Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

September 15, 2024 updated by: Anhui Provincial Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hefei, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Active Comparator: Comparator
chemoradiotherapy followed by surgery
Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR
Time Frame: immediately after the intervention/procedure/surgery
Pathologic Complete Response
immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: immediately after the intervention/procedure/surgery
R0 resection rate
immediately after the intervention/procedure/surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
1#3-year disease free survival
Time Frame: immediately after the intervention/procedure/surgery
1#3-year disease free survival
immediately after the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 8, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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