drugset / Trial / NCT04280822

Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma

NCT04280822

Phase 3 Recruiting 400 enrolled Henan Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.

Timeline

Start
2020-04-21
Primary completion
2023-12-02
Completion
2028-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2
Background Paclitaxel Small molecule 175 mg/m2

Indications