HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer (HiQuality)
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|ClinicalTrials.gov Identifier: NCT01387932|
Recruitment Status : Terminated (The clinical study was terminated due to the inability to meet target enrollment.)
First Posted : July 6, 2011
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Device: HepaSphere/QuadraSphere Microspheres Procedure: PVA, lipiodol, doxorubicin||Phase 3|
This phase three, interventional, and prospective study consists of a patient population that has advanced liver cancer (hepatocellular cancer [HCC]) that cannot be removed by standard therapies such as surgical removal, liver transplant, and/or ablation.
Embolics and drug eluting embolics are being used by interventional radiologists to try and shrink or kill the tumor area.
Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. Subjects were randomized on a 1:1 basis (subjects were blinded to arm they were randomized to).
Post randomization and within four weeks of the first chemoembolization procedure all subjects had a baseline MRI. Following, the first chemoembolization procedure (hqTACE or cTACE) or 'cycle' was completed. Subjects can (per protocol) receive up to 3 TACE cycles. Within 4 weeks after any TACE cycle, an MRI and labs should be conducted/collected to evaluate disease status (reduction vs progression) and measure treated lesions. Any residual disease that is present after after the first TACE will undergo the next TACE cycle (maximum of three). However, if the liver MRI shows a complete response (absence of HCC) then no additional TACE procedures are performed and the subject is followed for survival.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||235 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized 1:1 to receive either 1. A Conventional TACE (Trans Arterial Chemoembolization) procedure using PVA, lipiodol and doxorubicin (cTACE), or 2. HepaSphere/QuadraSphere Microspheres loaded with doxorubicin for Trans Arterial Chemoembolization (hqTACE). Participants in both treatment arms will be followed for overall survival, the primary study endpoint.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants are blinded to the treatment they are randomized to (cTACE or hqTACE). Central Reviewers (two interventional radiologists) will evaluate study participant's liver MRIs to assess the tumor response. The Central Reviewers will be blinded to the treatment the participant received.|
|Official Title:||Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2021|
|Actual Study Completion Date :||February 2021|
Experimental: HepaSphere/QuadraSphere TACE
Device: HepaSphere/QuadraSphere Microspheres
HepaSphere/QuadraSphere Microspheres loaded with doxorubicin
Active Comparator: Conventional TACE
Procedure: PVA, lipiodol, doxorubicin
Conventional TACE procedure using PVA, lipiodol and doxorubicin
- Median Overall Survival [ Time Frame: 2 years ]Median overall survival will be calculated using the Intent-to-Treat (ITT) population in each treatment arm when the last subject has completed two years of follow up after their first study TACE procedure. Per protocol, study subjects were followed for survival until death or deemed lost to follow up. All deaths are reported within safety.
- Objective Response Rates (ORR) [ Time Frame: Study was terminated early so analysis of additional outcome(s) were not possible. ]The Objective Response Rate will be calculated for the ITT population by adding the number of participants that were determined to have complete or partial response (utilizing mRECIST criteria) and dividing by the number of ITT participants.
- Number of TACE-Related Adverse Events in Subjects Treated With HepaSphere/QuadraSphere vs Subjects Treated With Conventional TACE. [ Time Frame: 30 days ]
The number of TACE- Related adverse events experienced by subjects treated with HepaSphere/QuadraSphere will be compared to the number of TACE-related adverse events experienced by subjects treated with conventional TACE.
Adverse events were recorded for treated subjects from the date of randomization up to and including 30 days post the last study MRI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387932
|Principal Investigator:||Michael Soulen, MD||University of Pennsylvania|
|Study Chair:||Riccardo Lencioni, MD||Independent Radiology Panel|
|Study Chair:||Josep Llovet, MD||Data Safety Monitoring Board|