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

NCT03586050 | Completed Results FDA Device

• 1 other identifier: NEU_2017_01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular; Hepatocellular Carcinoma; Hepatocellular Cancer; Cancer, Hepatocellular

Keywords

Hepatocellular Carcinoma; liver cancer; cancer; liver

Outcome Measures

Primary Outcomes (1)

• 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".

  Post ablation procedure (Day 0) up to 4 days

Secondary Outcomes (16)

• Number of Participants Whose Ablation Resulted in Primary Technique Efficacy

  At 1 month after the ablation procedure on Day 0

• Percentage of Participants With Local Tumor Progression (LTP)

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

• Percentage of Participants With Primary Efficacy

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

• Percentage of Participants With Secondary Efficacy

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

• Progression Free Survival (PFS) Rate

  At 36 months after the ablation procedure on Day 0

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

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

Device: Microwave ablation

Interventions

Microwave ablation DEVICE

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

Microwave Ablation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only;
• Scheduled for microwave ablation of the liver;
• Performance status 0-1 (Eastern Cooperative Oncology Group classification);
• Functional hepatic reserve based on the Child-Pugh score (Class A or B);
• American Society of Anesthesiologists (ASA) score \< 3;
• 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;
• At least 19 years of age

You may not qualify if:

• Active bacterial infection or fungal infection;
• Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure;
• Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure;
• Subject with implantable pacemakers or other electronic implants;
• Planned/ scheduled liver surgery.
• Subject with a platelet count of less than 20,000/mm3;
• Subject with an INR greater than 1.5;
• Subject with renal failure on renal dialysis;
• Scheduled concurrent procedure other than microwave ablation in the liver;
• Pregnant or lactating;
• Physical or psychological condition which would impair study participation;
• Participation in any other clinical study concurrently or within the last 3 months;
• The subject is judged unsuitable for study participation by the Investigator for any other reason;
• Unable or unwilling to attend follow-up visits and examinations.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Jaclyn Calia Stanziola
• Organization: ETHICON

jcalia@its.jnj.com

908-808-6380

Study Officials

• Hyunchul Rhim, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: July 13, 2018
• Study Start: December 11, 2017
• Primary Completion: May 21, 2020
• Study Completion: May 11, 2023
• Last Updated: July 24, 2024
• Results First Posted: August 23, 2021

Record last verified: 2024-06

Locations

KR (1)