Phase II Study of Chemotherapy and Pembrolizumab Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma Comparing 2 to 4 Cycles Alone or With Radiotherapy to Improve Treatment Outcomes

What this Trial Is About

Researchers are investigating the best neoadjuvant treatment plans for adults with locally advanced esophageal squamous cell carcinoma, a type of esophageal cancer without distant metastasis. Previous studies showed that combining chemotherapy with immunotherapy before surgery led to higher rates of tumor response and was generally safe. This trial aims to explore whether extending immunotherapy cycles and adding radiotherapy can improve outcomes further. Participants will be randomly assigned to one of three groups two cycles of chemoimmunotherapy followed by surgery, four cycles of chemoimmunotherapy followed by surgery, or four cycles of chemoimmunotherapy plus radiotherapy before surgery. Chemotherapy includes carboplatin and nab-paclitaxel, and immunotherapy uses pembrolizumab. Radiotherapy, when used, is given at 40-45 Gy over 20 sessions, five times a week. During the study, participants will undergo surgery after their assigned neoadjuvant treatment. Researchers will assess pathological response after surgery and monitor survival rates at two and five years. They will also track adverse effects, surgical complications, and disease-free survival. The trial includes long-term follow-up to evaluate the safety and effectiveness of these treatment regimens over time.

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma