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

Sichuan University

Status and phase: Completed; Phase 1

Conditions: Esophagus Cancer; Carcinoma

Treatments: Biological: Tumor antigen-sensitized DC vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05023928

CHANT-211

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Tumor antigen-sensitized DC vaccine

Experimental group

Description:

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.

Treatment:

Biological: Tumor antigen-sensitized DC vaccine