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

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: HepaSphere with 50-75mg Doxorubicin

• Registration Number: NCT02743065
• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Study Start: 2016-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-20
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: HepaSphere Microspheres	HepaSphere with 50-75mg Doxorubicin	HepaSphere Microsphere

Primary Outcome Measures

Name	Time	Method
Adverse Events	2- years
Progress-free-survival (PFS)	2-years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2-years
Objective Response Rates	6-months

Trial Locations

Locations (6)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China

Fifth Affiliated Hospiatl, Sun Yet-Sen University; 🇨🇳 Guangzhou, China

Third Affiliated Hospiatl, Sun Yet-Sen Hospital; 🇨🇳 Guangzhou, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China