The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malig… (NCT07159048) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors
120 participantsStarted 2025-09-10
Plain-language summary
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age of 18-75 years.
✓. Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.
✓. Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5.
✓. Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.
✓. Child-Pugh score ≤7 (Class A or B).
✓. Performance status 0-1 (Eastern Cooperative Oncology Group classification).
✓. Life expectancy of at least 3 months.
✓. Patients who have previously undergone surgery, chemotherapy, targeted therapy, ablation, vascular interventional therapy (TACE, D-TACE, HAIC), or immunotherapy, with an interval of ≥3 weeks since the last treatment.
Exclusion criteria
✕. Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.
✕. Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume.
✕. Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.
✕. Active bacterial infection or fungal infection.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: At 12 months after the ablation procedure on Day 0