This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.
Patients voluntarily participate in this study, sign an informed consent form, and demonstrate good compliance;
At least 18 years of age; gender is not restricted;
ECOG performance status: 0-1;
Patients with histologically confirmed resectable esophageal squamous cell carcinoma clinically staged as (T1N+M0 or T2-4aNanyM0);
Concurrent malignant neoplasms (except for cured basal cell carcinoma of the skin);
Diagnosis of cervical esophageal cancer;
History of severe hypersensitivity reactions following administration of other monoclonal antibodies;
Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, or nephritis; asthma requiring bronchodilators for medical intervention); however, the following patients are eligible for enrollment: vitiligo, psoriasis, or alopecia not requiring systemic treatment; well-controlled type 1 diabetes; hypothyroidism with normal thyroid function following replacement therapy;
Parallel
Combination therapy with chemotherapy and immunotherapy
DrugAdebrelimab Injection，intravenous infusion, Day 1, every 3 weeks for 2 cycles. Albumin-bound paclitaxel 260 mg/m², carboplatin AUC = 5, intravenous infusion, Day 1, every 3 weeks for 2 cycles. Two cycles of chemotherapy combined with immunotherapy.
Surgery
Other interventionsurgery
2-year Disease-Free Survival (DFS) rate in the watchful waiting arm
2-year Overall Survival (OS) in the watchful waiting arm
2-year OS in the surgery arm
R0 resection rate
Pathological Complete Response (pCR) rate
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