Status:
UNKNOWN
Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer
Lead Sponsor:
Xuzhou Medical University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 adv...
Detailed Description
Tumor antigen-specific monoclonal antibodies, block oncogenic signaling and induce Fcγ receptor (FcγR)-mediated cytotoxicity, are considered to be one of the most successful strategies in cancer thera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02805829
Start Date
January 1 2017
End Date
January 1 2020
Last Update
June 22 2016
Active Locations (1)
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1
Xuzhou medical university
Xuzhou, Jiangsu, China, 221002