Phase II Study of Sintilimab with Chemotherapy Followed by Chemoradiotherapy for Advanced Unresectable Esophageal Squamous Cell Carcinoma

What this Trial Is About

This clinical trial focuses on patients with locally advanced unresectable esophageal squamous cell carcinoma ESCC, specifically those who are treatment-nafve and have certain stages of the disease including cT4bN-M0 andor cTanyNM0, which may involve extracapsular invasion of mediastinal lymph nodes. The study is a phase II, single-arm trial evaluating the effectiveness and safety of combining sintilimab with chemotherapy followed by sequential concurrent chemoradiotherapy as a conversion therapy approach for this patient group. Participants will first receive two cycles of sintilimab combined with liposomal paclitaxel and cisplatin chemotherapy. After this, an evaluation will determine if surgery is possible. If surgery is feasible, patients undergo resection followed by up to one year of adjuvant sintilimab, with possible postoperative radiotherapy as decided by the investigator. Patients ineligible for surgery will receive concurrent chemoradiotherapy with a total radiation dose of 5040cGy in 28 fractions, after which a second surgical evaluation is done. Those then eligible for surgery will have resection and continue sintilimab, while those remaining ineligible will continue sintilimab treatment after chemoradiotherapy. During the study, participants will have regular assessments including imaging and clinical evaluations to monitor treatment response and safety. Researchers will measure outcomes such as the 2-year overall survival rate, resection rates, pathological complete response, major pathological response, event-free survival, and surgical conversion rates. Participants will be followed for up to 24 months to evaluate these outcomes and monitor any treatment-related effects or adverse events throughout the study period.

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)