Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer (NCT01624285) | Clinical Trial Compass
CompletedPhase 2
Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
United States20 participantsStarted 2012-07-16
Plain-language summary
The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high risk patients following liver transplantation
Who can participate
Age range
19 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 hepatocellular carcinoma (HCC) with one of the following on explant: microvascular/macrovascular invasion, tumor outside of Milan criteria, poor tumor differentiation; patients with macrovascular invasion on explant pathology will be stratified
\* Additionally, the following will be included
\*\* Patients with elevated surrogate markers (AFP \> 500 or PIVKA \> 400) pre transplant and with biopsy proven HCC prior to orthotopic liver transplantation (OLT) or on explant
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Patients with a life expectancy \> 12 weeks
* Patients must have completed prednisone taper within 6 weeks post OLT
* Patients must be enrolled between 6 to 12 weeks post OLT
* Cadaveric donors only (no living donor liver transplantation \[LDLT\] or donor after cardiac death transplantation \[DCDT\])
* No sorafenib prior to inclusion in the study
* Platelet count \> 50 x 10\^9/L
* Hemoglobin \>= 8.5 g/dL
* Total bilirubin =\< 5 mg/dL
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) =\< 5 x upper limit of normal
* Amylase and lipase =\< 1.5 x the upper limit of normal
* Serum creatinine \< 2 x the upper limit of normal
* Prothrombin time (PT) =\< 6 seconds or international normalized ratio (INR) =\< 2.3
* AFP \> 500 (pre-transplant)
* PIVKA \> 400 (pre-transplant)
* Patient has not received prior anti-angiogenic therapy, systemic targeted agents or systemic chemotherapy
\* P…
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
Recurrence-free survival, evaluated using the new international criteria proposed by the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Committee
Timeframe: Defined as the time from randomization to the first documented disease recurrence by radiological assessment or death due to any cause whichever occurs first, assessed at 2 years