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Clinical Trials in China / NCT06567353
Recruiting Not applicable

A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases

NCT06567353 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Not applicable
Started
2024-12-09
Last updated
2025-03-14

Condition(s) studied

Breast NeoplasmsLiver NeoplasmsMetastasis

Investigational drug(s) / intervention(s)

Multi-mode tumor treatment systemRadiofrequency ablation therapeutic apparatus

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Anti-tumor immune response — 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.

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06567353 on ClinicalTrials.gov ↗ ← All trials in China