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

NCT06567353 | Recruiting

• 1 other identifier: 0306v1.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Liver Neoplasms; Metastasis

Keywords

Multi-mode Thermophysical Immunotherapy

Outcome Measures

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.

  max 24 months

Secondary Outcomes (4)

• 6-Month Local Control Rate

  6 months

• 6-Month Progression-Free Survival

  6 months

• 1-Year Progression-Free Survival

  1 year

• 1-Year Overall Survival

  1 year

Study Arms (2)

Multi-mode ablation

EXPERIMENTAL

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

Device: Multi-mode tumor treatment system

Conventional radiofrequency ablation

ACTIVE COMPARATOR

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

Device: Radiofrequency ablation therapeutic apparatus

Interventions

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.

Also known as: MTT-P1

Multi-mode ablation

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.

Also known as: S-1500

Conventional radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Liver Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2024-05

Locations

CN (1)