Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

NCT ID: NCT06602843

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Group Type EXPERIMENTAL

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Intervention Type PROCEDURE

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Comparator

chemoradiotherapy followed by surgery

Group Type ACTIVE_COMPARATOR

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Intervention Type PROCEDURE

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Interventions

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Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anhui provincial hospital

Hefei, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yuan He

Role: primary

+8618926243766

Other Identifiers

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2024-042

Identifier Type: -

Identifier Source: org_study_id

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