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

Launched by RUIJIN HOSPITAL · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat breast cancer that has spread to the liver. Researchers want to see if a special treatment called a multi-mode integrated ablation system is safe and effective for patients who cannot have surgery. The focus is also on how this treatment affects the body's immune response against the cancer.

To participate in this study, women aged 18 to 75 who have been diagnosed with breast cancer that has spread to the liver may be eligible, especially if they have up to three tumors that are not larger than 4 centimeters. Participants must have a good level of liver function and be expected to live for more than three months. If you join the trial, you will receive this new treatment and be closely monitored to see how well it works and if there are any side effects. If you have other serious health issues, such as severe liver problems or widespread cancer, you may not be able to participate. This study is currently recruiting participants, so it’s a chance to explore a potentially new treatment option.

Gender

FEMALE

Eligibility 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.