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:

• The patient (or their legal guardian, for those under 18) must be willing and able to give written consent to participate, and must be able to understand the study and its risks — including patients with a history of major psychiatric illness, as assessed by the trial team.
• The patient must have a confirmed diagnosis of fibrolamellar hepatocellular carcinoma (FLHCC), either through a new tissue sample or documented records from an original biopsy.
• The patient must have at least one tumour that can be measured — generally at least 15 mm using standard imaging, or at least 10 mm using more detailed scans such as MRI or spiral CT.
• The patient must be in reasonably good general health, as measured by standard medical scoring tools (ECOG score of 0 or 1 for adults, or Karnofsky score of 70 or higher for those under 18).
• The patient must have no advanced liver scarring (cirrhosis), specifically rated as Child-Pugh A liver function.
• Blood test results taken within 14 days before the first dose must show the immune cell count (neutrophils) is at an acceptable level (at least 1,000 per mm³).
• Blood test results must show platelet count is at an acceptable level (at least 100,000 per mm³) within 14 days before the first dose.
• Blood test results must show haemoglobin is above 9.0 g/dL within 14 days before the first dose (blood transfusions or supportive medication may be used to reach this level).
• Blood test results must show bilirubin (a liver marker) is at an acceptable level (no more than 1.5 mg/dL) within 14 days before the first dose.
• Blood test results must show kidney function is within an acceptable range within 14 days before the first dose (confirm specific values with trial site).
• Blood test results must show liver enzyme levels (AST and ALT) are no more than five times the upper limit of the normal range within 14 days before the first dose.
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting the study drug.
• Women who could become pregnant must agree to use reliable contraception during treatment and for 5 months after treatment ends.
• Men who are sexually active with women who could become pregnant must agree to use reliable contraception during treatment and for 7 months after treatment ends.
• Women who could become pregnant must continue pregnancy testing during the study, even if they are not sexually active with men.

Who may not be able to join:

• People who have had another cancer within the past 2 years, with the exception of certain non-melanoma skin cancers or early-stage (in situ) cancers.
• People who have received an organ transplant from a donor.
• People who have had major surgery, an open biopsy, or a serious injury with a poorly healed wound within the 6 weeks before the first dose, or who are expected to need major surgery during the study.
• People with a history of autoimmune conditions such as inflammatory bowel disease (including Crohn's disease or ulcerative colitis), rheumatoid arthritis, lupus, scleroderma, or autoimmune blood vessel inflammation.
• People who have tested positive for HIV or have AIDS.
• People with an underlying health condition that, in the trial doctor's judgement, would make the study drug unsafe or make it difficult to assess side effects — for example, a condition causing frequent diarrhoea.
• People with a history of serious bowel problems such as acute diverticulitis, bowel perforation, an abdominal abscess, an abdominal fistula, bowel obstruction, or cancer spread throughout the abdominal cavity.
• People with a primary brain tumour (excluding certain benign types), brain metastases, cancer affecting the lining of the brain or spinal cord, seizures not controlled by standard medication, or a stroke within the past year.
• People with a history of serious heart or blood vessel conditions within the past 12 months — including heart attack, unstable chest pain, hypertensive crisis, poorly controlled high blood pressure, significant heart failure, or serious irregular heartbeat requiring medication (note: stable atrial fibrillation may still be eligible — confirm with trial site).
• People with any other medical condition, abnormal test result, or physical finding that the trial team considers would make participation unsafe or affect the study results.
• People who have received a live or weakened live vaccine within one month before starting the study drug.
• People with an active hepatitis B infection (confirmed by specific blood tests at screening).
• People with an active hepatitis C infection (confirmed by specific blood tests at screening).
• People with a history of blood clotting disorders, abnormal bleeding, or thrombosis (blood clots) within the past year.
• People with a serious wound, ulcer, or bone fracture that has not healed.
• People who are pregnant or breastfeeding.
• People who have previously had a liver transplant.
• People with cirrhosis and seriously impaired liver function (rated Child-Pugh B or C).
• People who have previously been treated with anti-PD-1 immunotherapy for FLHCC, or who are currently receiving any other systemic cancer treatment for FLHCC.
• People who are currently enrolled in, or scheduled to receive, another experimental treatment.
• People who require ongoing blood-thinning medication (anticoagulants), other than low-dose aspirin (note: short-term preventive anticoagulation around surgery is permitted).
• People who require nutrition delivered directly into a vein (total parenteral nutrition).
• People currently taking high-dose steroids (for example, more than 10 mg of prednisone daily) or strong immune-suppressing medications such as infliximab.
• People who would not be able to attend the required appointments throughout the study.

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