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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Metastasis; Liver Neoplasms; Breast Neoplasms

Treatments: Device: Multi-mode tumor treatment system; Device: Radiofrequency ablation therapeutic apparatus

Study type: Interventional

Funder types: Other

Identifiers

NCT06567353

0306v1.1

Details and patient eligibility

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Multi-mode ablation

Experimental group

Description:

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

Treatment:

Device: Multi-mode tumor treatment system

Conventional radiofrequency ablation

Active Comparator group

Description:

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

Treatment:

Device: Radiofrequency ablation therapeutic apparatus