HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China

Superselective Drug-Eluting Chemoembolization With HepaSphere in Unresectable Advanced HCC Patients: Safety & Efficacy Registry in China (SUPER-China)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02743065

Acronym

SUPER-China

Enrollment

100

Registered

2016-04-19

Start date

2016-09-30

Completion date

2019-12-31

Last updated

2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

HepaSphere

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

Interventions

DEVICEHepaSphere with 50-75mg Doxorubicin

HepaSphere with 50-75mg Doxorubicin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 or older 2. Patient has signed informed consent 3. Patient must have a diagnosis of hepatocellular cancer by at least one of the following method: 1. Histological confirmation 2. 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. 4. At time of study entry. 1. Patients not suitable for ablation due to lesion location may be enrolled 2. Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled 5. 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 6. Patient has a life expectancy of at least 6 months

Exclusion criteria

1. Current or previous treatment with chemo- or radiation therapy or sorafenib 2. Previous treatment of transarterial chemoembolization (TACE) 3. Patients with current or history of any other cancer except non-melanomatous skin cancer 4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive 5. Performance status ECOG \> 2 6. Child-Pugh Class C 7. Occlusive tumor thrombus to the main portal trunk 8. Active gastrointestinal bleeding 9. Evidence of uncorrectable bleeding diathesis 10. Extra-Hepatic spread of the HCC 11. \>50% tumor involvement of the liver 12. Infiltrative HCC 13. Encephalopathy not adequately controlled medically 14. Presence of ascites not controlled medically 15. Any contraindication for MRI/ CT (eg. metallic implants) 16. Allergy to contrast media that cannot be managed with prophylaxis 17. Any contraindication to arteriography 18. Any contraindication for doxorubicin administration

Design outcomes

Primary

Measure	Time frame
Adverse Events	2- years
Progress-free-survival (PFS)	2-years

Secondary

Measure	Time frame
Overall Survival	2-years
Objective Response Rates	6-months

Countries

China

Contacts

Primary ContactMingsheng Huang, MD

+86 020 85252066

Backup ContactJunwei Chen

aaronchan83@163.com+86 020 85252066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026