- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873416
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
October 6, 2016 updated by: Ningbo Cancer Hospital
Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy 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.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
A total of 40 patients may be enrolled over a period of 1-2 years.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Ningbo, Zhejiang, China
- Recruiting
- Ningbo No.5 Hospital (Ningbo Cancer Hospital)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18~65 years old, male or female;
- 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 x10*/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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
ACTIVE_COMPARATOR: Chemotherapy
Once a week with a total of six times before 60 days prior to the start of drawing blood.
|
Cisplatin:60mg/m2,Gemcitabine:1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
|
EXPERIMENTAL: Precision cells combined with Chemotherapy treatment:
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,Gemcitabine:1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
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. Precision 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.
|
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 |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 2 years
|
Questionnaire will be used.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (ANTICIPATED)
March 1, 2018
Study Completion (ANTICIPATED)
August 1, 2018
Study Registration Dates
First Submitted
August 15, 2016
First Submitted That Met QC Criteria
August 18, 2016
First Posted (ESTIMATE)
August 19, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
October 7, 2016
Last Update Submitted That Met QC Criteria
October 6, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBWYKY2016-06-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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