NCT07466927

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases: A Prospective, Open-label, Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, phase II platform trial. The purpose of this study is to test the safety and effectiveness of multi-mode thermal therapy combined with immunotherapy in patients with HER2-negative breast cancer with liver metastases who had previously received systemic therapy

Detailed description

This is a prospective, open-label, phase II trial. The purpose of this study is to test the safety and effectiveness of multi-mode thermal therapy combined with immunotherapy in patients with advanced breast cancer who had previously received systemic therapy. The primary endpoint is progression free survival. Previous studies have shown that multi-mode thermal therapy can elicit systemic anti-tumor immune responses and sensitize immunity. To further validate these findings, we have designed this study to enroll HER2-negative patients who have progressed after conventional treatments (including chemotherapy, immunotherapy, ADC, etc.), with the aim of further investigating the clinical feasibility of multi-mode thermal therapy combined with immunotherapy and ADC therapy in patients with liver metastases in HER2-negative breast cancer.

Conditions

• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811	A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
DRUG	SKB264	A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
DRUG	Pembrolizumab	PD-1 antibody, via intravenous (into the vein) infusion per protocol.
DRUG	SHR-1316	PD-L1 antibody, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-01-15
• Completion: 2029-01-15
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: China