Clinical trial · Interventional
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
NCT06567353CI-TRIAL-00087254recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-mode tumor treatment system | Device | — | UNRESOLVED |
| Radiofrequency ablation therapeutic apparatus | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multi-mode ablation
- description
- Subjects in this arm will receive image-guided multi-mode ablation.
- interventionNames
- Device: Multi-mode tumor treatment system
- type
- ACTIVE_COMPARATOR
- label
- Conventional radiofrequency ablation
- description
- Subjects in this arm will receive image-guided radiofrequency ablation.
- interventionNames
- Device: Radiofrequency ablation therapeutic apparatus
Primary outcomes (1)
- measure
- Anti-tumor immune response
- timeFrame
- max 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.