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

Hepatocellular Carcinoma Clinical Trial

— SUPER-China  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02743065
• Other study ID #: HEPA-China-002
• Status: Recruiting
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Mingsheng Huang, MD
• Phone: +86 020 85252066
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• HepaSphere with 50-75mg Doxorubicin
HepaSphere with 50-75mg Doxorubicin

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Fifth Affiliated Hospiatl, Sun Yet-Sen University	Guangzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Third Affiliated Hospiatl, Sun Yet-Sen Hospital	Guangzhou
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University	Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		2- years
Primary	Progress-free-survival (PFS)		2-years
Secondary	Overall Survival		2-years
Secondary	Objective Response Rates		6-months