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

Sichuan University

Status and phase: Unknown; Phase 1

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Biological: OCDC vaccine; NeoDC vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05317325

HXDB-2203

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental Group

Experimental group

Description:

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.

Treatment:

Biological: OCDC vaccine; NeoDC vaccine