A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin (NCT02141906) | Clinical Trial Compass
CompletedPhase 2
A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin
United States20 participantsStarted 2015-01-21
Plain-language summary
This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a diagnosis of Hepatocellular carcinoma confirmed by at least one of the following: a) histological confirmation; b) imaging results consistent with cirrhosis and at least one solid liver lesion of \>2cm with early enhancement and delayed washout (AASLD criteria for diagnosis of HCC); c) Alpha fetoprotein level \>400ng/mL and evidence of at least one solid liver lesion \>2cm, regardless of specific imaging characteristics on MRI.
* Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed)
* Age ≥ 18 years.
* Performance status ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status).
* Child Pugh Score A only
* Adequate organ and marrow function as defined below:
* leukocytes ≥ 3,000/mcL (Measurement and Calibration Lab)
* absolute neutrophil count ≥ 1,500/mcL
* platelets ≥ 75,000/mcl
* total bilirubin ≤ 3.0
* AST (Aspartate Aminotransferase)(SGOT)/ALT (Alanine Aminotransferase)(SPGT) ≤ 5 X institutional upper limit of normal
* creatinine ≤ 2.0
* INR (International Normalized Ratio) ≤ 1.8
* Albumin ≥ 2.8
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response
Timeframe: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks.
Trial details
NCT IDNCT02141906
SponsorUniversity of Texas Southwestern Medical Center