Clinical trial · Interventional
Efficacy Study of TKcell in Advanced Gastric Cancer
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
NCT00854854CI-TRIAL-00002316unknownPhase 1 / Phase 2ClinicalTrials.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 determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer
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 |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKCell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- 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
- type
- ACTIVE_COMPARATOR
- label
- Active
- description
- Infusion of TKCell(autologous activated lymphocyte) over 2x10\^9 cells, IV route, 7 times and chemotherapy schedule
- interventionNames
- Biological: TKCell
Primary outcomes (1)
- measure
- Determine response rate
- timeFrame
- within study period
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.