RecruitingPhase 2NCT06889610

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.

Sponsor

Fudan University

Enrollment

95 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Triple Negative Breast Cancer Metastatic Melanoma Metastatic Colorectal Cancer Metastatic

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using tumor ablation (destroying tumors with heat or cold probes) alongside standard systemic drug therapies helps people with advanced solid cancers that have spread to the liver. The ablation targets specific liver tumors while drugs treat the rest of the disease. **You may be eligible if...** - You are between 18 and 80 years old - You have 3 or more liver metastases, with at least one additional measurable tumor elsewhere - The tumors to be ablated are each smaller than 5 cm - Your cancer is expected to allow at least 3 months of survival - Your performance status is good (ECOG 0–1) - Your blood counts and organ function are within acceptable limits **You may NOT be eligible if...** - You have severe heart, liver, or kidney disease - You are pregnant or breastfeeding - Your tumors are not technically suitable for ablation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer

Multimodal ablation combined with cadonilimab and fruquintinib

COMBINATION_PRODUCTMTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer

Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1

COMBINATION_PRODUCTMTT(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.

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06889610

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