NCT06889610

A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.

A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.

Conditions

• Triple Negative Breast Cancer Metastatic
• Melanoma Metastatic
• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer	Multimodal ablation combined with cadonilimab and fruquintinib
COMBINATION_PRODUCT	MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer	Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1
COMBINATION_PRODUCT	MTT(Multimodal Tumor Thermal Therapy System)- Melanoma	Multimodal ablation combined with pucotenlimab, with other specific agents determined based on the first-line treatment regimen and the melanoma subtype.

Timeline

• Start date: 2025-11-04
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-03-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: China