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Hepatocellular CarcinomaNCT03273608

Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients

An observational study of Hepatocellular Carcinoma, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatocellular Carcinoma
How many people
120 participants
Where
1 siteTaiwan
Study dates
14 Sep 2016to 30 Sep 2019
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Inclusion Criteria:Patients must meet all of the following inclusion criteria in order to be entered into the study:

  • 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.

Exclusion Criteria:If patients meet any of the following criteria they may not be entered into the study:

  • 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.
  • Any contraindication for hepatic embolization. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization. Hepatofugal blood flow. Serum creatinine > 2mg/dL. Other condition deemed exclusionary by physician. Uncorrectable impaired clotting.

Trial locations and contacts

1 site in 1 country.

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

+886-2-28757506

yhhhuang@vghtpe.gov.tw

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Yi-Hsiang Huang, M.D. Ph.D., +886-2-28757506, yhhuang@vghtpe.gov.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients: Safety & Efficacy Registry in Taiwan (SUPER- Taiwan)

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.

Read the detailed description

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 on deTACE in HCC management to physicians in the region, and to support the application of in treating advanced HCC patients.

  1. Primary Objective: To collect 1-year overall survival of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients in Taiwan.
  2. Secondary Objectives:
  3. To evaluate the overall tumor response of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients. The tumor response is according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
  4. To evaluate the local tumor response (in the tumor(s) treated with drug-eluting microsphere) by chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
  5. To evaluate the safety profile of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
  6. Exploratory Objectives:
  7. To evaluate the downstaging and downsizing potential of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients to within Milan Criteria and to within Resection margin.
  8. To collect time-to-progression (TTP) and progress-free-survival (PFS) data of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
Keywords
Hepatocellular Carcinoma, Advanced HCC, Unresectable, deTACE, HepaSphere
Medical subject headings
Carcinoma, Hepatocellular

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (2)

  1. Tumor Response

    Tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis under CT/ MRI and will be presented as %.

    Measured: 1 year

  2. Adverse Event (AE)

    Adverse event will be accessed according to CTCAE 4.0 after treatments until end of study or death.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2017
  2. Study start14 Sep 2016
  3. Primary completion30 Sep 2019 (estimated)
  4. Study completion30 Sep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
120 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03273608
Sponsor's protocol ID
HEPA-Taiwan-001
Status last verified
Sep 2017
First submitted
4 Aug 2017
Last updated
6 Sep 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yi-Hsiang Huang, M.D. Ph.D. (+886-2-28757506, yhhhuang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03273608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.

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