Chemoradiation Versus Chemotherapy in Combination with Tislelizumab As First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma with Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial
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.
• 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.