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NCT05317325 Clinical Trial

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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05317325
Other study ID # HXDB-2203
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2022
Est. completion date April 1, 2024

Study information
Verified date March 2022
Source Sichuan University
Contact Zhen-Yu Ding, Prof
Phone 0086288542357
Email dingzhenyu@scu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date April 1, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of treatment-related adverse events Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 From the first administration of vaccine to 3 months after the last administration
Secondary Disease-free Survival Number of participants with Disease-free Survival as assessed by RECIST1.1 from the study start to 1 year after the study completion
See also
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