Efficacy Study of TKcell in Advanced Gastric Cancer

Binex

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Advanced Gastric Cancer

Treatments: Biological: TKCell

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854854

BX-TK-001

Details and patient eligibility

About

The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer

Enrollment: 94 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Control

No Intervention group

Description:

* Oxaliplatin infusion (100mg/m2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m2) on days 1, 2, 15 and 16 * LV infusions (200 mg/m2) on days 1, 2, 15 and 16

Active

Active Comparator group

Description:

Infusion of TKCell(autologous activated lymphocyte) over 2x10\^9 cells, IV route, 7 times and chemotherapy schedule

Treatment:

Biological: TKCell