Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed by laboratory testing of tissue or cells, and who have not received any treatment for this cancer before surgery (including chemotherapy, targeted therapy, immunotherapy, radiation, or procedures to the affected area)
• People who had surgery to remove the cancer within the first 8 weeks, where the surgeon successfully removed all visible cancer with clear margins, and where a scan taken at least 4 weeks after surgery confirms no remaining cancer
• People with an ECOG performance score of 0 or 1 — meaning they are fully active or have only minor limitations in physical activity (confirm with trial site)
• People who have at least one of the following features that suggest a higher risk of the cancer returning: a single tumour larger than 5 cm; cancer found in nearby blood vessels; three or more tumours at the same time; a more aggressive tumour grade (Edmondson III–IV); or a surgical margin of 1 cm or less
• People whose AFP blood marker (a protein sometimes elevated in liver cancer) was high before surgery and has meaningfully dropped after surgery with no rising trend
• People with Hepatitis B or C who are already on, and will continue, standard antiviral treatment throughout the study period
• People whose blood counts, liver, kidney, and clotting function results fall within the ranges required by the trial (confirm specific values with trial site)
• People with a life expectancy of more than 12 months
• People who are not pregnant

Who may not be able to join:

• People whose scans after surgery show the cancer has spread outside the liver, or that cancer remains or has come back
• People who have already received additional treatment such as chemoembolisation (a procedure that delivers chemotherapy directly to liver tumours) after their surgery
• People with more advanced liver disease classified as Child-Pugh grade B or C, or who have a history of hepatic encephalopathy (a condition where the liver cannot properly filter toxins, affecting brain function)
• People with a significant fluid build-up around the heart, or fluid around the lungs or in the abdomen that requires draining
• People who have had a bleeding event in the 6 months before joining, such as bleeding from varicose veins in the oesophagus or stomach; people who needed a procedure for these varicose veins in the 28 days before joining; or people with untreated or insufficiently treated varicose veins that doctors consider a high bleeding risk
• People who are unable to have contrast-enhanced CT or MRI scans of the liver
• People whose surgery did not meet the criteria for a full, complete removal of the cancer
• People who have taken certain Chinese herbal medicines, traditional patent medicines with anti-tumour properties, or immune-modulating drugs (such as thymosin or interferon) in the 14 days before joining
• People who have taken part in another drug clinical trial in the 4 weeks before joining
• People who have both Hepatitis B and Hepatitis C infections at the same time
• People who have had a serious blood clot or blockage in an artery or vein in the 6 months before joining, including heart attack, unstable chest pain, stroke, mini-stroke, pulmonary embolism, or deep vein thrombosis
• People with significant heart or lung problems
• People with a serious active infection, or who were hospitalised for a severe infection, blood infection, or serious pneumonia in the 4 weeks before their first treatment
• People with a known allergy to any ingredient in the trial drug, or who have had a severe allergic reaction to other traditional Chinese patent medicines
• People with a known history of drug abuse, heavy alcohol use, or substance misuse
• People with a history of a psychiatric condition that affects their ability to understand and consent to participation
• People with other serious health conditions, mental health disorders, or abnormal test results that, in the treating doctor's judgement, could put them at greater risk or affect the reliability of the trial results

Important: Always verify eligibility with the trial site directly before applying.