RecruitingPhase 3NCT05357846

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)


Sponsor

Sun Yat-sen University

Enrollment

422 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (a PD-1 inhibitor) to standard chemotherapy and radiation therapy before surgery can improve outcomes for people with locally advanced squamous cell cancer of the esophagus. **You may be eligible if...** - You have been diagnosed with squamous cell esophageal cancer that is potentially removable by surgery, at a specific stage (T1–4a with lymph node involvement, or T3–4a without) - You are between 18 and 70 years old - You have not received any prior cancer treatments - Your blood counts and organ function are within acceptable ranges - Your general health score (performance status) is 0 or 1 - Your expected survival is more than 6 months **You may NOT be eligible if...** - You have already received chemotherapy, radiation, or immunotherapy - You have distant cancer spread (metastatic disease) - Your blood counts or organ function are below required levels - You are unable to tolerate combined chemoradiation 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSintilimab

Sintilimab 200mg, IV (in the vein) on day 1 and day 22

RADIATIONPreoperative radiotherapy

External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

DRUGPaclitaxel

50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

DRUGCisplatin

25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

PROCEDUREesophagectomy

McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05357846


Related Trials