Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer

Sichuan University1 site in 1 country25 target enrollmentSeptember 1, 2021

ConditionsCarcinoma Esophagus Cancer

InterventionsTumor antigen-sensitized DC vaccine

DrugsTumor antigen-sensitized DC vaccine

Overview

Phase: Phase 1
Intervention: Tumor antigen-sensitized DC vaccine
Conditions: Carcinoma
Sponsor: Sichuan University
Enrollment: 25
Locations: 1
Primary Endpoint: Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2021

End Date

October 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan University

Responsible Party

Principal Investigator

Zhen-Yu Ding

Professor

Sichuan University

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Tumor antigen-sensitized DC vaccine