Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

Number of participants whose ablation resulted in technical success were reported. Technical success was defined as complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced Magnetic resonance imaging (MRI) and Computed scans immediately following the ablation procedure on Day 0 evaluated by the independent reviewer and principle investigator (PI) based on the response to the question Confirm outcome of ablation.

Time frame: Post ablation procedure (Day 0) up to 4 days

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Change from baseline in EORTC QLQ HCC 18 scale score were reported. EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) was an 18-multi-item scales which were grouped into 8 symptom scales such as fatigue, body image, jaundice, nutrition, pain, fever, abdominal swelling and sex life. All scales were grouped and converted to scores of 0 to 100 according to the scoring manual; a higher score represented a more severe symptom or problem. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement.

Time frame: Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Change from baseline in EORTC QLQ-C30 scale score were reported. EORTC QLQ-C30 contains 30 questions for assessing overall health in cancer patients. The questions reflect how patients felt during the past week and are scored 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) except for the last two questions, which are scored on a 7-point Likert Scale from 1-7 (1=very poor to 7=excellent). All the questions were transformed to a 0-100 scale and summed for an overall quality of life score, with a high score representing higher quality of life. Baseline: last non-missing measurement prior to date of first microwave ablation or on date of first microwave ablation but prior to time of first probe placement.

Time frame: Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Change from baseline in VAS pain scores were reported. VAS pain score was a self-reported pain score on a 100 millimeter (mm) scale which ranged from ranged from 0 mm (no pain) to 100 mm (severe pain). Higher score indicated severe pain. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement.

Time frame: Baseline (Pre-Ablation), Day 0 (post ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Complete procedure time was defined as the time between the first probe placement and the last probe removal.

Time frame: Day 0 (On day of ablation treatment)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Length of hospital stay were reported. Length of hospital stay was defined as the time from procedure completion to hospital discharge.

Time frame: Day 0 (On day of ablation treatment) up to 30 days (1-month post ablation visit)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

The median number of ablations was reported.

Time frame: Day 0 (On the day of ablation treatment)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Percentage of participants with single and multiple probes usage were reported. PR and LK probes were used at least once.

Time frame: Day 0 (On the day of ablation treatment)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Total ablation duration were reported.

Time frame: Day 0 (On the day of ablation treatment)

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Number of participants whose ablation resulted in primary technique efficacy were reported. Primary technique efficacy was defined as a complete tumor ablation with adequate or insufficient ablation margin, based on contrast-enhanced MRI and CT scans follow-up at 1 month after the ablation procedure, evaluated by the independent reviewer and PI based on the response to the question Confirm outcome of ablation. The primary technique efficacy was achieved if responses were either Complete tumor ablation with adequate margin or Complete tumor ablation with insufficient margin.

Time frame: At 1 month after the ablation procedure on Day 0

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

OS rate was defined as the percentage of participants with OS. OS was defined as the time from the first ablation until death due to any cause.

Time frame: At 36 months after the ablation procedure on Day 0

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

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 ablation

Population: Safety analysis set (SAF) included all participants in whom the microwave ablation procedure was attempted, that is, started and regardless of whether it got completed as planned or not.

Percentage of participants with AEs within 36 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 36 months post ablation

Population: SAF included all participants in whom the microwave ablation procedure was attempted, that is, started and regardless of whether it got completed as planned or not.

Percentage of participants with LTP were reported. The first LTP rate was defined as one minus primary efficacy rate. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of local tumor progression (LTP) based on the independent reviewer's assessment and PI assessment.

Time frame: At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Percentage of participants with primary efficacy based on the independent reviewer and PI assessment were reported. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of LTP based on the independent reviewer's assessment and PI assessment.

Time frame: At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.

Percentage of participants with secondary efficacy based on the independent reviewer and PI assessment were reported. Secondary efficacy rate was defined as percentage of participants with target tumors that had undergone successful repeat ablation following identification of local tumor progression.

Time frame: From time of first ablation (Day 0) up to 36 months

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. Data for this outcome measure was not collected and analyzed as no participant had undergone repeat ablations.

PFS rate was defined as the percentage of participants with PFS. PFS was defined as the time from the first ablation until LTP (first LTP rate was defined as one minus primary efficacy rate), any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first). PFS rate based on independent reviewer's assessment and PI assessment was reported.

Time frame: At 36 months after the ablation procedure on Day 0

Population: FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. Here N (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number analyzed) signifies the number of participants analyzed for specified categories.