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Recruiting NCT06602843

Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

No phase Interventional Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Procedure Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
    Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Primary outcome measures

  • pCR [Time frame: immediately after the intervention/procedure/surgery]
Secondary outcome measures (1)
  • R0 resection rate [Time frame: immediately after the intervention/procedure/surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Anhui provincial hospital — Hefei

Identifiers

NCT: NCT06602843 · 2024-042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗