NCT03063840

Brief Summary

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

January 4, 2017

Last Update Submit

November 18, 2020

Conditions

Liver Cancer

Keywords

hepatocellular carcinomamicrowave ablationliver cancer

Outcome Measures

Primary Outcomes (1)

  • tumor evaluation

    Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).

    1 month after treatment

Secondary Outcomes (5)

  • Eastern Cooperative Oncology Group (ECOG) evaluation

    up to two years

  • Clinical laboratory assessment

    up to two years

  • Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation

    up to two years

  • Review concomitant medications

    up to two years

  • Assess for presence of adverse events

    up to two years

Study Arms (1)

Microwave ablation (MWA)

EXPERIMENTAL

Microwave ablation (MWA)

Device: Microwave ablation

Interventions

Microwave ablationDEVICE

Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator

Microwave ablation (MWA)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm.
  • Have at least one, but less than or equal to 3 tumors.
  • Each tumor must be ≤ 5 cm in diameter.
  • Child-Pugh class A-B.
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1.
  • American Society of Anaesthesiologists (ASA) score ≤ 3.
  • Adequate bone marrow and liver function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 2 mg/dL(3). alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal (4). prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0.
  • The disease status is not suitable to receive transarterial chemoembolization or other standard treatment.
  • Prior Informed Consent Form.
  • Life expectancy of at least 3 months.

You may not qualify if:

  • Patients presenting with any of the following will not be enrolled into this study:
  • Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
  • Received treatment with an investigational agent/ procedure within 30 days prior to microwave ablation.
  • Patients who cannot tolerate radiofrequency ablation (RFA) procedure.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Concurrent extrahepatic cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Kai-Wen Huang, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

January 4, 2017

First Posted

February 24, 2017

Study Start

July 1, 2016

Primary Completion

May 1, 2018

Study Completion

July 27, 2018

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share