NCT03273608

Brief Summary

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence in HCC management to physicians in the region, and to support the application of deTACE in treating advanced HCC patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 14, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

August 4, 2017

Last Update Submit

September 4, 2017

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaAdvanced HCCUnresectabledeTACEHepaSphere

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    To define all participants from the day of the first HepaSphere Treatment until end of study or death is reported, whichever comes first.

    1 year

Secondary Outcomes (2)

  • Tumor Response

    1 year

  • Adverse Event (AE)

    1 year

Other Outcomes (2)

  • Exploratory Objectives, Time-To-Progression (TTP)

    1 year

  • Exploratory Objectives, Downstaging

    1 year

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients.

You may qualify if:

  • Age 20 or older.
  • Patient has signed informed consent.
  • Patient must have a diagnosis of hepatocellular cancer confirmed by AASLD and at least one of the following method:
  • Magnetic resonance imaging (MRI) with early enhancement and delayed enhancement washout of at least one solid liver lesion \> 1 cm.
  • Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion \> 1 cm.
  • Histological confirmation is required for lesions with inconclusive features.
  • Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.
  • Patients not suitable for ablation due to lesion location may be enrolled.
  • Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled.
  • Patient MUST be with either BCLC stage B OR C, and meet the following criteria:
  • Stage Child-Pugh A or B AND
  • Performance status ECOG ≤ 1 WITH Vascular Invasion or WITHOUT Vascular invasion.
  • Patient has a life expectancy of at least 6 months.

You may not qualify if:

  • Current or previous treatment with chemo- or radiation therapy or sorafenib or drug-eluting chemoembolization (deTACE).
  • Patients with concurrent cancer except non-melanomatous skin cancer.
  • Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive.
  • Performance status ECOG \> 1.
  • Child-Pugh Class C.
  • Occlusive tumor thrombus to the main portal trunk.
  • Active gastrointestinal bleeding.
  • Evidence of uncorrectable bleeding diathesis.
  • Extra-Hepatic spread of the HCC.
  • Encephalopathy not adequately controlled medically.
  • Presence of ascites not controlled medically.
  • Any contraindication for MRI/ CT (eg. metallic implants).
  • Allergy to contrast media that cannot be managed with prophylaxis.
  • Any contraindication to arteriography.
  • Any contraindication for doxorubicin administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yi-Hsiang Huang, M.D. Ph.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Hsiang Huang, M.D. Ph.D.

CONTACT

+886-2-28757506yhhhuang@vghtpe.gov.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Yi-Hsiang Huang

Study Record Dates

First Submitted

August 4, 2017

First Posted

September 6, 2017

Study Start

September 14, 2016

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

TW(1)