Overview

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.