Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuzhou Medical University
• Treatments: Trastuzumab

Criteria

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.