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Recruiting NCT06567353

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

No phase Interventional Breast Neoplasms Liver Neoplasms Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-mode tumor treatment system, Radiofrequency ablation therapeutic apparatus.
Who it may be relevant to
Registry conditions: Breast Neoplasms, Liver Neoplasms, Metastasis. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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 includ
  • 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.

Primary outcome measures

  • Anti-tumor immune response [Time frame: max 24 months]
Secondary outcome measures (4)
  • 6-Month Local Control Rate [Time frame: 6 months]
  • 6-Month Progression-Free Survival [Time frame: 6 months]
  • 1-Year Progression-Free Survival [Time frame: 1 year]
  • 1-Year Overall Survival [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06567353 · 0306v1.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗