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Trial Title:
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
NCT ID:
NCT06567353
Condition:
Breast Neoplasms
Liver Neoplasms
Metastasis
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Liver Neoplasms
Conditions: Keywords:
Multi-mode Thermophysical Immunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multi-mode tumor treatment system
Description:
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.
Arm group label:
Multi-mode ablation
Other name:
MTT-P1
Intervention type:
Device
Intervention name:
Radiofrequency ablation therapeutic apparatus
Description:
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.
Arm group label:
Conventional radiofrequency ablation
Other name:
S-1500
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years, female gender;
2. Pathologically confirmed breast cancer liver metastases, in patients who are unable
to tolerate or refuse surgical resection;
3. The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
4. At least an interval of 1 month since the last local treatment;
5. Child-Pugh class A or B;
6. ECOG PS score ≤2, with an expected survival of >3 months.
Exclusion Criteria:
1. Liver function Child-Pugh class C;
2. Systemic widespread metastasis, with an expected survival of < 3 months;
3. History of esophageal (gastric fundus) variceal bleeding within the past month;
4. Dysfunction or failure of vital organs;
5. Presence of an active infection;
6. Irreparable coagulation abnormality;
7. Refractory massive ascites, pleural effusion or cachexia;
8. Pregnancy, altered consciousness or patients unable to cooperate with treatment;
9. Previously participated in other clinical studies and still within the follow-up
period;
10. Any other factors deemed inappropriate for inclusion or that may affect the
patient's participation in the study, as determined by the investigator.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567353
