A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-04-01

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-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

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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Experimental Group

Autologous DCs pulsed with HOCl-oxidized autologous tumor lysate (OCDC) vaccine is administered in prime phase and personal neoantigen-sensitized DC(NeoDC) vaccine is administered in boost phase.

Group Type EXPERIMENTAL

OCDC vaccine; NeoDC vaccine

Intervention Type BIOLOGICAL

OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.

Interventions

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OCDC vaccine; NeoDC vaccine

OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed diagnosis of esophageal squamous cell carcinoma
* no preoperative adjuvant therapy
* Karnofsky performance status 0-2;
* The postoperative pathological stage is pT2-4 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

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No