- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853903
Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors
September 10, 2019 updated by: Fuda Cancer Hospital, Guangzhou
The aim of this study is the efficacy of autogenic and allogenic natural killer (NK) immunotherapy on recurrent solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
By enrolling patients with multiple kinds of solid tumor adapted to enrolled criteria, this study will document for the first time the short/long term efficacy of auto/allogenic NK cells.The outcome will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
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
-
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Guangdong
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Guangzhou, Guangdong, China, 510665
- Fuda cancer institute of Fuda cancer hospital
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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
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- Body tumor 1-6, the maximum tumor length < 5 cm
- KPS ≥ 70, lifespan > 6 months
- Platelet count ≥ 80×109/L,white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion Criteria:
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
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 |
---|---|
EXPERIMENTAL: Allogenic NK immunotherapy
In this group, the patients will receive more than 4 times of allogenic NK immunotherapies in 3 months.
The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
|
Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.
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ACTIVE_COMPARATOR: Autogenic NK immunotherapy
In this group, the patients will receive more than 4 times of autogenic NK immunotherapies in 3 months.
The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
|
Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree of tumors
Time Frame: 3 months
|
It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progress free survival(PFS)
Time Frame: 1 year
|
1 year
|
Overall survival(OS)
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ACTUAL)
July 1, 2016
Primary Completion (ACTUAL)
July 1, 2017
Study Completion (ACTUAL)
July 1, 2019
Study Registration Dates
First Submitted
July 28, 2016
First Submitted That Met QC Criteria
July 29, 2016
First Posted (ESTIMATE)
August 3, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Auto-allo NK
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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