Health TrialsbyHealthPanel

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

ConditionsBreast NeoplasmsLiver NeoplasmsMetastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-mode tumor treatment system

    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.

  • Radiofrequency ablation therapeutic apparatus

    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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Multi-mode ablationExperimental treatment 1 intervention
Group B: Conventional radiofrequency ablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Anti-tumor immune response

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.

Time frame
max 24 months

Secondary outcomes

1

6-Month Local Control Rate

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.

Time frame
6 months
2

6-Month Progression-Free Survival

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.

Time frame
6 months
3

1-Year Progression-Free Survival

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.

Time frame
1 year
4

1-Year Overall Survival

1-year overall survival (1-year OS) refers to the percentage of patients who are still alive one year after the start of treatment.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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