N/A
Completed N=33
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Carcinoma, Hepatocellular · Hepatocellular Carcinoma · Liver Cancer
Source: ClinicalTrials.gov NCT03586050 ↗
Enrolled (actual)
33
Serious AEs
21.2%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants Whose Ablation Resulted in Technical Success — 30; 30 Participants
Summary
This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Whose Ablation Resulted in Technical Success |
30; 30 | — |
| SECONDARY Number of Participants Whose Ablation Resulted in Primary Technique Efficacy |
30; 30 | — |
| SECONDARY Percentage of Participants With Local Tumor Progression (LTP) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Primary Efficacy |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Secondary Efficacy |
— | — |
| SECONDARY Progression Free Survival (PFS) Rate |
40.8; 38.5 | — |
| SECONDARY Overall Survival (OS) Rate |
90.0 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation |
66.7 | — |
| SECONDARY Percentage of Participants With Adverse Events Within 36 Months Post Ablation |
66.7 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Pain Score |
0.32; -0.01; 0.00; 0.02; 0.01; -0.03 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score |
1.23; -0.05; -0.42; 0.74; 2.23; 3.38 | — |
| SECONDARY Change From Baseline in EORTC QLQ HCC 18 Scale Score |
1.58; 1.85; 0.69; 1.36; 1.11; 3.24 | — |
| SECONDARY Health Economics: Complete Procedure Time |
19 | — |
| SECONDARY Health Economics: Total Ablation Duration |
7.76 | — |
| SECONDARY Health Economics: Median Number of Ablations |
2 | — |
| SECONDARY Health Economics: Length of Hospital Stay |
2 | — |
| SECONDARY Health Economics: Percentage of Participants With Single and Multi Probes Usage |
3.3; 96.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03586050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.