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Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Gastric Cancer


Phase 1/Phase 2
19 Years
N/A
Open (Enrolling by invite only)
Both
Advanced Gastric Cancer

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Trial Information

Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Gastric Cancer


Inclusion Criteria:



- Written informed consent.

- Diagnosis of histologically confirmed adenocarcinoma of the gastric

- ECOG performance status of 0 - 2

- At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in
physical examination

- Adequate liver, renal, bone marrow functions as evidence by the following; Absolute
neutrophil count > 1.5 x 109/L; platelets > 7.5 x 109/L; Bilirubin less than 2 mg/dL
ASAT and/or ALAT < 5 UNL; serum creatinine ≤ 2 ULN

- Minimum life expectancy of 12 weeks

- Effective contraception for both male and female subjects if the risk of conception
exists

Exclusion Criteria:

- Brain metastasis and/or leptomeningeal disease (known or suspected)

- Previous chemotherapy for gastric cancer except adjuvant treatment with progression
of disease documented > 6 months after end of adjuvant treatment.

- Previous oxaliplatin-based chemotherapy

- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to
randomization and chemotherapy

- HIV antibody (+), Chronic hepatitis

- Uncontrolled infection

- Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal
therapy not indicated in the study protocol except for contraception

- Clinically relevant coronary artery disease, history of myocardial infarction, high
risk of uncontrolled arrhythmia

- Known hypersensitivity reaction to any of the components of the treatment.

- Pregnancy (absence to be confirmed by ß-hCG test) or lactation period

- Participation in another clinical study within the 30 days before randomization

- Significant disease which, in the investigator's opinion, would exclude the subject
from the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine response rate

Outcome Time Frame:

within study period

Safety Issue:

Yes

Principal Investigator

Seok-Goo Cho, M.D, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Catholic Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

BX-TK-001

NCT ID:

NCT00854854

Start Date:

January 2009

Completion Date:

July 2010

Related Keywords:

  • Advanced Gastric Cancer
  • NKCell
  • FOLFOX-4
  • gastric cancer
  • Stomach Neoplasms

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