Clinical trial NCT03586050: Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Official title: A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Hepatocellular Carcinoma
Hepatocellular Cancer
Cancer, Hepatocellular
Keywords: Hepatocellular Carcinoma; liver cancer; cancer; liver
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Whose Ablation Resulted in Technical Success
timeFrame: Post ablation procedure (Day 0) up to 4 days
Secondary outcomes:
measure: Number of Participants Whose Ablation Resulted in Primary Technique Efficacy
timeFrame: At 1 month after the ablation procedure on Day 0
measure: Percentage of Participants With Local Tumor Progression (LTP)
timeFrame: At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0
measure: Percentage of Participants With Primary Efficacy
timeFrame: At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0
measure: Percentage of Participants With Secondary Efficacy
timeFrame: From time of first ablation (Day 0) up to 36 months
measure: Progression Free Survival (PFS) Rate
timeFrame: At 36 months after the ablation procedure on Day 0
measure: Overall Survival (OS) Rate
timeFrame: At 36 months after the ablation procedure on Day 0
measure: Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation
timeFrame: From time of first ablation (Day 0) up to 3 months post ablation
measure: Percentage of Participants With Adverse Events Within 36 Months Post Ablation
timeFrame: From time of first ablation (Day 0) up to 36 months post ablation
measure: Change From Baseline in Visual Analogue Scale (VAS) Pain Score
timeFrame: Baseline (Pre-Ablation), Day 0 (post ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score
timeFrame: Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)
measure: Change From Baseline in EORTC QLQ HCC 18 Scale Score
timeFrame: Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)
measure: Health Economics: Complete Procedure Time
timeFrame: Day 0 (On day of ablation treatment)
measure: Health Economics: Total Ablation Duration
timeFrame: Day 0 (On the day of ablation treatment)
measure: Health Economics: Median Number of Ablations
timeFrame: Day 0 (On the day of ablation treatment)
measure: Health Economics: Length of Hospital Stay
timeFrame: Day 0 (On day of ablation treatment) up to 30 days (1-month post ablation visit)
measure: Health Economics: Percentage of Participants With Single and Multi Probes Usage
timeFrame: Day 0 (On the day of ablation treatment)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyunchul Rhim, MD
role: PRINCIPAL_INVESTIGATOR
References: