Phase 3 Liver Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older, of any gender
• People diagnosed with a type of primary liver cancer called hepatocellular carcinoma (HCC), confirmed either through medical imaging according to Chinese clinical guidelines or through a tissue/cell sample test
• People whose liver cancer cannot be removed by surgery
• People whose blood test results show a combined score of 2 or more points based on three specific markers: a protein called AFP being high, a immune marker called TNF-α being low, and another immune marker called IFN-γ being high (confirm with trial site for exact score calculation)
• People who have not previously received any first-line (standard) systemic drug treatments for HCC, including targeted therapies, immunotherapy, or chemotherapy drugs such as sorafenib, lenvatinib, atezolizumab, and others listed in the criteria
• People with a liver function score (Child-Pugh score) of 7 or below
• People whose blood counts, liver function, and kidney function test results fall within the ranges specified by the trial
• People with hepatitis B whose virus levels are being managed with antiviral treatment down to an acceptable level before joining
• People who are either not considered suitable candidates for standard first-line treatments, or who do not wish to receive standard first-line treatments
• People who finished surgery more than 3 months ago, or finished local treatments such as ablation, radiation, or liver artery procedures more than 4 weeks ago, with side effects resolved; people without cancer spread outside the liver must have imaging showing the cancer has progressed after local treatment
• People who previously received adjuvant (preventive) systemic therapy after surgery and whose cancer first showed progression on imaging more than 6 months after stopping that therapy
• People who have not used certain traditional Chinese medicine anti-cancer preparations, immune-modifying drugs, cancer vaccines, or cell-based immune therapies in the 2 weeks before joining
• People who have not received blood transfusions, blood products, certain blood-boosting injections, or albumin infusions in the 2 weeks before joining
• People who have at least one measurable tumour lesion visible on medical imaging, meeting specific size requirements set out in the trial criteria
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or restricted only in strenuous activity)
• People expected to live at least 12 weeks
• Women of childbearing age who have a negative blood pregnancy test within 7 days before joining; all participants of childbearing potential (or with partners of childbearing potential) must use effective contraception during treatment and for 3 months after the last dose
• People who are willing and able to sign an informed consent form and follow the trial schedule
• People who have not taken part in any other clinical trial involving experimental drugs or devices in the 4 weeks before joining

Who may not be able to join:

• People whose tumour takes up 70% or more of the liver, or where a blood clot caused by the tumour blocks 50% or more of the main portal vein, or where the tumour has spread into certain major abdominal veins
• People with moderate to severe fluid build-up in the abdomen, or moderate to severe or symptomatic fluid around the lungs or heart that requires draining
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 28 days before joining, or who are expected to need major surgery during the trial
• People with other types of liver cancer (such as cholangiocarcinoma or mixed types), or people who have had another cancer within the past 5 years (with exceptions for certain fully treated skin cancers or carcinoma in situ)
• People who are pregnant or breastfeeding
• People with significant heart problems, including moderate to severe reduced blood flow to the heart, heart attack, poorly controlled irregular heartbeat, or moderate to severe heart failure
• People who have previously had an organ transplant including a liver transplant, or who plan to have a liver transplant during the trial
• People who have had episodes of brain confusion caused by liver failure (hepatic encephalopathy) or kidney problems caused by liver disease (hepatic nephropathy) in the 6 months before joining
• People who test positive for hepatitis C virus (HCV-RNA) and also have elevated liver enzyme levels
• People who test positive for HIV
• People with a severe active infection at the time of joining
• People who are unable to swallow, or who have ongoing severe diarrhoea or bowel blockage that would prevent them from taking the study drug properly
• People who have had gastrointestinal bleeding in the 6 months before joining, or who currently show signs suggesting a risk of gastrointestinal bleeding
• People with active autoimmune diseases that require ongoing systemic treatment (exceptions may apply for people on simple hormone replacement therapies such as thyroid hormone or insulin)
• People with known cancer spread to the brain or central nervous system; people suspected of having this will need brain imaging to rule it out
• People with significant abnormalities in blood clotting test results
• People with a history of schizophrenia or misuse of psychiatric medications
• People with a known allergy or intolerance to any ingredients in the study drugs (icaritin or huachansu preparations)
• People whom the trial investigators consider unsuitable for any other reason

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