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

NCT ID: NCT05023928

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-10-30

Brief Summary

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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

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Conditions

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Carcinoma Esophagus Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tumor antigen-sensitized DC vaccine

Intervention Type BIOLOGICAL

subcutaneous administration

Interventions

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Tumor antigen-sensitized DC vaccine

subcutaneous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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Zhen-Yu Ding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhen-Yu Ding, Prof

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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CHANT-211

Identifier Type: -

Identifier Source: org_study_id

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