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

Not Applicable

Recruiting

• Conditions: Liver Neoplasms; Metastasis; Breast Neoplasms
• Interventions: Device: Multi-mode tumor treatment system; Device: Radiofrequency ablation therapeutic apparatus

• Registration Number: NCT06567353
• Lead Sponsor: Ruijin Hospital

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 treatment of breast cancer liver metastases.

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 radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-22
• Study Start: 2024-12-09
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-mode ablation	Multi-mode tumor treatment system	Subjects in this arm will receive image-guided multi-mode ablation.
Conventional radiofrequency ablation	Radiofrequency ablation therapeutic apparatus	Subjects in this arm will receive image-guided radiofrequency ablation.

Primary Outcome Measures

Name	Time	Method
Anti-tumor immune response	max 24 months	The anti-tumor immune response refers to the effect and mechanism by which multi-mode ablation activates systemic persistent specific anti-tumor immunity, thereby inhibiting tumor metastasis and recurrence.

Secondary Outcome Measures

Name	Time	Method
6-Month Progression-Free Survival	6 months	6-month progression-free survival (6-month PFS) refers to the percentage of patients who are alive without tumor progression or metastasis six months after the start of treatment.
1-Year Overall Survival	1 year	1-year overall survival (1-year OS) refers to the percentage of patients who are still alive one year after the start of treatment.
6-Month Local Control Rate	6 months	6-month local control rate (LCR) refers to the proportion of patients in whom the primary tumor site lesions are completely suppressed after treatment among all treated patients six months after the start of treatment.
1-Year Progression-Free Survival	1 year	1-year progression-free survival (1-year PFS) refers to the percentage of patients who are alive without tumor progression or metastasis one year after the start of treatment.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China