Know Cancer

or
forgot password

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


Phase 1
18 Years
80 Years
Open (Enrolling)
Both
Stage IV Gastric Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Objective response rate

Outcome Description:

CR + PR = ORR

Outcome Time Frame:

Up to 12 months

Safety Issue:

Yes

Authority:

China: Institutional Review Board of Tianjin Cancer Hospital

Study ID:

CIH-ZRP-201205001

NCT ID:

NCT01637805

Start Date:

May 2012

Completion Date:

December 2013

Related Keywords:

  • Stage IV Gastric Cancer
  • Stomach Neoplasms

Name

Location