Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-09-01; most recent amendment 2026-05-26.
Trial Details
NCT Number NCT07162506
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Collaborators: Shanxi Province Cancer Hospital, Sichuan Province Cancer Hospital, Henan Province Cancer Hospital
Conditions Esophageal Cancer
Enrollment 120 participants
Start Date 2025-11-03
Primary Completion 2027-08-30 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-29