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

Ethicon, Inc.33 enrolled

Overview

This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.

This prospective, single-arm single center study will provide clinical data for the Neuwave Medical Microwave Ablation System and accessories. Individuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled. The enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis. The subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular Hepatocellular Carcinoma Hepatocellular Cancer Cancer, Hepatocellular

Interventions

Microwave ablationDEVICE

All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation 2. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only; 3. Scheduled for microwave ablation of the liver; 4. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 5. Functional hepatic reserve based on the Child-Pugh score (Class A or B); 6. American Society of Anesthesiologists (ASA) score \< 3; 7. Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule; 8. At least 19 years of age Exclusion Criteria: 1. Active bacterial infection or fungal infection; 2. Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure; 3. Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure; 4. Subject with implantable pacemakers or other electronic implants; 5. Planned/ scheduled liver surgery. 6. Subject with a platelet count of less than 20,000/mm3; 7. Subject with an INR greater than 1.5; 8. Subject with renal failure on renal dialysis; 9. Scheduled concurrent procedure other than microwave ablation in the liver; 10. Pregnant or lactating; 11. Physical or psychological condition which would impair study participation; 12. Participation in any other clinical study concurrently or within the last 3 months; 13. The subject is judged unsuitable for study participation by the Investigator for any other reason; 14. Unable or unwilling to attend follow-up visits and examinations.

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants Whose Ablation Resulted in Technical Success

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

Secondary Outcomes

Number of Participants Whose Ablation Resulted in Primary 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

Percentage of Participants With Local Tumor Progression (LTP)

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

Percentage of Participants With Primary Efficacy

Data from ClinicalTrials.gov

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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

Percentage of Participants With Secondary 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

Progression Free Survival (PFS) Rate

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

Overall Survival (OS) Rate

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

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 ablation

Percentage of Participants With Adverse Events Within 36 Months Post Ablation

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

Change From Baseline in Visual Analogue Scale (VAS) Pain Score

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)

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score

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)

Change From Baseline in EORTC QLQ HCC 18 Scale Score

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)

Health Economics: Complete Procedure Time

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)

Health Economics: Total Ablation Duration

Total ablation duration were reported.

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

Health Economics: Median Number of Ablations

The median number of ablations was reported.

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

Health Economics: Length of Hospital Stay

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)

Health Economics: Percentage of Participants With Single and Multi Probes Usage

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)