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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: At 12 months after the ablation procedure on Day 0
. 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.
. Previous or coexisting malignancies.
. History of solid organ transplant or hepatic encephalopathy.
. Current enrollment in another clinical trial or prior exposure to experimental therapies.
. Pregnant or breastfeeding, or preparing to pregnant.