A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Recruiting · NCT06567353 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Multi-mode tumor treatment systemRadiofrequency ablation therapeutic apparatus
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, China