- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02862561
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201318
- Recruiting
- Shanghai International Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Precision Cell Immunotherapy
Precision Cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. Precision Cells:once per 3 weeks with a total of three periods. |
Cisplatin:60mg/m2,5-FU:500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
|
ACTIVE_COMPARATOR: Chemotherapy
Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. |
Cisplatin:60mg/m2,5-FU:500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
Progress-free survival
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIMC-20160105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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