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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Phase 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.
Nanfang Hospital, Southern Medical University
Guangzhou, Baiyun District, China
RECRUITINGPathological 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.
Time frame: Perioperative
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.
Time frame: Perioperative
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.
Time frame: From the date of surgery (or completion of treatment) to the date of the first documented disease recurrence, metastasis, or death from any cause, whichever occurred first,assessed up to 100 months.
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.
Time frame: From the date of treatment initiation (or diagnosis) to the date of death from any cause,assessed up to 120 months..
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.
Time frame: Monitored throughout the treatment period and during follow-up, an average of 2 years.
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