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

NCT05357846 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2026-04-30

No results posted yet for this study

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

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.

DRUG

Sintilimab

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

Sponsors & Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • HONG YANG · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2031-01-01
Completion
2031-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357846 on ClinicalTrials.gov