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 who have been diagnosed with advanced liver cancer (hepatocellular carcinoma) confirmed by a pathology test.
• People whose cancer has continued to grow or spread after receiving prior treatment that included immunotherapy (immune checkpoint inhibitors), confirmed by medical imaging.
• People whose liver cancer is classified as a certain stage (BCLC stage B or C) and who are not able to have, or have chosen not to have, surgery or local liver treatments such as arterial procedures or ablation.
• People whose liver is functioning at a certain level (Child-Pugh class A or B, with a score of 7 or lower), with no history of a condition called hepatic encephalopathy (brain problems caused by liver disease).
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard medical fitness scale (ECOG score).
• People who have at least one measurable tumour outside the brain, as assessed by standard imaging criteria.
• People whose life expectancy is estimated to be at least 3 months.
• People who have tumour tissue samples available (including stored samples) that have been tested and show high levels of a protein called AKR1C3.
• People whose kidneys, liver, blood, and other organs are functioning well enough to meet the trial's requirements.
• People with hepatitis B who have a low level of the virus in their blood and are already receiving hepatitis B treatment, which must continue throughout the trial and for 6 months after the last dose.
• People with hepatitis C whose virus levels are undetectable by the trial centre's testing methods.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding.
• Both men and women who could have children must agree to use effective contraception from the time of joining the trial until 6 months after the last dose.
• People who are willing to take part voluntarily, sign a written consent form after being fully informed about the trial, and are able to follow the trial procedures and attend follow-up appointments.

Who may not be able to join:

• People whose liver cancer is a specific less common type, such as intrahepatic cholangiocarcinoma, dual-phenotype hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, or carcinosarcoma.
• People who have untreated cancer that has spread to the brain or spinal cord (central nervous system). People with previously treated and stable brain metastases that have been stable for at least 4 weeks, require no steroids or anti-seizure medication, and cause no symptoms may still be considered (confirm with trial site).
• People who have had another type of cancer within the past 2 years, with some exceptions for certain early-stage or skin cancers that have been fully treated and are unlikely to interfere with this trial.
• People with a history of serious heart or stroke-related conditions.
• People who have received cancer treatments — including radiation, chemotherapy, immunotherapy, or targeted therapy — within 4 weeks (or within a shorter window depending on the specific drug) before the first trial dose.
• People who have had major surgery within 4 weeks before the first trial dose (not including minor diagnostic procedures or local liver treatments).
• People who have taken part in another clinical trial and received an experimental drug within 4 weeks before the first trial dose.
• People who still have side effects from previous cancer treatments that have not mostly resolved before starting the trial.
• People who have a moderate to large build-up of fluid around the lungs, heart, or abdomen that is causing symptoms or has required drainage within 2 weeks before starting treatment.
• People who need to take certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) during the trial period.
• People who have a serious active infection requiring antibiotic or antiviral treatment at the time of screening.
• People who are known to have HIV, or who test positive for syphilis.
• Women who are pregnant, breastfeeding, or planning to become pregnant.
• People with other health conditions or physical issues that the trial doctor believes would make participation unsafe, including recent serious gastrointestinal bleeding, active stomach ulcers, or uncontrolled mental health conditions.
• People with a known allergy or sensitivity to ethanol (alcohol) or propylene glycol (a common ingredient in some medicines).
• People whom the trial doctor considers unsuitable for any other reason.

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