Liver cancer drug shows promise in Late-Stage patients
NCT ID NCT05117957
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tested the drug sorafenib in 50 adults with advanced liver cancer that had worsened after at least one prior treatment. Participants took sorafenib daily to see if it could slow tumor growth and improve survival. The trial measured how long patients lived without their cancer getting worse and monitored side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sorafenib (a targeted cancer drug taken as a pill)
- What this could lead to
- If successful, this could provide a treatment option for patients with advanced liver cancer who have not responded to other therapies.
- What could go wrong
- This is a small, early-phase trial (50 participants) with no control group, so results may not be definitive. Sorafenib can cause side effects like fatigue, diarrhea, and skin reactions.
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
-
50 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Dec 2025
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 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 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 written informed consent 2. Age of 20 or more 3. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 4. Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies 5. Intolerant to or progressed on at least 1 prior systemic treatment for HCC 6. Having at least one measurable target lesion (per RECIST v1.1) \- Patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1. 7. Child-Pugh class A or B7 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 9. Life expectancy of at least 16 weeks 10. Adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment): 11. Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration. Exclusion Criteria: 1. Fibrolamellar carcinoma or sarcomatoid carcinoma 2. Having active brain metastasis or leptomeningeal metastasis 3. Moderate to severe or intractable ascites 4. Presence of hepatic encephalopathy 5. Presence of active bacterial infection 6. Uncontrolled severe medical comorbidity 7. 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) 8. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
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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.
Contacts and locations
Locations
-
National Cancer Center, Korea
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Immunotherapy drug durvalumab may be safe for liver cancer patients with active hepatitis b
- Immunotherapy-Targeted therapy combo shows promise for advanced liver cancer
- New drug zanzalintinib tested for advanced liver cancer
- New drug cocktail shows promise for tough liver cancer
- Promising drug cocktail targets Hard-to-Treat liver cancer