Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

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: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hefei, China
    • Recruiting
    • Anhui Provincial Hospital
    • Contact: Yuan He; Phone Number: +8618926243766; Email: heyuan3766@126.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Pathologic Complete Response	immediately after the intervention/procedure/surgery

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

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: Radioimmunotherapy; Esophageal Squamous Cell Carcinoma; Locally advanced; Chemoimmunotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• 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