Second-line hope: regorafenib tested after lenvatinib failure in liver cancer
NCT ID NCT07514429
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug regorafenib can help people with advanced liver cancer whose disease got worse after treatment with lenvatinib. About 24 adults will receive regorafenib and be monitored for how long their cancer stays under control and for side effects. The goal is to see if this second treatment can slow the cancer's growth.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent form. 2. Age ≥ 19 years at the time of signing the informed consent form. 3. Diagnosis of hepatocellular carcinoma (HCC) confirmed histologically or clinically according to the Korean Liver Cancer Association-National Cancer Center (KLCA-NCC) guidelines. 4. Patients with unresectable HCC who have experienced disease progression or treatment discontinuation due to toxicity during prior treatment with lenvatinib. 5. Presence of at least one measurable target lesion according to RECIST v1.1. 6. Child-Pugh classification A or B7 (score 7). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 8. Adequate hematologic and end-organ function defined by the following laboratory test results obtained within 14 days prior to testing (or enrollment): * Hemoglobin ≥ 8.5 g/dL * Absolute neutrophil count (ANC) ≥ 1,200/mm³ * Platelet count ≥ 60,000/μL * Total bilirubin \< 3.5 mg/dL * Serum albumin ≥ 2.5 g/dL * AST and ALT ≤ 7 × upper limit of normal (ULN) * Prothrombin time (INR ≤ 1.8 × ULN) * Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault equation) 9. Virological status of hepatitis confirmed and recorded through HBV and HCV screening. * Participants with HBV or HCV infection must be receiving antiviral therapy according to institutional guidelines. 10. Women of childbearing potential must agree to maintain abstinence or use effective contraception (with an annual failure rate of \< 1%) from the time of signing the informed consent until at least 6 months after the last dose of the study drug. Male participants must agree to maintain abstinence or use effective contraception (with an annual failure rate of \< 1%) and refrain from sperm donation from the time of signing the informed consent until at least 6 months after the last dose of the study drug. Exclusion Criteria: 1. Albumin-bilirubin (ALBI) grade 3. 2. Fibrolamellar carcinoma or sarcomatoid carcinoma. 3. Prior treatment with regorafenib. 4. History of allogeneic stem cell transplantation or solid organ transplantation. 5. Active brain metastases or leptomeningeal metastases. 6. History of malignancy other than hepatocellular carcinoma (HCC) within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year survival rate \> 90%). 7. Severe cardiovascular disease within 3 months prior to the start of study therapy (e.g., New York Heart Association \[NYHA\] Class II or higher heart disease, myocardial infarction, or cerebrovascular accident); uncontrolled serious medical comorbidities, including unstable arrhythmia or unstable angina; or other significant medical conditions or abnormal findings that, in the opinion of the investigator, may increase the risk associated with study participation. 8. Female participants who are pregnant or breastfeeding, or male or female participants of reproductive potential who are unwilling to use effective contraception from screening until 6 months after the last dose of the study drug. 9. Participants deemed by the investigator to be unlikely to comply with study procedures, restrictions, and requirements. 10. Patients who have received locoregional therapy (e.g., radiofrequency ablation \[RFA\], microwave ablation \[MWA\], transarterial chemoembolization \[TACE\], transarterial radioembolization \[TARE\], transarterial embolization \[TAE\], radiation therapy, etc.) after discontinuation of lenvatinib treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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