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 (inclusive), of any gender, who are willing to take part and have signed a consent form.
• People who have been diagnosed with advanced or inoperable liver cancer (hepatocellular carcinoma, or HCC), confirmed either by tissue biopsy or by clinical guidelines set by China's National Health Commission.
• People whose liver cancer has continued to grow or spread after at least one previous systemic (whole-body) treatment.
• People whose tumor tissue has tested positive for a protein called FGF19, as confirmed by the central laboratory.
• People with a liver function score (Child-Pugh) of A or B, with a score of 7 or lower.
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C (confirm with trial site if unsure of staging).
• People with a general health performance score (ECOG) of 0 or 1, meaning they are fully active or able to carry out light activity.
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1).
• People with a life expectancy of at least 12 weeks.
• People with adequate blood counts and organ function (such as kidney and liver function) as determined by the trial site.
• People with a hepatitis C (HCV) infection where the virus is detectable in blood, provided antiviral treatment has been started before the first dose of the trial drug.
• People with a hepatitis B (HBV) infection, provided the amount of hepatitis B virus in their blood is below a specified level (less than 10,000 copies/mL or 2,000 IU/mL).
• People (and partners of male participants) who are willing to use effective contraception from the screening period until 6 months after the last dose of the trial drug.

Who may not be able to join:

• People who have taken part in another clinical drug or device trial within the 28 days before the first dose.
• People who have received any anticancer treatment — including chemotherapy, radiation therapy, targeted therapy, immunotherapy, or hormone therapy — within 4 weeks before the first dose (or within five half-lives of that drug, whichever is shorter); or traditional Chinese medicine with anticancer indications within one week before the first dose. Note: palliative radiotherapy completed at least two weeks beforehand may be allowed (confirm with trial site).
• People who still have side effects from previous cancer treatment that have not returned to a mild level (grade 1 or lower) or back to their baseline health status.
• People who have previously received any FGFR inhibitor medication, including FGFR4 inhibitors or broader pan-FGFR inhibitors.
• People who have had major surgery (other than a biopsy) within 4 weeks before the first dose, or whose surgical wound has not fully healed.
• People with moderate to large build-up of fluid around the lungs or in the abdomen that is causing symptoms, is not controlled, or requires repeated draining.
• People with an active autoimmune disease, or a history of one that is likely to return (such as lupus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid conditions, multiple sclerosis, vasculitis, or glomerulonephritis), or people at high risk due to a previous organ transplant requiring ongoing immune-suppressing medication.
• People who have been diagnosed with another cancer in the 5 years before enrolling in this trial.
• People with cancer that has spread to the membranes around the brain and spinal cord (leptomeningeal metastases), or with active brain metastases.
• People with known active tuberculosis, suspected active tuberculosis, or active pneumonia requiring treatment.
• People with a clinically significant history of heart or stroke-related conditions (confirm with trial site for specific conditions).
• People who have been taking corticosteroids or other immune-suppressing medications systemically within 14 days before the first dose.
• People with a known HIV infection, or an active infection that has required systemic treatment for more than 7 consecutive days within the 14 days before the first dose.
• People who have both hepatitis B and hepatitis C infections at the same time.
• People who have received a blood transfusion, or certain blood-boosting medications (such as G-CSF, GM-CSF, thrombopoietin, or erythropoietin) within 2 weeks before the first dose.
• People who are taking bile acid-modifying medications that cannot be stopped at least 3 days before the first dose (or within 5 half-lives of that medication, whichever is longer).
• People with a history of severe allergic reactions to therapeutic antibody drugs, known allergies to multiple substances, or severe allergic disease.
• People who are pregnant, breastfeeding, or who have a positive blood pregnancy test.
• People with other serious medical or psychiatric conditions, or significant abnormal test results, that the trial investigator believes could put them at risk or affect the trial results.

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