Clinical trial · Interventional
Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
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
NCT01637805CI-TRIAL-00021250AAV-DC-CTLunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AAV-DC-CTL
- interventionNames
- Biological: Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Up to 12 months
- description
- CR + PR = ORR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Serum creatinine: less than 1.25 × ULN * Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment * Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study * Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.