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 or older at the time of signing the consent form
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer), confirmed either by a tissue sample or by standard clinical criteria in people with liver scarring (cirrhosis)
• People who have at least one measurable liver cancer lesion that has not yet been treated, or whose previously treated lesion has since grown or spread according to standard measurement guidelines
• People whose cancer is locally advanced, has spread to other parts of the body, or cannot be surgically removed
• People who have not yet received any systemic (whole-body) treatment for advanced liver cancer
• People whose liver function falls into Child-Pugh Class A (a measure of how well the liver is working)
• People whose cancer is classified as BCLC Stage B (where local treatment to the liver is not suitable) or Stage C
• People with an ECOG performance score of 0 or 1 (meaning they are fully active or have only minor limitations in physical activity)
• People whose recent blood test results meet specific thresholds for blood cell counts, liver function, kidney function, and clotting, as assessed within 28 days before joining
• Women who could become pregnant must have a negative pregnancy test at screening and must be willing to use highly effective contraception during the study and for 6 months after the last dose of study treatment
• Men whose partner could become pregnant must be surgically sterile or willing to use highly effective contraception during the study and for 6 months after the last dose
• Women must agree not to donate or retrieve eggs from screening through to at least 6 months after the final dose
• Men must agree not to freeze or donate sperm from screening through to at least 6 months after the final dose
• People willing to return to the enrolling institution for follow-up visits during active treatment
• People willing to provide blood samples for research purposes
• People who have side effects from previous cancer treatments that have resolved to a mild level, with some exceptions allowed for stable, long-standing mild-to-moderate side effects such as nerve-related symptoms, fatigue, or certain hormone-related conditions from prior immunotherapy (confirm with trial site)

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who are not willing to use adequate contraception when required
• People who have received a liver-directed treatment (such as TACE, Y-90, or liver-directed radiation) within 28 days before joining
• People with serious other illnesses or conditions that, in the doctor's opinion, would make participation unsafe or affect how the study results are assessed
• People with significant or uncontrolled heart conditions, including abnormal heart rhythms, a heart attack within the past 6 months, uncontrolled chest pain within the past 6 months, severe heart failure, or blood pressure that remains too high despite treatment
• People who have had another active cancer in the past 3 years, except for certain easily cured skin cancers, superficial bladder cancer, cervical changes that have not become cancer, or a chance finding of very early prostate cancer
• People who have previously been treated with a type of medication called an EZH inhibitor
• People currently taking certain medications that strongly affect how the body processes drugs (specific CYP3A inducers or strong CYP3A/P-gp inhibitors), particularly during the dose-finding phase of the trial (confirm with trial site)
• People with a weakened immune system, or people known to be HIV-positive and currently receiving HIV treatment, or people with AIDS
• People with hepatitis B whose virus levels in the blood are too high, or who are not on appropriate antiviral treatment as required by the trial's specific hepatitis B criteria (confirm with trial site)
• People with active hepatitis C (where the virus is currently detectable in the blood)
• People with an ongoing serious infection (bacterial, fungal, or viral) requiring intravenous treatment — though minor skin or nail fungal infections are generally acceptable
• People with a medical history, physical condition, or mental health condition that the doctor believes makes participation unsafe or unsuitable
• People whose personal, social, family, geographic circumstances, or substance use would prevent them from attending regular follow-up visits
• People who have coughed up a significant amount of bright red blood in the month before starting treatment
• People with a known tendency to bleed abnormally or a significant clotting disorder (when not on blood thinners for treatment purposes)
• People currently or recently (within 10 days of the first dose) using high-dose aspirin or certain blood-thinning medications such as clopidogrel or dipyridamole
• People currently or recently (within 10 days of the first dose) using full-dose blood thinners or clot-dissolving treatments for treatment purposes — though certain low-dose preventive uses may be allowed (confirm with trial site)
• People who have had a core biopsy or minor surgical procedure (other than insertion of a vascular access device) within 3 days before the first dose of bevacizumab (one of the study drugs)
• People with a history of certain serious abdominal events — such as a fistula, bowel perforation, or abdominal abscess — within the past 6 months
• People with a history of bowel obstruction or related symptoms within the past 6 months, unless surgically resolved
• People with unexplained free air in the abdomen
• People with a serious non-healing wound, active ulcer, or untreated bone fracture
• People whose cancer involves major airways or large blood vessels, or has large tumour masses near the central airways — though cancer involving certain liver blood vessels may be acceptable (confirm with trial site)
• People with a history of inflammatory conditions in the abdomen (such as peptic ulcers, diverticulitis, or colitis) within the past 6 months
• People who have had radiotherapy within 28 days before starting treatment, or abdominal/pelvic radiotherapy within 60 days — with some exceptions for palliative bone treatment
• People who have had major surgery, an open biopsy, or significant injury within 28 days before starting treatment, or abdominal surgery or injury within 60 days, or who are expected to need major surgery during the study
• People who take anti-inflammatory medications (NSAIDs) daily on an ongoing basis — occasional use for things like headaches or fever is generally acceptable
• People diagnosed with specific rare subtypes of liver cancer, including fibrolamellar carcinoma, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma
• People with untreated or inadequately treated varicose veins in the oesophagus that are bleeding or at high risk of bleeding — an endoscopy assessment and treatment must be completed before joining (within 6 months prior, if already done)
• People who have received an organ transplant from another person
• People with active or previously documented autoimmune or inflammatory conditions (such as inflammatory bowel disease, lupus, rheumatoid arthritis, and others) — some exceptions apply, including vitiligo, stable thyroid conditions on medication, and certain diet-controlled conditions (confirm with trial site)
• People with a history of cancer spread to the lining of the brain or fluid around the brain, or to the brain itself
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have used immunosuppressive medications within 14 days before joining — some exceptions apply, such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions to scans (confirm with trial site)
• People who have received a live vaccine within 30 days before joining — and live vaccines should not be given during treatment or within 30 days after the last dose

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