncontrolled medical disorder or active infection.
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.
• 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 is running

• Renmin hosptial of Wuhan University — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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