Not Yet RecruitingPhase 2

Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE)

South Korea146 participantsStarted 2026-04

Plain-language summary

The goal of this clinical trial is to learn if lenvatinib or regorafenib can help treat people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed with surgery after first treatment with immunotherapy-based drug combinations. It will also look at the safety of these treatments. The main questions this study aims to answer are: * How long lenvatinib can delay cancer growth in people with good liver function (Child-Pugh)A after dual immunotherapy * How long people with reduced liver function (Child-Pugh B7-B8) live after treatment with lenvatinib or regorafenib after first-line immunotherapy-based combination treatment * What side effects people experience during treatment * How many people have their tumors shrink or disappear The study has two parts: In REVIVE-1, participants with Child-Pugh A liver function will receive lenvatinib. In REVIVE-2, participants with Child-Pugh B7 to B8 liver function will receive either lenvatinib or regorafenib. Participants will: * take lenvatinib or regorafenib by mouth * visit the clinic regularly for physical exams, blood and urine tests, and safety checks * have computed tomography (CT) scans every 8 weeks to check their cancer * be followed during and after treatment to assess outcomes and side effects

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: * Age 19 years or older * Diagnosis of hepatocellular carcinoma according to the American Association for the Study of Liver Diseases (AASLD) guidelines * Unresectable or metastatic hepatocellular carcinoma not amenable to curative treatments such as surgical resection, liver transplantation, or local ablation * Prior first-line systemic treatment with an immune checkpoint inhibitor-based combination regimen, defined as dual immune checkpoint inhibitor therapy (e.g., nivolumab plus ipilimumab or durvalumab plus tremelimumab) for the REVIVE-1 cohort, and immune checkpoint inhibitor-based combination therapy (e.g., atezolizumab plus bevacizumab, durvalumab plus tremelimumab, nivolumab plus ipilimumab, camrelizumab plus rivoceranib, or similar regimens) for the REVIVE-2 cohort; prior participation in clinical trials using these regimens is allowed * Radiologic disease progression after at least 2 cycles of first-line treatment * At least one measurable lesion according to RECIST v1.1 * Recovery from toxicities related to prior therapy to grade 1 or lower, except for clinically stable or non-clinically significant toxicities * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 12 weeks * Absolute neutrophil count ≥ 1.0 × 10⁹/L * Platelet count ≥ 75 × 10⁹/L for REVIVE-1 or ≥ 50 × 10⁹/L for REVIVE-2 * Hemoglobin ≥ 9 g/dL * Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL/min * Proteinuria \<3 g in 24…

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

Progression-Free Survival (PFS) in REVIVE-1

Timeframe: Up to 24 months

Overall Survival (OS) in REVIVE-2

Timeframe: Up to 30 months

Trial details

NCT IDNCT07495579

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Changhoon Yoo

82-2-3010-1727 cyoo.amc@gmail.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma (HCC) trials