Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study (NCT05117957) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study
South Korea50 participantsStarted 2022-03-08
Plain-language summary
To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC.
Who can participate
Age range
20 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
. Signed written informed consent
. Age of 20 or more
. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center
. Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies
. Intolerant to or progressed on at least 1 prior systemic treatment for HCC
. Having at least one measurable target lesion (per RECIST v1.1)
. Child-Pugh class A or B7
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Exclusion criteria
. Fibrolamellar carcinoma or sarcomatoid carcinoma
. Having active brain metastasis or leptomeningeal metastasis
. Moderate to severe or intractable ascites
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
Progression-free survival (PFS)
Timeframe: Until 12 months after the last patient was enrolled
2
Safety (Adverse events)
Timeframe: Until 12 months after the last patient was enrolled
. Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study