Clinical trial · Interventional
Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer
Combination Trastuzumab With Expanded NK Cells for Treating HER2-positive Gastric Cancer
NCT02805829CI-TRIAL-00022667unknownPhase 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)
This trial is to evaluate the safety and effectiveness of activated and expanded in vitro autologous NK cells following trastuzumab treatment for patients Human Epidermal Receptor-2 overexpressing advanced 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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab + NK cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab + NK cells
- description
- On Cycle 1,day -2, patients will receive IV loading dose 8mg/Kg trastuzumab, followed by collection blood on day 0. After NK expansion and verification that the resulting NK cells meet release criteria, NK cells were washed and resuspended in isotonic sodium chloride for intravenous transfusion on day 14. NK cellular therapy conduct 2 cycles per year. The maintenance dose of trastuzumab monotherapy is 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.
- interventionNames
- Drug: Trastuzumab + NK cells
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Number of Participants with tumor recurrence metastasis as a Measure of effectiveness
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age equal to 18 years or older; * Patients with histologically confirmed HER2 positive advanced gastric cancer through immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); * Normal marrow hematopoiesis function: Hemoglobin≥90g/L, White Blood Cell count≥4000/μL, absolute Neutrophil Cell count (ANC)≥1500/μL, Platelet≥100000/μL; * Normal important organ function: Total bilirubin≤1.5-fold institutional upper limit of normal (ULN), Aspartate aminotransferase and Alanine aminotransferase≤2.5-fold ULN, Creatinine clearance≥80mL/min; * Life expectancy≥6 months; * No other serious heart, lung, kidney dysfunction; * Quality of life (Karnofsky performance score)≥60; * Patient must be able to understand and be willing to sign a written informed consent document. Exclusion Criteria: * Prior allergic reaction or hypersensitivity to cytokines (eg.Interleukin-2); * Patients with systemic or local infection requiring anti-infections treatment; * Patients currently treated with systemic immunosuppressive agents, including steroids; * Patients with active autoimmune disease or history of transplantation requiring steroid treatment; * Tested positive for HIV; * Pregnant or lactating women; * Patients with coagulation disorders; * Patients with important organ dysfunction, including cardiac, lung, liver; * Patients experiencing a cardiac events (acute coronary syndrome, myocardial infarction or ischemia) within the 3 months; * Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.