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, of any gender.
• People with a confirmed diagnosis of liver cancer (hepatocellular carcinoma, or HCC), either confirmed by a tissue or cell sample from a laboratory report, or diagnosed by a specialist using recognised clinical guidelines.
• People whose liver cancer is at an advanced stage (BCLC Stage C), or at an intermediate stage (BCLC Stage B) where local treatments to the liver are not suitable or have stopped working, and where a curative treatment approach is not possible.
• People with liver function results falling within a specific acceptable range (Child-Pugh class A, or class B with a score of 7 or less, and no brain complications from liver disease), measured within 7 days before starting the trial treatment.
• People whose liver cancer has progressed, who cannot tolerate, or who have a medical reason to avoid at least one prior systemic (whole-body) cancer treatment for advanced HCC. Prior treatment with cabozantinib or lenvatinib is permitted for certain parts of the study.
• People who have at least one area of cancer that can be measured using CT scan or MRI, following standard measurement guidelines (RECIST 1.1). Areas previously treated with radiation or local therapy may count if they have shown signs of cancer growth since treatment.
• People who are willing and able to provide tumour biopsy samples during the screening phase and during the trial.
• People with a general physical functioning score of 0 or 1 on the ECOG scale (meaning fully active or restricted in strenuous activity but able to do light work), measured within 7 days before starting treatment.
• People whose blood test results meet specific minimum levels for immune cells, platelets, red blood cells, liver function markers, kidney function, protein levels, and blood clotting — all measured within 7 days before starting treatment (confirm specific values with the trial site).
• People who have waited the required amount of time since their last cancer treatment before starting the trial — at least 21 days since the last systemic cancer treatment, at least 14–28 days since radiotherapy (depending on the dose), and at least 28 days since local liver treatments such as surgery or ablation.
• People whose side effects from any previous cancer treatment have reduced to mild or no symptoms (grade 1 or lower), with the exception that moderate hair loss or nerve-related tingling or numbness (grade 2) is acceptable.
• People with a past hepatitis C (HCV) infection who have completed HCV treatment at least one month before starting the trial, with virus levels below detectable limits.
• People with controlled hepatitis B (HBV) infection who meet specific criteria around antiviral therapy duration, virus load levels, and blood marker results (confirm specific details with the trial site).
• People with blood pressure at or below 150/90 mmHg at screening, with no changes to blood pressure medications in the week before starting the trial (with or without blood pressure medication).

Who may not be able to join:

• People whose liver cancer is a specific rare subtype: fibrolamellar HCC, sarcomatoid HCC, or a mixed type involving bile duct cancer (cholangiocarcinoma).
• People currently receiving other cancer treatments or experimental therapies.
• People currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4/5 inhibitors or inducers) and who cannot stop these medications within required timeframes before starting the trial (confirm timeframes with the trial site).
• People with a known history of Gilbert's syndrome or other inherited conditions affecting a specific liver enzyme (UGT1A1).
• People with a known allergic reaction to drugs that are chemically or biologically similar to tegavivint or other drugs used in this trial.
• People who have or have had another active cancer, with some exceptions: skin cancers (basal cell or squamous cell) or cancers in situ (such as early breast or cervical) that have been potentially cured are not excluded; cancers that were treated and have not returned within the past 3 years, or slow-growing cancers that have never needed treatment, are also not excluded.
• People who do not have adequate vein access for drug delivery and blood sample collection, or who have any condition that would interfere with these procedures.
• People whose cancer has spread to the brain or central nervous system.
• People with uncontrolled ongoing or active infections (other than controlled HBV as described above), unhealed wounds or open drainage, or mental health or personal circumstances that would make it difficult to follow the study requirements.
• People with significant or uncontrolled heart conditions, including moderate-to-severe heart failure, reduced heart pumping function (ejection fraction below 50%), unstable chest pain or irregular heartbeat, abnormal heart electrical readings on ECG above a certain threshold, a personal or family history of certain inherited heart rhythm conditions, a heart attack within the past 6 months, or significant fluid around the heart (confirm specific values with the trial site).
• People who have had major surgery within 21 days before starting the trial. Major surgery includes significantly invasive procedures into major body cavities or surgery requiring lengthy recovery (confirm with trial site if unsure whether a procedure qualifies).
• People who are pregnant or breastfeeding, as the trial drug tegavivint may harm an unborn baby or infant.
• People who are capable of becoming pregnant, or male participants who are sexually active with someone capable of becoming pregnant, who are unwilling or unable to use specified contraception methods during the trial and for at least 4 months after finishing treatment.
• People living with HIV who are on combination antiretroviral therapy, due to potential interactions with the trial drug.
• For participants receiving cabozantinib or lenvatinib as part of the trial, additional exclusions apply, including: large, untreated varicose veins in the oesophagus at risk of bleeding; uncontrolled high blood pressure despite treatment; severe levels of protein in the urine; significant bleeding within the past 30 days; blood clots or stroke within the past 6 months; current use of medications known to affect heart rhythm; or a known allergy or intolerance to cabozantinib or lenvatinib (confirm specific arm eligibility with the trial site, as some exceptions may apply).

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