Actively Recruiting
A Single-center, Multi-cohort, Prospective Phase II Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors
Led by Fudan University · Updated on 2025-11-21
95
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for liver metastases arising from three common cancers: colorectal cancer, triple-negative breast cancer, and melanoma. Current treatments for these liver metastases have limitations, and this study explores the combination of multimodal thermophysical ablation therapy with immunotherapy drugs like pucotenlimab. This combination therapy aims to improve treatment outcomes by reshaping the tumor environment and activating the immune system against the tumors. The study involves three groups based on cancer type: colorectal cancer, triple-negative breast cancer, and melanoma. Each group receives multimodal ablation combined with various systemic drug therapies specific to their cancer type, such as cadonilimab and fruquintinib for colorectal cancer, pucotenlimab with other agents for breast cancer, and pucotenlimab with tailored treatments for melanoma. This phase II clinical trial is non-randomized and conducted at a single center, where patients receive these combination treatments to evaluate their effects on advanced solid tumors. Participants will be monitored for up to two years, with researchers assessing outcomes like objective response rate, disease control, duration of response, progression-free survival, overall survival, and safety. Throughout the study, patients will undergo regular evaluations including clinical assessments, laboratory tests, and imaging to track tumor response and treatment tolerability. The study aims to provide valuable information on the effectiveness and safety of combining multimodal ablation with systemic drug therapy for liver metastases from these cancers.
CONDITIONS
Brief Title
A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- At least three liver metastases present
- At least one measurable lesion 1 cm or larger besides ablation lesions
- Ablation lesions smaller than 5 cm in diameter
- Expected survival of at least 3 months
- ECOG performance status score of 0-1
- Adequate organ function based on recent laboratory tests
- Specific cancer cohort criteria: colorectal cancer with unresectable or surgery-intolerant liver metastases and failed standard second-line therapy; triple-negative breast cancer confirmed and failed standard second-line therapy including PD-1 antibody; melanoma with inoperable or intolerable liver lesions and failed standard first-line therapy
You will not qualify if you...
- Known allergy or suspected allergy to study drugs or similar drugs
- Participation in another clinical study with treatment within 4 weeks prior to enrollment
- History or presence of other malignant tumors except certain cured cancers
- Immunodeficiency or systemic corticosteroid/immunosuppressive therapy use
- Symptomatic or uncontrolled central nervous system metastases
- Prior organ or bone marrow transplantation
- Uncontrollable pleural, pericardial effusion, or ascites causing respiratory problems
- Recent variceal bleeding within one month
- Other antitumor treatments outside the study regimen
- Clinically significant electrolyte abnormalities
- Major organ insufficiency or failure
- Recent systemic or local liver treatments within one month
- Severe immune-related adverse events from prior immunotherapy
- Active or uncontrolled severe infections
- Other medical or laboratory conditions making participation unsafe
- Pregnancy, breastfeeding, or positive pregnancy test
- Known HIV infection or significant liver diseases including active hepatitis B or C
- Severe heart, lung, liver, or kidney dysfunction, irreversible coagulation disorders, or uncontrolled conditions like hypertension or diabetes
- Additional cohort-specific exclusions such as uncontrolled hypertension, significant proteinuria, gastrointestinal bleeding risks, cardiovascular diseases, heart failure, ventricular arrhythmias, or inability to take specific study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive multimodal ablation combined with systemic drug therapy tailored to their specific cancer type.
Visits occur regularly during treatment for therapy administration and monitoring
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
H
Hongxia Wang, MD
W
Wentao Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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