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

NCT ID: NCT06567353

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-09
• Study Completion Date: 2027-12-31

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.

Conditions

Breast Neoplasms; Liver Neoplasms; Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-mode ablation

Subjects in this arm will receive image-guided multi-mode ablation.

Group Type: EXPERIMENTAL

Multi-mode tumor treatment system

Intervention Type: DEVICE

All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone including a safety margin of 5-10mm around the tumor.

Conventional radiofrequency ablation

Subjects in this arm will receive image-guided radiofrequency ablation.

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation therapeutic apparatus

Intervention Type: DEVICE

All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm.

Interventions

Multi-mode tumor treatment system

All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone including a safety margin of 5-10mm around the tumor.

Intervention Type: DEVICE

Radiofrequency ablation therapeutic apparatus

All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm.

Intervention Type: DEVICE

Other Intervention Names

MTT-P1; S-1500

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Chief Physician of Interventional Radiology Department

Role: primary

dxy10456@rjh.com.cn

021-64370045

Other Identifiers

0306v1.1

Identifier Type: -

Identifier Source: org_study_id