Actively Recruiting
A Phase II Clinical 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
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Three or more liver metastases present
- At least one measurable lesion of 1 cm or larger besides the ablation lesions
- Ablation lesions smaller than 5 cm in diameter
- Expected survival of 3 months or more
- ECOG performance status score of 0 or 1
- Adequate organ function shown by blood tests within 14 days before first dose: a) White blood cell count ≥3.0 x 10^9/L; absolute neutrophil count ≥1.5 x 10^9/L; platelet count ≥75 x 10^9/L; hemoglobin ≥90 g/L b) Liver function: Child-Pugh score ≤7; AST and ALT ≤5 times upper limit of normal; total bilirubin ≤1.5 times upper limit of normal c) Renal function: creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥60 mL/min d) Coagulation: INR ≤1.5 times upper limit of normal (or ≤3 times if on anticoagulants discontinued one week before ablation); APTT ≤1.5 times upper limit of normal
- For colorectal cancer cohort: a) Confirmed colorectal cancer with unresectable liver metastases or intolerance/refusal of surgery b) Patients who have failed standard second-line drug therapy
- For triple-negative breast cancer cohort: a) Confirmed triple-negative breast cancer (less than 1% ER and PR expression and HER2 negative) b) Patients who have failed standard second-line drug therapy, including PD-1 monoclonal antibody therapy
- For melanoma cohort: a) Confirmed melanoma liver metastases not suitable for surgery b) Patients who have failed standard first-line drug therapy
You will not qualify if you...
- Allergy or suspected allergy to study drugs or similar drugs
- Participation in another clinical trial with treatment within 4 weeks before enrollment
- History or presence of other malignant tumors except certain cured skin, bladder, cervical, or thyroid cancers
- Immunodeficiency or current systemic corticosteroid or immunosuppressive therapy
- Uncontrolled symptomatic central nervous system metastases
- Prior organ or bone marrow transplantation
- Uncontrollable pleural or pericardial effusion or ascites causing respiratory problems
- Esophageal or gastric variceal bleeding within the last month
- Receiving other antitumor treatments outside the study regimen
- Significant electrolyte abnormalities
- Major organ insufficiency or failure
- Recent systemic therapy or local liver treatment within 1 month
- Prior immunotherapy with severe immune-related adverse events
- Active or uncontrolled severe infections
- Any other medical or laboratory conditions deemed unsafe by the investigator
- Pregnant or breastfeeding women or positive pregnancy test
- Known HIV infection or significant liver disease including active hepatitis B or C
- Severe heart, lung, liver, or kidney dysfunction or irreversible coagulation disorders
- Other conditions affecting safety or compliance as judged by investigator
- Additional for colorectal cancer: a) Uncontrolled hypertension despite single medication or requiring multiple medications b) Significant proteinuria or gastrointestinal bleeding risks c) Significant cardiovascular disease or heart failure beyond NYHA class II d) Unable to take fruquintinib orally
- Additional for triple-negative breast cancer: a) Previous treatment with pucotenlimab
- Additional for melanoma: a) Previous treatment with pucotenlimab b) Uncontrolled hypertension despite monotherapy or needing multiple medications c) Significant proteinuria d) Significant cardiovascular disease or heart failure beyond NYHA class II
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
H
Hongxia Wang, MD
CONTACT
W
Wentao Li, MD
CONTACT
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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