The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
Age of 18-80 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Multimodal Tumor Thermal Therapy System
- Radiofrequency Ablation System or Microwave Ablation System
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov