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NCT05023928 Clinical Trial

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

Carcinoma Clinical Trial

Official title:
Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05023928
Other study ID # ESOC2108
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2023

Study information
Verified date August 2021
Source Sichuan University
Contact Zhen-Yu Ding, Prof
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-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date September 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Tumor antigen-sensitized DC vaccine
subcutaneous administration

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 Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 3 months after the last administration of cells
Secondary Disease-free Survival Number of participants with Disease-free Survival as assessed by RECIST1.1 through study completion, an average of 1 year
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