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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Multimodal Tumor Thermal Therapy System
DeviceAll subjects were treated with a multi-modal thermal therapy system (Shanghai MAaGI Medical Technology Co., Ltd.) following a temperature-controlled tumor ablation protocol. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status.
Radiofrequency Ablation System or Microwave Ablation System
DeviceAll subjects were treated with a radiofrequency ablation system or microwave ablation System. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Multimodal Tumor Thermal TherapyExperimental treatment 1 intervention
Group B: Single Thermal AblationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
PFS was defined as the time from the first ablation until local tumor progression, any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first).
Time frame
At 12 months after the ablation procedure on Day 02
Assessment of immune activating response
The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors.
Time frame
In 6 monthsSecondary outcomes
1
Objective Response Rate（ORR）
Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Time frame
At 6 months after the ablation procedure on Day 02
Local Control Rate（LCR）
LCR is defined as the proportion of patients demonstrating absence of disease progression at the ablated target site according to mRECIST criteria, as evaluated by diagnostic imaging, without evidence of progressive disease (PD) within the prescribed follow-up period.
Time frame
At 6 months after the ablation procedure on Day 03
Overall Survival (OS)
OS refers to the time from the date of enrollment to the date of death due to any cause.
Time frame
At 36 months after the ablation procedure on Day 04
Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation
Percentage of participants with AEs within 3 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device.
Time frame
From time of first ablation (Day 0) up to 3 months post ablationSponsors and contacts
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Source ClinicalTrials.gov