Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
NCT07629817 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1044
Last updated 2026-07-31
Summary
This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.
Conditions
Interventions
- DRUG
-
Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
- COMBINATION_PRODUCT
-
Radiation with Concurrent Chemotherapy
Chemotherapy administered concurrently with radiotherapy
- PROCEDURE
-
Radical Esophagectomy
Standard surgical procedure with lymph node dissection
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-16
- Primary Completion
- 2032-03-15
- Completion
- 2032-03-15
Countries
- China
Study Locations
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