Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
AAV-DC-CTL
Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 8, 2016
July 1, 2012
4.4 years
July 3, 2012
March 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
CR + PR = ORR
Up to 12 months
Study Arms (1)
AAV-DC-CTL
EXPERIMENTALInterventions
AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle
Eligibility Criteria
You may qualify if:
- Sex: male or female
- Age: from 18 to 80 years
- Histology: gastric cancer
- Clinical stage: stage IV
- Karnofsky performance status: more than 50%
- Expected survival: more than 2 months
- Sex: male or female
- Laboratory tests results 7 days before the start of treatment:
- White blood cells: more than 3.0 × 109/L
- Platelets: more than 100 × 109/L
- Neutrophils: more than 1.5 × 109/L
- Hemoglobin: more than 80g/L
- Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
- Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
- Serum bilirubin: less than 1.25 × ULN
- +4 more criteria
You may not qualify if:
- History of neoplasms: other neoplasms
- Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
- Metastasis: clinical symptoms of brain metastasis
- Other clinical trial: the subject received other clinical trial before this study
- Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
- Woman: pregnant or lactating women
- Compliance: poor compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 11, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
March 8, 2016
Record last verified: 2012-07