RecruitingNot ApplicableNCT06567353

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

Sponsor

Ruijin Hospital

Enrollment

10 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Metastasis Liver Neoplasms

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: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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.

Exclusion Criteria10

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;
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.

Interventions

DEVICEMulti-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.

DEVICERadiofrequency 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.