Phase 2 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:

• People who have liver cancer (hepatocellular carcinoma) that cannot be removed by surgery.
• People who have not yet received any systemic (whole-body) treatment for their unresectable liver cancer.
• People aged 18 or older who are in reasonably good general health and able to carry out daily activities with little or no limitation (as measured by a standard doctor's assessment scale).
• People who have recovered from side effects of any previous treatments, with only mild or stable issues remaining.
• People whose blood test results show that their organs (such as kidneys, liver, and bone marrow) are functioning well enough, tested within 14 days before starting the study.
• People whose kidney protein levels fall within the acceptable range set by the trial.
• People who are able to provide a fresh tumour tissue sample (biopsy) at the start of the trial, or who have a stored tumour tissue sample that meets the trial's requirements.
• People who are able to understand the study requirements and have signed a consent form agreeing to take part.
• People who are sexually active and able to have children must agree to use highly effective contraception before, during, and for a set period after treatment, plus an additional barrier method (such as a condom). Men must also agree not to donate sperm, and women must agree not to donate eggs, during this period.
• Women who could potentially become pregnant must have a negative pregnancy test at the start of the study.

Who may not be able to join:

• People who have previously been treated with the study drugs XL092, or any PD-1, PD-L1, or CTLA-4 inhibitor medications.
• People who have taken certain targeted cancer medicines (such as cabozantinib or similar drugs that block specific cancer-related proteins) within 2 weeks before the first dose.
• People who have received any other type of systemic cancer treatment within 4 weeks before the first dose.
• People who have had radiation therapy to bones within 2 weeks, or any other radiation therapy within 4 weeks, before the first dose; or who have received radioactive treatment through the bloodstream within 6 weeks before the first dose, or who have ongoing significant complications from past radiation.
• People who have cancer that has spread to the brain or the area around the brain, unless it has been successfully treated and has been stable for at least 4 weeks (confirm with trial site for specific exceptions).
• People who are currently taking blood-thinning medicines such as warfarin or clopidogrel (certain limited blood thinners may be permitted — confirm with trial site).
• People who have used herbal supplements or traditional medicines to treat their cancer within 2 weeks before the first dose.
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, dangerous heart rhythm problems, uncontrolled high blood pressure, or who have had a stroke or heart attack within the past 12 months.
• People who have had a serious blood clot in the lungs or a significant blood clot in a vein within the past 6 months (some exceptions may apply — confirm with trial site).
• People with a history of heart muscle inflammation (myocarditis).
• People with serious stomach or bowel problems, including active ulcers, inflammatory bowel disease, bowel blockage, a hole in the bowel, or known varicose veins in the stomach or oesophagus.
• People who have had significant bleeding (such as coughing or vomiting blood) within 12 weeks before the first dose.
• People who have certain types of lung lesions or disease affecting the airways.
• People whose cancer is growing into major blood vessels such as the main vein to the heart, the main lung artery, or the aorta (some exceptions may apply — confirm with trial site).
• People with an active infection that requires treatment with medicines taken throughout the body.
• People with a known active or chronic hepatitis B or C infection, or HIV/AIDS.
• People who have had a confirmed or suspected COVID-19 infection within one month before enrolling, unless full recovery can be demonstrated.
• People with a serious wound, ulcer, or bone fracture that is not healing properly.
• People who have a condition that prevents their body from properly absorbing medicines taken by mouth.
• People with an underactive thyroid gland that is not being adequately managed with medication and is causing symptoms.
• People with moderate to severe liver disease (Child-Pugh class B or C, or a Child-Pugh score above 7).
• People who require kidney dialysis.
• People who have previously received a solid organ transplant or a stem cell transplant from a donor.
• People who have had major surgery within 8 weeks before the first dose, or minor surgery within 10 days before the first dose, or who have not fully healed from any surgery.
• People whose heart's electrical activity (measured by an ECG) shows a reading outside the acceptable range set by the trial, tested within 14 days before the first dose.
• People with a history of a psychiatric condition that could make it difficult to follow the study requirements or give informed consent.
• People who are pregnant or breastfeeding.
• People who are unable to swallow tablets.
• People who have a known allergy or sensitivity to any ingredient in the study medicines.
• People who have had another cancer diagnosed within the past 2 years, with some exceptions for certain low-risk or superficial skin cancers, and early-stage low-grade prostate cancer (confirm with trial site).
• People with any other condition that the study doctor believes would make participation unsafe or make it difficult to complete the study.
• People with an active autoimmune disease that requires long-term treatment with medicines that suppress the immune system (some limited conditions are permitted — confirm with trial site).
• People with a confirmed tuberculosis infection that is supported by medical evidence of active disease.
• People with a history of certain lung scarring or inflammation conditions, or who show signs of active lung inflammation on a CT scan at the start of the study.
• People whose thyroid hormone level (FT4) falls outside the normal range, unless approved by the lead investigator after review.
• People with an immune deficiency condition, or who are currently taking high-dose steroid medicines or other immune-suppressing treatments within 2 weeks before the first dose (some exceptions apply — confirm with trial site).
• People who have received a live vaccine within 30 days before the first dose.
• People who have had a documented episode of confusion or brain problems caused by liver disease (hepatic encephalopathy) within the past 6 months.
• People who have had clinically significant fluid build-up in the abdomen (ascites) requiring drainage or increased water tablet treatment within the past 6 months.
• People who have received any local liver cancer treatments — such as surgery, ablation, chemoembolisation, or radioembolisation — within 28 days before the first dose.

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