Treatment for breast cancer that has spread to the liver using a new ablation technique

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and effectiveness of a multi-mode integrated ablation system for treating breast cancer liver metastases. It is a single-center, parallel-controlled study involving 10 participants, with half receiving the experimental treatment and the other half undergoing conventional radiofrequency ablation. The study will assess the impact of the new technique on systemic anti-tumor immunity, comparing outcomes between the two groups over a defined treatment and follow-up period.

Why it matters

Who can join: the full rules

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.

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.