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:

• Adults aged 18 or older at the time of joining the study.
• People who have signed a written consent form agreeing to take part.
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) or bile duct cancer originating in the liver (intrahepatic cholangiocarcinoma) that cannot be removed by surgery or has spread to other parts of the body, confirmed by tissue or cell testing.
• People whose cancer has continued to grow or spread after receiving a type of immunotherapy treatment that targets the PD-1 or PD-L1 pathway.
• People who have at least one area of cancer that can be measured on a CT scan or MRI using standard imaging criteria (RECIST 1.1).
• People whose general health and ability to carry out daily activities meets a certain minimum level, as rated on a standard medical scale (ECOG performance status of 2 or below).
• People with a life expectancy of at least 12 weeks.
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirm specific values with the trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the trial.
• People who are willing and able to follow all trial requirements, including attending scheduled visits, completing treatment, and using required contraception.

Who may not be able to join:

• People with a history of significant heart disease, or who have had a clinically significant gastrointestinal bleed within 4 weeks before starting the trial.
• People who have had a stroke, mini-stroke (TIA), blood clot in a deep vein, or a blood clot in the lungs within the 6 months before starting treatment (with a limited exception for certain portal vein clots — confirm with trial site).
• People who have previously been treated with Lenvatinib or similar targeted cancer therapies.
• People who have had tumour ablation (RFA) or surgical removal of a tumour less than 4 weeks before the planned start of treatment.
• People who have received radiotherapy less than 4 weeks before the planned start of treatment.
• People who have had major surgery within 4 weeks before starting treatment, or who have not fully recovered from major surgery.
• People who have or have had a second separate cancer, except for certain well-treated skin cancers or very early-stage cervical changes (confirm with trial site).
• People who have a weakened immune system, including those known to be HIV-positive.
• People who have taken part in another clinical trial using an experimental treatment within the last 30 days before joining (or longer, depending on the previous trial medication — confirm with trial site).
• People with any other health condition that, in the treating doctor's judgment, would interfere with the trial, including: a history of scarring lung disease (interstitial lung disease); known acute or long-term inflammation of the pancreas; active tuberculosis; any active infection requiring treatment; a history of receiving a transplanted organ or tissue; a diagnosis of immune deficiency, or use of steroid or immune-suppressing medication within 7 days before starting treatment.
• People with an active autoimmune disease (where the immune system attacks the body) requiring treatment within the past 3 months, or a history of severe autoimmune disease requiring steroids or immune-suppressing drugs — though certain conditions such as vitiligo, thyroid conditions stable on medication, Type 1 diabetes, or mild skin or breathing conditions may be exceptions (confirm with trial site).
• People who have received a live vaccine within 30 days before starting treatment or during the trial.
• People with cancer that has spread to the brain or spinal cord, unless they have completed local treatment, have no symptoms, and have not needed steroids for at least 6 weeks before starting treatment (confirm with trial site).
• People taking medications known to interact with the drugs used in this trial.
• People currently receiving any other active cancer treatment not specified in the trial protocol.
• People who have received any other experimental treatment within 28 days of joining the study.
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not using an effective method of contraception (methods considered acceptable include implants, injectable contraceptives, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence, or a partner's vasectomy).
• People with a significant history of not following medical instructions, or who are unable to provide reliable informed consent.

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