Actively Recruiting
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Led by Ruijin Hospital · Updated on 2025-03-14
10
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a multi-mode integrated ablation system for treating breast cancer liver metastases in a single-center, parallel-controlled clinical study. The study aims to assess the safety, effectiveness, and impact on the body's anti-tumor immune response of this new ablation technique compared to conventional radiofrequency ablation. Participants are women aged 18 to 75 with confirmed breast cancer liver metastases who cannot or choose not to have surgery. The trial will enroll 10 women, randomly assigned to receive either the multi-mode ablation treatment or conventional radiofrequency ablation. The multi-mode treatment involves rapid freezing of tumor tissue to form an ice ball beyond the lesion, followed by thawing and radiofrequency ablation to fully treat the tumor with a safety margin. The conventional group receives radiofrequency ablation using preset power and time settings to ensure a safety margin around the tumor. Participants undergo a screening phase, treatment phase, and follow-up period lasting up to 24 months. Researchers will monitor the anti-tumor immune response and measure local control rates, progression-free survival at 6 months and 1 year, and overall survival at 1 year. Safety and treatment effects will be assessed throughout to understand the impact of the new multi-mode ablation system compared to standard care.
CONDITIONS
Brief Title
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Pathologically confirmed breast cancer liver metastases
- Unable to tolerate or refuse surgical resection
- Three or fewer liver lesions, each 4 cm or smaller in diameter
- At least one month since last local treatment
- Child-Pugh class A or B liver function
- ECOG performance status score of 2 or less with expected survival over 3 months
You will not qualify if you...
- Liver function Child-Pugh class C
- Systemic widespread metastasis with expected survival under 3 months
- History of esophageal or gastric variceal bleeding within past month
- Dysfunction or failure of vital organs
- Active infection present
- Irreparable coagulation abnormality
- Refractory massive ascites, pleural effusion, or cachexia
- Pregnancy, altered consciousness, or inability to cooperate with treatment
- Participation in other clinical studies with ongoing follow-up
- Any other factors deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with immediate procedure duration
Participants receive image-guided multi-mode ablation or conventional radiofrequency ablation to treat breast cancer liver metastases using specialized tumor treatment systems.
1 treatment visit (in-person)
Duration - Up to 12 months
Participants are monitored for treatment efficacy, safety, and immune response up to 1 year after treatment.
Periodic visits over 12 months for assessments
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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