Back to resultsA Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
OCDC vaccine; NeoDC vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal cancer, tumour cell lysate, neoantigen, prime-boost, dendritic cell vaccine
Eligibility Criteria
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
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Group
Arm 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.
Outcomes
Primary Outcome Measures
The number of treatment-related adverse events
Number of participants with treatment-related adverse 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
NCT05317325
Brief Title
A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC
Official Title
A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (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-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal cancer, tumour cell lysate, neoantigen, prime-boost, dendritic cell vaccine
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
Experimental Group
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
OCDC vaccine; NeoDC vaccine
Intervention Description
OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.
Primary Outcome Measure Information:
Title
The number of treatment-related adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
From the first administration of vaccine to 3 months after the last administration
Secondary Outcome Measure Information:
Title
Disease-free Survival
Description
Number of participants with Disease-free Survival as assessed by RECIST1.1
Time Frame
from the study start to 1 year after the study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen-Yu Ding, Prof
Phone
0086288542357
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
dignzhenyu@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC
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