Phase II Study of JS212 Combination Therapy for Advanced Esophageal Squamous Cell Carcinoma in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of a combination therapy called JS212 in patients with advanced esophageal squamous cell carcinoma ESCC that cannot be treated with radical therapy. This open-label, phase II clinical trial is conducted across multiple centers and sponsored by Shanghai Junshi Bioscience Co., Ltd. The study focuses on patients with locally advanced, recurrent, or metastatic ESCC. The study includes two experimental groups one receiving JS212 combined with JS001 every three weeks, and another receiving JS212, JS001 every three weeks plus 5-FU administered on days 1 and 8 of each three-week cycle. Treatments are given repeatedly according to these schedules to assess safety and response over time. The study does not use randomization or masking. Participants will be closely monitored for adverse events, dose-limiting toxicities, and objective tumor responses based on standard criteria over a period of up to four years. Researchers will also evaluate progression-free survival, overall survival, and immune response for up to two years. Patients must have measurable tumors and good performance status, and will undergo regular assessments to track their health and treatment effects throughout the study duration.

A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma