Comparing Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib with Immunotherapy and Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

This research aims to evaluate the safety and effectiveness of two different preoperative treatments for patients with locally advanced esophageal squamous cell carcinoma. It compares neoadjuvant immunotherapy combined with chemotherapy and anlotinib to immunotherapy combined with concurrent chemoradiotherapy. The study is a single-center, open-label, randomized controlled trial designed to find the best preoperative treatment approach for this type of esophageal cancer. Participants will receive one of two treatment regimens before surgery. One group receives camrelizumab, chemotherapy drugs carboplatin, cisplatin, paclitaxel or nab-paclitaxel, and oral anlotinib over two 3-week cycles. The other group receives camrelizumab, chemotherapy drugs, and thoracic radiotherapy given daily over about 4.6 weeks during the same period. Both treatments are given before surgery to shrink the tumor. During the study, participants will be monitored for pathological response up to approximately 15 weeks after randomization. Researchers will assess tumor response using pathological complete response and major pathological response measures. Secondary outcomes include objective response rate, 3-year disease-free survival, R0 excision rate, and overall survival. The study lasts up to about 3 years after surgery to track long-term outcomes and safety.

A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma