Clinical trial NCT02743065: HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China
Official title: Superselective Drug-Eluting Chemoembolization With HepaSphere in Unresectable Advanced HCC Patients: Safety & Efficacy Registry in China (SUPER-China)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: HepaSphere
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2016-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Advanced Hepatocellular Carcinoma (HCC)

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


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 2- years
measure: Progress-free-survival (PFS)
timeFrame: 2-years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2-years
measure: Objective Response Rates
timeFrame: 6-months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Guangzhou
country: China
facility: Fifth Affiliated Hospiatl, Sun Yet-Sen University
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: Third Affiliated Hospiatl, Sun Yet-Sen Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fifth Affiliated Hospiatl, Sun Yet-Sen University
name: Hong Shan, MD
role: PRINCIPAL_INVESTIGATOR
References: