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Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

U

University of Science and Technology of China (USTC)

Status

Enrolling

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06602843
2024-042

Details and patient eligibility

About

The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma

Enrollment

70 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ages 18-75;
  • Radical operation for esophageal cancer;
  • Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
  • More than or equal to 12 lymph nodes were surgically removed;
  • Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
  • Informed consent signed by patient or family member.

Exclusion criteria

  • Less than 18 years old, more than 75 years old;
  • did not receive radical resection of esophageal cancer, including palliative resection;
  • Postoperative pathology showed non-esophageal squamous cell carcinoma;
  • After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
  • Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
  • The patient or family member did not sign the informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

70 participants in 2 patient groups

Experimental
Experimental group
Description:
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Treatment:
Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Comparator
Active Comparator group
Description:
chemoradiotherapy followed by surgery
Treatment:
Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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