Study of Cadonilimab with Paclitaxel Polymeric Micelles and Cisplatin as Pre-Surgery Treatment for Locally Advanced Esophageal Squamous Cell Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new neoadjuvant treatment combining Cadonilimab, a PD-1CTLA-4 bispecific antibody, with platinum-based chemotherapy Paclitaxel Polymeric Micelles for Injection and Cisplatin for patients with locally advanced esophageal squamous cell carcinoma. This Phase 2 clinical trial aims to measure pathologic complete remission rates after 2 to 4 treatment cycles, alongside other measures like objective remission rate, major pathologic remission rate, surgical removal rate, and 2-year survival outcomes. Participants receive Cadonilimab intravenously at 10 mgkg on day 3 every 3 weeks, combined with Paclitaxel Polymeric Micelles administered intravenously 230 mgm2 for cycle 1 possibly increased to 260 mgm2 for cycles 2-4 depending on blood counts and side effects and Cisplatin intravenously at 25 mgm2 daily for 3 days every 3 weeks. Treatment lasts approximately 12 weeks, covering 2 to 4 cycles before surgery. Throughout the study, participants undergo regular assessments including pathological evaluation after surgery to determine remission, as well as monitoring of overall and progression-free survival over 2 years. Safety and organ function are closely observed, with eligibility requiring adequate heart, liver, kidney, and blood function. Participants are followed from treatment initiation through surgery and beyond to evaluate clinical outcomes and side effects.

A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma