Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Second-line hope: regorafenib tested after lenvatinib failure in liver cancer

NCT ID NCT07514429

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Carcinoma, hepatocellular are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asan Medical Center

    Seoul, 05505, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.