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NOT YET RECRUITING
NCT07629817
PHASE3

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

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.

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

2026-06-05

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