Status:
RECRUITING
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Lead Sponsor:
Ruijin Hospital
Conditions:
Breast Neoplasms
Liver Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 trea...
Detailed Description
This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequenc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06567353
Start Date
December 9 2024
End Date
December 1 2027
Last Update
March 14 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China