About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Adebrelimab
- Thymalfasin
- Chemotherapy