- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844335
Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced breast cancer.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510665
- Cancer Institute in Fuda cancer hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryosurgery and NK immunotherapy
In this group, the patients will receive comprehensive cryosurgery first to destroy all big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months).
The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).
|
Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
|
Active Comparator: Cryosurgery
In this group, the patients will receive comprehensive cryosurgery to destroy all big tumors.
The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).
|
Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree
Time Frame: 3 months
|
It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
|
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NK-breast
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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