Sintilimab as Follow-Up Treatment After Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of sintilimab as a consolidation therapy in elderly patients aged 70 to 85 years with esophageal squamous cell carcinoma who did not experience disease progression after receiving concurrent chemoradiotherapy. This phase II, prospective, randomized, controlled, multicenter study aims to compare progression-free survival, overall survival, tumor response, toxicity, and quality of life between treatment groups. The study is sponsored by Zhejiang Cancer Hospital and focuses on patients who cannot tolerate or refuse surgery. Participants are divided into two groups based on minimal residual disease MRD status and randomized to receive either sintilimab or regular follow-up observation. Patients in the treatment group receive sintilimab intravenously every three weeks, with dosing based on weight 3 mgkg for those weighing less than 60 kg and 200 mg for those 60 kg or more. Treatment starts within 42 days after the last radiotherapy session and continues until disease progression, unacceptable toxicity, loss to follow-up, death, or investigator decision, with a maximum duration of 12 months. The observation group undergoes regular follow-up every three months for at least one year without additional anti-tumor treatments. During the study, participants will undergo regular assessments including monitoring for disease progression, survival status, tumor response, and side effects. The primary outcome measure is median progression-free survival. Secondary outcomes include overall survival, objective response rate, and duration of response, with follow-up planned for up to two years. Safety and quality of life will be evaluated throughout, and no other cancer treatments are allowed during the study period. Total participation duration varies depending on treatment response and follow-up.

Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma