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NOT YET RECRUITING
NCT07629817
PHASE3

Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1044

Start Date

2026-06-15

Completion Date

2032-03-15

Last Updated

2026-06-10

Healthy Volunteers

No

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