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

March 8, 2025 updated by: Zhen-Yu Ding, Sichuan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Tumor antigen-sensitized DC vaccine
subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Time Frame: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
3 months after the last administration of cells

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: through study completion, an average of 1 year
Number of participants with Disease-free Survival as assessed by RECIST1.1
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Investigators

  • Principal Investigator: Zhen-Yu Ding, Prof, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANT-211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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