Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

NCT06602843 | Recruiting

• 1 other identifier: 2024-042
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell Carcinoma; Locally advanced; Chemoimmunotherapy; Radioimmunotherapy

Outcome Measures

Primary Outcomes (1)

• pCR

  Pathologic Complete Response

  immediately after the intervention/procedure/surgery

Secondary Outcomes (1)

• R0 resection rate

  immediately after the intervention/procedure/surgery

Other Outcomes (1)

• 1#3-year disease free survival

  immediately after the intervention/procedure/surgery

Study Arms (2)

Experimental

EXPERIMENTAL

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Comparator

ACTIVE COMPARATOR

chemoradiotherapy followed by surgery

Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Interventions

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy PROCEDURE

Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Comparator; Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui provincial hospital

Hefei, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-01

Locations

CN (1)