Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma (NCT06138769) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma
South Korea50 participantsStarted 2023-07-20
Plain-language summary
Although atezolizumab-bevacizumab has been positioned as the standard first-line therapy in unresectable heptocellular carcinoma, eventually most patients progressed on this regimen. Despite of multiple drugs are approved for the management of unresectable hepatocellular carcinoma, only a few trials have been conducted to investigate their efficacy in the second-line setting after the progression on atezolizumab-bevacizumab. Lenvatinib is approved first-line multikinase inhibitor in unresectable hepatocellular carcinoma, but has not yet been investigated as second-line therapy in prospective study. In this single arm phase 2 study, the efficacy and safety of lenvatinib will be investigated for patients who progressed on first-line atezolizumab-bevacizumab.
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
. Diagnosis of HCC according to AASLD guidelines
. Disease that is not amenable to a curative treatment (e.g. surgery, transplant, radiofrequency ablation)
. Prior treatment with atezolizumab plus bevacizumab as first-line treatment for unresectable HCC
. Progression after atezolizumab plus bevacizumab, the duration of these treatments must be 2 consecutive treatment cycles or more.
. At least 1 RECIST v1.1 measurable untreated lesion
. Recovery to ≤ Grade 1 from toxicities related to any prior treatments, unless the adverse events are clinically non-significant and/or stable on supportive therapy
. Life expectancy of 12 weeks or longer
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.
. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
. Prior lenvatinib treatment
. Prior systemic treatment for HCC, except for atezolizumab plus bevacizumab (i.e. lenvatinib must be second-line systemic treatment)
. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization.
. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
. Major surgery within 2 months before randomization. Complete healing from major surgery must have occurred 1 month before randomization. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before registration. Subjects with clinically relevant co d. Cavitating pulmonary lesion(s) or endobronchial disease
. Moderate or severe ascites (Radiologically detected but clinically insignificant ascites is allowed)
. Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 21 days of registration