Back to resultsPersonalized DC Vaccine for Postoperative Cancer
Primary Purpose
Gastric Cancer, Hepatocellular Carcinoma, Non-Small-Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC vaccine subcutaneous administration
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Cell therapy, safety, clinical efficacy, adjuvant treatment, locally advanced cancer
Eligibility Criteria
Inclusion Criteria:
- Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
- Anticipated life time > 3month
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Adequate organ functions
Exclusion Criteria:
- Any evidence of tumor metastasis or co-existing malignant disease
- Tumor emergency
- Abnormal coagulation condition
- Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- Concomitant tumors
- Immunological co-morbidities
Sites / Locations
- Qiu LiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cell_therapy
Arm Description
tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times
Outcomes
Primary Outcome Measures
Disease-free Survival (DFS)
Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first
Secondary Outcome Measures
Overall Survival (OS)
Defined by the time between the date of randomization and the date of death
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Defined by treatment-related adverse events as assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04147078
Brief Title
Personalized DC Vaccine for Postoperative Cancer
Official Title
Adjuvant Treatment in Cancer Patients With Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 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 study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.
Detailed Description
Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Hepatocellular Carcinoma, Non-Small-Cell Lung Cancer, Colon Rectal Cancer
Keywords
Cell therapy, safety, clinical efficacy, adjuvant treatment, locally advanced cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cell_therapy
Arm Type
Experimental
Arm Description
tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times
Intervention Type
Biological
Intervention Name(s)
DC vaccine subcutaneous administration
Intervention Description
subcutaneous administration
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS)
Description
Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Defined by the time between the date of randomization and the date of death
Time Frame
Up to 10 years
Title
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Description
Defined by treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
3 months after the last administration of cells
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
Anticipated life time > 3month
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Adequate organ functions
Exclusion Criteria:
Any evidence of tumor metastasis or co-existing malignant disease
Tumor emergency
Abnormal coagulation condition
Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
Concomitant tumors
Immunological co-morbidities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu Li
Phone
+86 028-85422589
Email
liqiu@scu.edu.cn
Facility Information:
Facility Name
Qiu Li
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiu Li, PhD
Phone
+86 028-85422589
Email
liqiu@scu.edu.cn
First Name & Middle Initial & Last Name & Degree
Qiu Li
Phone
+86 028-85422589
Email
liqiu@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Personalized DC Vaccine for Postoperative Cancer
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