HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China
NCT ID: NCT02743065
Last Updated: 2018-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2016-09-30
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TACE-HAIC vs. HAIC for Potentially Resectable HCC
NCT03591705
Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients
NCT03273608
Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma
NCT00493402
The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
NCT05862181
DEB-TACE+HAIC vs. HAIC for Large HCC
NCT05263219
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Device: HepaSphere Microspheres
HepaSphere Microsphere
HepaSphere with 50-75mg Doxorubicin
HepaSphere with 50-75mg Doxorubicin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HepaSphere with 50-75mg Doxorubicin
HepaSphere with 50-75mg Doxorubicin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hong Shan
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hong Shan, MD
Role: PRINCIPAL_INVESTIGATOR
Fifth Affiliated Hospiatl, Sun Yet-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Mingsheng Huang, MD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ning Yang, MD
Role: primary
Hong Shan, MD
Role: primary
Long Fei Peng, MD
Role: backup
Xiaofeng He, MD
Role: primary
Mingsheng Huang, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEPA-China-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.