This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.
Has signed the written informed consent form and voluntarily participates in this study;
Aged 18-80 years, male or female;
Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;
Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;
Tumor invades adjacent organs of the esophageal lesion (major arteries or trachea);
Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
Poor nutritional status with BMI < 18.5 kg/m². Subjects whose nutritional status is corrected by symptomatic nutritional support prior to enrollment may be considered for inclusion upon assessment by the principal investigator;
History of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents;
Single group
Adebrelimab
DrugAdebrelimab: 1200 mg, intravenous infusion on Day 1, every 3 weeks (Q3W)
Thymalfasin
DrugThymalfasin: 1.6 mg, subcutaneous injection twice weekly for every 3-week cycle.
Chemotherapy
DrugNab-paclitaxel: 260 mg/m², intravenous infusion on Day 1, every 3 weeks (Q3W); Cisplatin: 75 mg/m², intravenous infusion on Day 1 / Day 2 / Day 3, every 3 weeks (Q3W); OR Carboplatin: AUC = 5-6, intravenous infusion on Day 1, every 3 weeks (Q3W).
Pathologic Complete Response (pCR) Rate
Defined as the proportion of subjects with Grade I pathological response per the pathological response evaluation criteria after neoadjuvant therapy, i.e., no residual viable tumor in the primary tumor lesion.
R0 Resection Rate
No residual viable tumor cells at the surgical resection margins
Major Pathologic Response （MPR）Rate
Defined as the percentage of subjects with ≤10% residual viable tumor (Grade I and Grade II pathological response).
Disease-Free Survival(DFS)
Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.
Objective Response Rate(ORR）
Defined as the proportion of subjects achieving complete response (CR) or partial response (PR) based on imaging assessments performed from study enrollment to prior to surgery, evaluated per RECIST version 1.1 criteria.
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