Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

Not Applicable

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

• Registration Number: NCT06602843
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy	Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Comparator	Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy	chemoradiotherapy followed by surgery

Primary Outcome Measures

Name	Time	Method
pCR	immediately after the intervention/procedure/surgery	Pathologic Complete Response

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	immediately after the intervention/procedure/surgery	R0 resection rate

Trial Locations

Locations (1)

Anhui provincial hospital; 🇨🇳 Hefei, China