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Experimental pill aims to shield the liver during cancer treatment
NCT ID NCT06478719
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This trial tests whether an experimental drug called FB-1603 can protect liver function in people with liver cancer who are receiving a standard procedure called transarterial chemoembolization (TACE). Participants take either a low dose, a high dose, or a placebo capsule daily for 10 weeks. The study measures changes in liver enzyme levels to see if FB-1603 reduces liver damage caused by the cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental oral drug called FB-1603
- What this could lead to
- If it works, FB-1603 could help preserve liver function during chemoembolization, potentially improving outcomes for liver cancer patients.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not confirm benefit. Liver function changes are measured by blood tests, not long-term survival.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 85 years
- 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. Aged 18-85 years (inclusive) of either gender 2. Willing and able to provide signed informed consent 3. Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology 4. Subject has the willingness to undergo TACE 5. ECOG performance Status of 0-1 6. The patient is expected to survive more than 3 months 7. Laboratory values should meet all the following standards at the screening visit: A. AST, ALP and ALT are ≤ 5x ULN. B. International Normalized Ratio (INR) ≤ 1.5 C. Prothrombin time \< 4 sec above upper limit of normal D. Absolute neutrophil count ≥ 1.5×10\^9/L; Hemoglobin ≥ 9 g/dL; platelet ≥ 50×10\^9/L. E. Total bilirubin \< 2.5 mg/dL F. Serum creatinine \< 2 mg/dL 8. With liver stiffness measurement \>7 kPa (assessed by FibroScan®) or \> 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI)) Exclusion Criteria: 1. Patients with evidence of macrovascular invasion 2. Patients with evidence of extrahepatic spread 3. Any condition representing a contraindication to TACE as determined by the investigators 4. Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, and ascites 5. Patients with acute or chronic active hepatitis B or C infection and are recommended to receive HBV or HCV treatment, e.g., Patient with HBV DNA ≥ 20,000 IU/ml or with detectable HCV RNA 6. Patients who have severe organic diseases on heart, lungs, brain, kidney, and gastrointestinal tract by the judgment of investigators 7. Patients with chronic pancreatitis 8. Patients who are taking any prohibited drugs that might interfere the trial 9. Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis 10. Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit
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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
2 sites. 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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Linkou Chang Gung Memorial Hospital
RECRUITINGTaoyuan, Taiwan, 333, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan, 10002, Taiwan
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