A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
- Conditions
- Breast NeoplasmsLiver NeoplasmsMetastasis
- Registration Number
- NCT06567353
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria:<br><br> 1. Age 18-75 years, female gender;<br><br> 2. Pathologically confirmed breast cancer liver metastases, in patients who are unable<br> to tolerate or refuse surgical resection;<br><br> 3. The number of lesions = 3, with any single lesion diameter = 4cm;<br><br> 4. At least an interval of 1 month since the last local treatment;<br><br> 5. Child-Pugh class A or B;<br><br> 6. ECOG PS score =2, with an expected survival of >3 months.<br><br>Exclusion Criteria:<br><br> 1. Liver function Child-Pugh class C;<br><br> 2. Systemic widespread metastasis, with an expected survival of < 3 months;<br><br> 3. History of esophageal (gastric fundus) variceal bleeding within the past month;<br><br> 4. Dysfunction or failure of vital organs;<br><br> 5. Presence of an active infection;<br><br> 6. Irreparable coagulation abnormality;<br><br> 7. Refractory massive ascites, pleural effusion or cachexia;<br><br> 8. Pregnancy, altered consciousness or patients unable to cooperate with treatment;<br><br> 9. Previously participated in other clinical studies and still within the follow-up<br> period;<br><br> 10. Any other factors deemed inappropriate for inclusion or that may affect the<br> patient's participation in the study, as determined by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-tumor immune response
- Secondary Outcome Measures
Name Time Method 6-Month Local Control Rate;6-Month Progression-Free Survival;1-Year Progression-Free Survival;1-Year Overall Survival