Overview

Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Status:
Unknown status
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
All
Summary
Objectives: To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Gastric Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai International Medical Center
Criteria
Inclusion Criteria:

- Age 18~65 years old, male or female;

- Life expectancy≥6 months;

- ECOG score: 0-3;

- Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical
physicians;

- Enough venous channel, no other contraindications to the separation and collection of
white blood cells;

- Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L,
hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less
than five times of the normal level; serum creatinine less than 1.5 times of the
normal level;

- Signed informed consent;

- Women of child-bearing age must have evidence of negative pregnancy test and be
willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

- Expected Overall survival < 6 months;

- Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease
(uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (>
Class II, NYHA), or myocardial infarction within 6 months;

- Other serious diseases: nervous, mental disorders, immune regulatory diseases,
metabolic diseases, infectious diseases, etc;

- Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed
within a month;

- Unable or unwilling to provide informed consent, or fail to comply with the test
requirements.