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NCT Number: NCT06602843

Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Procedure

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Primary outcomes

  1. pCR

    Time frame: immediately after the intervention/procedure/surgery

    Pathologic Complete Response

Secondary outcomes

  1. R0 resection rate

    Time frame: immediately after the intervention/procedure/surgery

    R0 resection rate

Other outcomes

  1. 1#3-year disease free survival

    Time frame: immediately after the intervention/procedure/surgery

    1#3-year disease free survival

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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