Adebrelimab Combined With Neoadjuvant Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: A Single-Arm Exploratory Clinical Study

What this Trial Is About

Researchers are exploring the use of adebrelimab combined with platinum-based chemotherapy as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). This phase II, single-arm study aims to evaluate the pathological complete response (pCR) rate after surgery and assess the safety of this treatment approach. The study is motivated by the need for more effective and well-tolerated therapies, as current standard treatments have limitations including higher recurrence and surgical complexity. Participants will receive at least two cycles of neoadjuvant therapy every three weeks, consisting of intravenous adebrelimab at 20 mg/kg on day 1, combined with chemotherapy drugs given on day 2. Chemotherapy includes either cisplatin or carboplatin along with liposomal paclitaxel or nab-paclitaxel. All patients undergo surgery following neoadjuvant treatment. The trial also plans to develop organoids from tumor and normal tissue for future research. During the study, patients will be monitored for pathological response, safety including treatment-related and immune-related adverse events, and quality of life. Secondary outcomes include major pathological response, objective response rate, tumor downstaging, surgery success, and perioperative complications. Exploratory endpoints include overall and relapse-free survival. The study involves detailed pathological evaluations at the end of 2 to 4 treatment cycles and aims for comprehensive assessment of treatment impact over the course of neoadjuvant therapy and surgery.

Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma