Breast NeoplasmsNCT06567353
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
A study testing Multi-mode tumor treatment system and Radiofrequency ablation therapeutic apparatus in people with Breast Neoplasms and Liver Neoplasms, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Liver Neoplasms, Metastasis
- What is being tested?
- Multi-mode tumor treatment system and Radiofrequency ablation therapeutic apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, female gender;
- Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection;
- The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
- At least an interval of 1 month since the last local treatment;
- Child-Pugh class A or B;
- ECOG PS score ≤2, with an expected survival of >3 months.
Who cannot join
- Liver function Child-Pugh class C;
- Systemic widespread metastasis, with an expected survival of < 3 months;
- History of esophageal (gastric fundus) variceal bleeding within the past month;
- Dysfunction or failure of vital organs;
- Presence of an active infection;
- Irreparable coagulation abnormality;
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- Refractory massive ascites, pleural effusion or cachexia;
- Pregnancy, altered consciousness or patients unable to cooperate with treatment;
- Previously participated in other clinical studies and still within the follow-up period;
- Any other factors deemed inappropriate for inclusion or that may affect the patient's participation in the study, as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Chief Physician of Interventional Radiology Department, 021-64370045, dxy10456@rjh.com.cn
About this study
This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.
Read the detailed description
This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.
- Conditions
- Breast Neoplasms, Liver Neoplasms, Metastasis
- Being tested
- Multi-mode tumor treatment system, Radiofrequency ablation therapeutic apparatus
- Keywords
- Multi-mode Thermophysical Immunotherapy
- Medical subject headings
- Breast Neoplasms, Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-mode tumor treatment systemDevice
Also called MTT-P1
All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone including a safety margin of 5-10mm around the tumor.
Radiofrequency ablation therapeutic apparatusDevice
Also called S-1500
All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm.
| Study group | Role | What they receive |
|---|---|---|
| Multi-mode ablation | Experimental | Subjects in this arm will receive image-guided multi-mode ablation. Receives: Device: Multi-mode tumor treatment system |
| Conventional radiofrequency ablation | Active comparator | Subjects in this arm will receive image-guided radiofrequency ablation. Receives: Device: Radiofrequency ablation therapeutic apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tumor immune response
The anti-tumor immune response refers to the effect and mechanism by which multi-mode ablation activates systemic persistent specific anti-tumor immunity, thereby inhibiting tumor metastasis and recurrence.
Measured: max 24 months
Secondary outcomes (4)
6-Month Local Control Rate
6-month local control rate (LCR) refers to the proportion of patients in whom the primary tumor site lesions are completely suppressed after treatment among all treated patients six months after the start of treatment.
Measured: 6 months
6-Month Progression-Free Survival
6-month progression-free survival (6-month PFS) refers to the percentage of patients who are alive without tumor progression or metastasis six months after the start of treatment.
Measured: 6 months
1-Year Progression-Free Survival
1-year progression-free survival (1-year PFS) refers to the percentage of patients who are alive without tumor progression or metastasis one year after the start of treatment.
Measured: 1 year
1-Year Overall Survival
1-year overall survival (1-year OS) refers to the percentage of patients who are still alive one year after the start of treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start9 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567353
- Sponsor's protocol ID
- 0306v1.1
- Status last verified
- May 2024
- First submitted
- 20 Aug 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT06567353
- Acronym / sponsor ID
- 0306v1.1
- Conditions
- Breast Neoplasms, Liver Neoplasms, Metastasis
- Keywords
- Multi-mode Thermophysical Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 2024 (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.
This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.
Detailed description
This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-mode ablation | Experimental | Device: Multi-mode tumor treatment systemSubjects in this arm will receive image-guided multi-mode ablation. |
| Conventional radiofrequency ablation | Active comparator | Device: Radiofrequency ablation therapeutic apparatusSubjects in this arm will receive image-guided radiofrequency ablation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years, female gender;
- Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection;
- The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
- At least an interval of 1 month since the last local treatment;
- Child-Pugh class A or B;
Key exclusion criteria (10 listed)
- Liver function Child-Pugh class C;
- Systemic widespread metastasis, with an expected survival of < 3 months;
- History of esophageal (gastric fundus) variceal bleeding within the past month;
- Dysfunction or failure of vital organs;
- Presence of an active infection;
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 |
|---|---|---|
| Multi-mode tumor treatment systemAlso: MTT-P1All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone including a safety margin of 5-10mm around the tumor. | Device | Multi-mode ablation |
| Radiofrequency ablation therapeutic apparatusAlso: S-1500All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm. | Device | Conventional radiofrequency ablation |
Primary outcome
Anti-tumor immune response
Time frame: max 24 months
The anti-tumor immune response refers to the effect and mechanism by which multi-mode ablation activates systemic persistent specific anti-tumor immunity, thereby inhibiting tumor metastasis and recurrence.
4 secondary outcomes
6-Month Local Control Rate
Time frame: 6 months
6-Month Progression-Free Survival
Time frame: 6 months
1-Year Progression-Free Survival
Time frame: 1 year
1-Year Overall Survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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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.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-mode tumor treatment system and Radiofrequency ablation therapeutic apparatus in people with Breast Neoplasms and Liver Neoplasms, run by Ruijin Hospital 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tumor immune response (time frame: max 24 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 14 Mar 2025.