Breast Cancer RecurrentPhase 1/2NCT02844335
Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer
A Phase 1/2 study testing Cryosurgery and NK immunotherapy in people with Breast Cancer Recurrent, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Breast Cancer Recurrent
- What is being tested?
- Cryosurgery and NK immunotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 1 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute in Fuda cancer hospital
Guangzhou, Guangdong, 510665
About this study
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced breast cancer.
Read the 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).
- Conditions
- Breast Cancer Recurrent
- Being tested
- Cryosurgery, NK immunotherapy
- Keywords
- Breast Cancer, Cryosurgery, NK Immunotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryosurgeryDevice
Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
NK immunotherapyBiological
Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
| Study group | Role | What they receive |
|---|---|---|
| Cryosurgery and NK immunotherapy | Experimental | 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). Receives: Device: Cryosurgery; Biological: NK immunotherapy |
| Cryosurgery | Active comparator | 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). Receives: Device: Cryosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief degree
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Measured: 3 months
Secondary outcomes (2)
Progress free survival（PFS）
Measured: 1 year
Overall survival（OS）
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Responsible party
- Sponsor
- Investigators
- Guifeng Liu, PhD, Principal investigator, Fuda Cancer Hospital, Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844335
- Sponsor's protocol ID
- NK-breast
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02844335
- Acronym / sponsor ID
- NK-breast
- Conditions
- Breast Cancer Recurrent
- Keywords
- Breast Cancer, Cryosurgery, NK Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced breast cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryosurgery and NK immunotherapy | Experimental | Device: Cryosurgery, Biological: NK immunotherapyIn 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). |
| Cryosurgery | Active comparator | Device: CryosurgeryIn 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryosurgeryArgon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance) | Device | Cryosurgery, Cryosurgery and NK immunotherapy |
| NK immunotherapyNatural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.) | Biological | Cryosurgery and NK immunotherapy |
Primary outcome
Relief degree
Time frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
2 secondary outcomes
Progress free survival（PFS）
Time frame: 1 year
Overall survival（OS）
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guifeng Liu, PhD principal investigator
Fuda Cancer Hospital, Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cryosurgery and NK immunotherapy in people with Breast Cancer Recurrent, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief degree (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.