About this trial
This is a domestic exploratory, single-arm clinical study enrolling patients with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), aiming to evaluate the efficacy and safety of neoadjuvant adebrelimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provided written informed consent and voluntarily enrolled in this study;
Aged 18-75 years, male or female;
Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC);
Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;
Disqualifiers
Significant tumor invasion into adjacent organs of the esophageal lesion (e.g., major arteries or trachea);
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Poor nutritional status with a Body Mass Index <18.5 kg/m² (BMI <18.5 kg/m²); subjects whose BMI is corrected with targeted nutritional support prior to randomization may be considered for enrollment at the discretion of the principal investigator;
History of hypersensitivity to monoclonal antibodies, any component of adebrelimab, paclitaxel, cisplatin, or other platinum-based agents;
Trial design
Single group
Treatments tested in this trial
Adebrelimab
DrugAdebrelimab 1200 mg or 20 mg/kg, intravenous infusion, every 3 weeks (Q3W);
chemotherapy
Drugnanoparticle albumin-bound paclitaxel (Nab-paclitaxel) 100 mg/m² on Days 1 and 8 (D1/D8), intravenous infusion, every 3 weeks (Q3W); Cisplatin 75 mg/m² on Days 1, 2 and 3 (D1/D2/D3), intravenous infusion, every 3 weeks (Q3W).
Treatment groups
Trial outcomes
Primary outcomes
Pathological Complete Response Rate (pCR)
Secondary outcomes
Surgical R0 resection rate
Main pathological relief (MPR)
Disease-Free Survival (DFS)
Objective Response Rate (ORR)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.