Treatment for breast cancer that has spread to the liver using a new ablation technique
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
NA · Ruijin Hospital · NCT06567353
This study is testing a new treatment method for breast cancer that has spread to the liver to see if it works better than the standard approach.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06567353 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 with pathologically confirmed breast cancer liver metastases who are unable to tolerate or refuse surgical resection.
Not a fit: Patients with severe liver dysfunction, widespread metastasis, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with breast cancer liver metastases who cannot undergo surgery.
How similar studies have performed: While similar approaches have been explored, this specific multi-mode thermophysical immunotherapy technique is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasms, Liver Neoplasms, Metastasis, Multi-mode Thermophysical Immunotherapy