Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy for Patients Aged 18 to 75 With Resectable Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating Toripalimab combined with sequential neoadjuvant chemoradiotherapy in patients with resectable local middle and advanced esophageal squamous cell carcinoma. This open phase II clinical study involves 34 patients and aims to assess the effectiveness and safety of this combination treatment by looking at pathological complete response, disease-free survival, overall survival, and adverse reactions. The treatment begins with Phase I, where patients receive Toripalimab 240mg on day 1 every 3 weeks for 2 cycles combined with a chemotherapy regimen chosen by the investigator. In the second stage, patients receive Toripalimab 240mg on day 1, every 3 weeks for 1 cycle combined with intensity modulated radiotherapy 40Gy delivered in 20 fractions. Surgery is then performed 4 to 6 weeks after completing the treatments, followed by multidisciplinary team discussions to decide on further therapy. Participants will undergo assessments including pathological evaluation of tumor response after surgery to determine complete and major pathological responses. Researchers will monitor disease-free and overall survival for up to 100 and 120 months respectively, and record adverse events during treatment and an average two-year follow-up. Vital organ functions, imaging, and laboratory tests are used to ensure safety and treatment adherence throughout the study period.

A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma