Back to resultsTumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
Primary Purpose
Carcinoma, Esophagus Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tumor antigen-sensitized DC vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring esophagus cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
Eligibility Criteria
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
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tumor antigen-sensitized DC vaccine
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Disease-free Survival
Number of participants with Disease-free Survival as assessed by RECIST1.1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05023928
Brief Title
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
Official Title
Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Esophagus Cancer
Keywords
esophagus cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tumor antigen-sensitized DC vaccine
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Tumor antigen-sensitized DC vaccine
Intervention Description
subcutaneous administration
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Time Frame
3 months after the last administration of cells
Secondary Outcome Measure Information:
Title
Disease-free Survival
Description
Number of participants with Disease-free Survival as assessed by RECIST1.1
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen-Yu Ding, Prof
Email
dingzhenyu@scu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen-Yu Ding, Prof
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen-Yu Ding, Prof
Phone
0086288542357
Email
dingzhenyu@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
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