Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
NCT ID: NCT02862587
Last Updated: 2016-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
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To evaluate the safety and effectiveness of cell therapy using precision cells to treat Advanced Lung 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 Lung Cancer.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Precision Cells
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.
Chemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
precision cells
precision cells 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. PNAT/PMAT cell suspension (1-6×109 PNAT + 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.
Chemotherapy
Once a week with a total of six times before 60 days prior to the start of drawing blood.
Chemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Interventions
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Chemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
precision cells
precision cells 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. PNAT/PMAT cell suspension (1-6×109 PNAT + 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.
Eligibility Criteria
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Inclusion Criteria
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (lung 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
* 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.
18 Years
25 Years
ALL
No
Sponsors
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Shanghai International Medical Center
INDUSTRY
Responsible Party
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Locations
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Shanghai International Medical Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SIMC-20160104
Identifier Type: -
Identifier Source: org_study_id
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