Breast CancerPhase 1/2NCT03183206
Safety and Efficiency of γδ T Cell Against Breast Cancer
A Phase 1/2 study testing Cryosurgery , IRE surgery ,surgery, γδ T cells and γδ T cells/ Surgery in people with Breast Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated. Read more about this study
- Who is it for?
- Ages 15 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cryosurgery , IRE surgery ,surgery, γδ T cells and γδ T cells/ Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 15 Jun 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 15 to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 18-75 Karnofsky performance status >50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 months Ability to understand the study protocol and a willingness to sign a written informed consent document
Who cannot join
- Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease Insulin dependent diabetes Thyroid disease
Trial locations and contacts
1 site in 1 country.
China1 site
Biotherapy center in Fuda cancer hospital
Guangzhou, Guangdong, 510665
About this study
Official title: γδ T Cell Immunotherapy for Treatment of Breast Cancer
In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.
Read the detailed description
Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.
Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.
- Conditions
- Breast Cancer
- Being tested
- Cryosurgery , IRE surgery ,surgery, γδ T cells, γδ T cells/ Surgery
- Keywords
- Immunotherapy, γδ T Cell, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryosurgery , IRE surgery ,surgeryProcedure or surgery
surgery will be used in local tumor
γδ T cellsBiological
γδ T cells will be used against
γδ T cells/ SurgeryOther
Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor Receives: Procedure: Cryosurgery , IRE surgery ,surgery |
| Group B | Experimental | In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell) Receives: Biological: γδ T cells |
| Group C | Experimental | In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery Receives: Other: γδ T cells/ Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief degree of tumors
Measured: 3 months
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 posted12 Jun 2017
- Study start15 Jun 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan University Guangzhou
- Responsible party
- Sponsor
- Investigators
- Jibing Chen, PhD, Principal investigator, Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183206
- Sponsor's protocol ID
- Gd T cell and Breast Ca
- Status last verified
- Jul 2020
- First submitted
- 8 Jun 2017
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- γδ T Cell Immunotherapy for Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT03183206
- Acronym / sponsor ID
- Gd T cell and Breast Ca
- Conditions
- Breast Cancer
- Keywords
- Immunotherapy, γδ T Cell, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Jinan University Guangzhou
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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.
In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.
Detailed description
Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.
Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Cryosurgery , IRE surgery ,surgeryIn this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor |
| Group B | Experimental | Biological: γδ T cellsIn this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell) |
| Group C | Experimental | Other: γδ T cells/ SurgeryIn this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 18-75 Karnofsky performance status >50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 months Ability to understand the study protocol and a willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease Insulin dependent diabetes Thyroid disease
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 |
|---|---|---|
| Cryosurgery , IRE surgery ,surgerysurgery will be used in local tumor | Procedure or surgery | Group A |
| γδ T cellsγδ T cells will be used against | Biological | Group B |
| γδ T cells/ SurgeryCombination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer | Other | Group C |
Primary outcome
Relief degree of tumors
Time frame: 3 months
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 13 Jul 2020.
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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.
Jibing Chen, PhD principal investigator
Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
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 , IRE surgery ,surgery, γδ T cells and γδ T cells/ Surgery in people with Breast Cancer, 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 1 inclusion and 1 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 13 Jul 2020. 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 of tumors (time frame: 3 months). The study lists 3 primary outcomes in all. 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 13 Jul 2020.