Tumor Antigen-sensitized DC Vaccine As an Adjuvant Therapy for Esophagus Cancer

Phase 1

Completed

• Conditions: Carcinoma; Esophagus Cancer
• Interventions: Biological: Tumor antigen-sensitized DC vaccine

• Registration Number: NCT05023928
• Lead Sponsor: Sichuan University

Brief Summary

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-21
• Study First Posted: 2021-08-27
• Study Start: 2021-09-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-08
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Pathologically confirmed diagnosis of esophageal squamous cell carcinoma；
• Immunotherapy for preoperative；
• Karnofsky performance status 0-1;
• The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th
• Function of the main organs is normal;
• Edition Patient's written informed consent

Exclusion Criteria

• Tumor emergencies;
• Abnormal coagulation function;
• Contagious diseases, such as HIV, HBV, HCV infection;
• Mental disorders;
• Concomitant tumors;
• Immunological co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor antigen-sensitized DC vaccine	Tumor antigen-sensitized DC vaccine	Tumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times. 2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0	3 months after the last administration of cells	Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival	through study completion, an average of 1 year	Number of participants with Disease-free Survival as assessed by RECIST1.1

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China