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

This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.

NCT Number	NCT06843889
Lead Sponsor	Nanfang Hospital, Southern Medical University
Conditions	Locally Advanced Esophageal Squamous Cell Carcinoma
Enrollment	34 participants
Start Date	2025-04-03
Primary Completion	2027-08-01 (estimated)
Study Completion	2028-08-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-16