Recruiting
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
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.
ClinicalTrials.gov IDNCT06567353
PhaseNA
Enrollment10
SponsorRuijin Hospital
Age18 Years – 75 Years
SexFEMALE
Conditions studied
Breast Neoplasms, Liver Neoplasms, Metastasis
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.
Interventions
- Device: Multi-mode tumor treatment system — 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.
- Device: Radiofrequency ablation therapeutic apparatus — 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.
Primary outcomes
- Anti-tumor immune response (max 24 months)
Eligibility information
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.
Study locations
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.