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.
1: age 18-75 years old, both sexes; 2: esophageal squamous cell carcinoma confirmed by histopathology; 3: T2-4a, N0-3, M0 (AJCC 8th edition) thoracic esophageal cancer patients, resectable by surgical evaluation; 4: initial treatment patients without anti-tumor therapy; 5: expected survival time ≥6 months; 6: ECOG ≤1; 7: There was no history of esophageal perforation, active esophageal bleeding, and no obvious invasion of trachea or thoracic large vessels.
1: known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components; 2: currently participating in and receiving other study treatment; 3: previous systemic therapy for esophageal cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc.
Single group
Toripalimab (240mg day1, Q3W*3cycle)
DrugPhase 1: Toripalimab (240mg day1, Q3W\*2cycle) + investigator's choice of clinical conventional chemotherapy; Phase 2: 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.
Pathological Complete Response Rate (pCR)
The absence of residual viable tumor cells in both the primary esophageal tumor and regional lymph nodes after completion of neoadjuvant chemoradiotherapy and surgery, indicating a complete pathological response.
Major Pathological Response Rate (MPR)
A significant reduction in tumor burden, defined as less than 10% residual viable tumor in the surgical specimen following neoadjuvant chemoradiotherapy, reflecting a near-complete response.
Disease-Free Survival (DFS)
The duration from the date of surgery to the first occurrence of disease recurrence, metastasis, or death from any cause, measuring the effectiveness of the treatment in preventing disease progression.
Overall Survival (OS)
The length of time from the start of neoadjuvant treatment until death from any cause, evaluating the long-term survival benefit of the combined therapy.
Adverse Events (AEs)
Any unfavorable or unintended medical occurrences, including clinical signs, symptoms, or laboratory abnormalities, observed in patients receiving toripalimab combined with neoadjuvant chemoradiotherapy, regardless of causality.
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