Comparing Chemoradiation Plus Tislelizumab Versus Chemotherapy Plus Tislelizumab as First Treatment for Advanced Esophageal Squamous Cell Carcinoma with Low PD-L1

What this Trial Is About

Researchers are evaluating treatment options for patients with advanced esophageal squamous cell carcinoma ESCC who have low PD-L1 expression and have not received prior systemic therapy for their advanced or metastatic disease. This multicenter, randomized, open-label phase 3 clinical trial compares two treatment approaches to determine which better improves progression-free survival PFS. The study focuses on patients with unresectable, locally advanced, recurrent, or metastatic ESCC who are not candidates for curative treatments like surgery or definitive chemoradiation. Participants are randomly assigned to one of two groups. The first group receives chemoradiation combined with Tislelizumab, including intensity-modulated radiotherapy IMRT targeting tumors at specified doses, alongside Tislelizumab and chemotherapy drugs Nab Paclitaxel and Cisplatin administered on specific schedules during concurrent radiation and consolidation therapy. The second group receives chemotherapy combined with Tislelizumab without radiation. Treatment cycles and dosing vary between the groups, with Tislelizumab given intravenously every three weeks. During the study, participants undergo regular imaging assessments such as CT or MRI scans to measure tumor response according to RECIST criteria. Researchers monitor progression-free survival as the primary outcome over approximately 40 months from the first participants randomization. Secondary outcomes include overall survival, objective response rate, duration of response, and adverse events. The study includes safety monitoring and evaluates treatment effects over the planned timeline, with ongoing assessments throughout the trial period.

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