Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer

Phase 1

• Conditions: Stage IV Gastric Cancer
• Interventions: Biological: Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene

• Registration Number: NCT01637805
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AAV-DC-CTL	Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	Up to 12 months	CR + PR = ORR

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China