RecruitingPhase 3NCT04280822

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

A Phase III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in Combination With Chemotherapy Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Sponsor

Henan Cancer Hospital

Enrollment

400 participants

Start Date

Apr 21, 2020

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Surgery Neoadjuvant Treatment Survival

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two pre-surgery treatment approaches for esophageal cancer (cancer of the food pipe). One group receives chemotherapy combined with immunotherapy before surgery; the other receives chemotherapy only. The goal is to see if adding immunotherapy improves outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced squamous cell esophageal cancer confirmed by biopsy - You have not had any previous treatment for this cancer - Your blood counts and organ function are adequate - You are healthy enough to have surgery **You may NOT be eligible if...** - You have cancerous lymph nodes in the neck area (detected by ultrasound) - Your cancer has spread to distant organs - You have previously received treatment for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant immunochemotherapy

Neo-adjuvant chemotherapy(cisplatin and paclitaxel): Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. JS001, 240mg ivgtt, d3, \>30min, 3week, 2 cycles Surgery: 2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included). After surgery/ maintain period: JS001, 240mg ivgtt, d3, \>30min, 3week (8 cycles at most)