NCT05357846

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Esophageal Carcinoma
• Esophageal Cancer
• Oesophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2031-01-01
• Completion: 2031-01-31
• First posted: 2022-05-03
• Last updated: 2025-06-12

Locations

1 site across 1 country: China