This study includes patients with resectable esophageal squamous cell carcinoma who will undergo local radiotherapy (PTV: 1.5Gy Bid, for 5 days), followed by neoadjuvant treatment with Serplulimab combined with cisplatin and paclitaxel for three cycles. Afterward, they will undergo surgery. Postoperatively, researchers will select adjuvant treatment plans based on the patients' conditions.
Patients with histologically confirmed squamous cell carcinoma of the esophagus (ESCC) staged as cT1-2N+M0 and cT3NanyM0 (AJCC 8th edition);
Aged between 18-75 years;
ECOG performance status score of 0-1;
The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation
History of other malignancies in the past or concurrently, except for cured basal cell carcinoma of the skin and in situ cervical carcinoma; patients with small gastric stromal tumors and other tumors judged by the investigator to not affect the patient's life in the short term may be excluded;
Participation in other drug clinical trials within four weeks;
Patients with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that was completely resolved in childhood and does not require any intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators cannot be included);
Patients currently using immunosuppressants, or systemic corticosteroid therapy for immunosuppressive purposes (dose >10mg/day prednisone or other equivalent corticosteroids), and continued use within two weeks prior to enrollment;
Single group
Serplulimab
DrugSerplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles
pCR（Pathological Complete Response）
Definition of pathology complete response is "no cancer cell, including lympho nodes"
MPR（Major Pathological Remission rate）
The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline.
ORR（Objective Response Rate）
The Objective Response Rate (ORR) will be defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) (RECIST V1.1)
Rate of R0 resection
Measure the rate of R0 resection with all margins microscopically clear.
EFS (Events Free Survival)
The time from the start of treatment until any of the following events occur: any disease progression that prevents surgery, postoperative disease progression or recurrence, or death due to any cause
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This trial is not recruiting at the moment. You can still explore other options:
