NCT02743065

Brief Summary

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in advanced HCC patients treated with HepaSphere in China in order to evaluate the application of HepaSphere 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

April 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

April 15, 2016

Last Update Submit

September 19, 2018

Conditions

Hepatocellular Carcinoma

Keywords

HepaSphere

Outcome Measures

Primary Outcomes (2)

  • Adverse Events

    2- years

  • Progress-free-survival (PFS)

    2-years

Secondary Outcomes (2)

  • Overall Survival

    2-years

  • Objective Response Rates

    6-months

Study Arms (1)

Device: HepaSphere Microspheres

HepaSphere Microsphere

Device: HepaSphere with 50-75mg Doxorubicin

Interventions

HepaSphere with 50-75mg DoxorubicinDEVICE

HepaSphere with 50-75mg Doxorubicin

Also known as: Superaborbent Polymer Microsphere
Device: HepaSphere Microspheres

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with Advanced Hepatocellular Carcinoma (HCC)

You may qualify if:

  • Age 18 or older
  • Patient has signed informed consent
  • Patient must have a diagnosis of hepatocellular cancer by at least one of the following method:
  • Histological confirmation
  • Classic imaging characteristics of HCC: Early enhancement (Arterial hypervascularity) and Venous or Delayed phase washout in multidetector contrast enhanced computed tomography (CT) scan / dynamic contrast-enhanced magnetic resonance imaging (MRI) imaging.
  • Either CT/ MRI shows at least one solid liver lesion ≥ 2 cm with the above described imaging characteristics of HCC.
  • In case of liver lesion between 1 and 2 cm, both CT and MRI imaging have to be performed in order to confirm the imaging characteristics of HCC.
  • 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 BCLC stage C and meet the following criteria:
  • Stage Child-Pugh A or B AND
  • Performance status ECOG ≤ 2 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
  • Previous treatment of transarterial chemoembolization (TACE)
  • Patients with current or history of any other 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 \> 2
  • 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
  • \>50% tumor involvement of the liver
  • Infiltrative HCC
  • Encephalopathy not adequately controlled medically
  • Presence of ascites not controlled medically
  • Any contraindication for MRI/ CT (eg. metallic implants)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cancer Hospital Chinese Academy of Medical Science

Beijing, China

ACTIVE NOT RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Fifth Affiliated Hospiatl, Sun Yet-Sen University

Guangzhou, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

Third Affiliated Hospiatl, Sun Yet-Sen Hospital

Guangzhou, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

ACTIVE NOT 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

  • Hong Shan, MD

    Fifth Affiliated Hospiatl, Sun Yet-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingsheng Huang, MD

CONTACT

+86 020 85252066

Junwei Chen

CONTACT

+86 020 85252066aaronchan83@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 19, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

CN(6)