DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI

Summary

This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant chemo-immunotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2-3 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.

Timeline

Start

2025-11-03

Primary completion

2027-08-30

Completion

2030-08-30

Drugs

Indications