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RECRUITING
NCT05357846
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

422

Start Date

2022-11-01

Completion Date

2031-01-31

Last Updated

2025-06-12

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

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

RADIATION

Preoperative radiotherapy

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

DRUG

Paclitaxel

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

DRUG

Cisplatin

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

PROCEDURE

esophagectomy

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