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

StatusRecruiting
PhasePhase 2
Started2025-04-03
View on ClinicalTrials.gov ↗

Amendment history

2025-04-11
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-01→confirmed 2025-04-03
InterventionsTriplelizumab (240mg day1, Q3W*2cycle) (Drug)→Toripalimab (240mg day1, Q3W*3cycle) (Drug)
Eligibility criteria-4 characters
[...] anti-tumor therapy; 5: expected survival time ≥6 months; 6: PS scoreECOG ≤21; 7: There was no history of esophageal perforation, active [...]
Study sitesdetails revised at 1 of 1 site
2025-02-23
Original filing
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.
Trial Details
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