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 test positive for hepatitis B surface antigen (HBsAg) with levels at or above a certain threshold in their blood
• People who are 18 years of age or older at the time of signing consent
• People who are able to understand and follow the study requirements, and who have signed a consent form
• People who have a confirmed diagnosis of liver cancer (hepatocellular carcinoma, or HCC) based on tissue or cell testing done within the past year
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B — where local treatments are not an option — or stage C (confirm with trial site)
• People whose liver function falls within a scoring range called Child-Pugh class A or B
• People whose general physical ability and activity level is rated 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity)
• People who were already being treated with one of three specific antiviral medications — entecavir, tenofovir, or TAF — before starting the cancer treatments used in this trial
• People who have at least one tumour that has not been treated with radiation, measures 10 mm or more in its longest dimension (or, for lymph nodes, 15 mm or more across the short side), and can be measured consistently using CT or MRI scans
• People whose blood counts and organ function meet all of the following levels (not achieved through recent transfusions, infusions, or growth factor support in the 14 days before treatment starts, for some of these):
  • Haemoglobin at or above 9 g/dL
  • Neutrophil count at or above 1,000 per microlitre
  • Platelet count at or above 75,000 per microlitre
  • Total bilirubin no higher than twice the normal upper limit
  • Liver enzymes (AST and ALT) no higher than five times the normal upper limit
  • Albumin at or above 2.8 g/dL
  • INR (a blood clotting measure) at or below 1.6
  • Kidney function (creatinine clearance) at or above 50 mL per minute

Who may not be able to join:

• People whose liver cancer is a specific rare type called fibrolamellar carcinoma, or a mixed type involving both liver and bile duct cells
• People who have had radiation therapy within the past 4 weeks (or 2 weeks for radiation to bone), or a radioactive treatment (such as I-131 or Y-90) within the past 6 weeks, or who have ongoing complications from prior radiation
• People who have previously been treated with interferon
• People currently taking blood thinners or anti-clotting medications at full therapeutic doses — such as warfarin, low molecular weight heparin, thrombin inhibitors, factor Xa inhibitors, or antiplatelet drugs like clopidogrel (note: low-dose aspirin for heart protection, very low-dose warfarin of 1 mg/day or less, and low-dose heparin are permitted)
• People with serious or uncontrolled ongoing illnesses, including:
  • Heart conditions such as heart failure with symptoms, unstable chest pain, or serious irregular heartbeat
  • High blood pressure that remains above 150/100 mmHg despite treatment
  • A stroke, mini-stroke (TIA), heart attack, or other reduced blood flow event in the past 6 months
  • A blood clot event (other than clots in liver-related blood vessels caused by liver disease or tumour) within the past 3 months
  • Stomach or bowel conditions that carry a high risk of perforation or abnormal openings, such as tumours growing into the digestive tract, active peptic ulcers, inflammatory bowel disease, or acute pancreatitis
  • An abdominal fistula, bowel perforation, bowel obstruction, or abdominal abscess within the past 6 months
  • Major surgery within the past 2 months, or minor surgery within the past 7 days, without full healing
  • Certain lung conditions, including cavities in lung tissue or disease blocking the airways
  • A tumour that is growing into a major blood vessel such as the aorta or pulmonary artery
  • Significant bleeding risk, including blood in urine or vomit, coughing up more than 2.5 mL of blood, or other signs of serious bleeding within the past 3 months
  • HIV infection or AIDS requiring systemic treatment
  • Serious non-healing wounds, ulcers, or bone fractures
  • A condition that severely affects the body's ability to absorb nutrients
  • Underactive thyroid (hypothyroidism) that is uncontrolled or causing symptoms
  • Dependence on kidney dialysis (haemodialysis or peritoneal dialysis)
• People with untreated or incompletely treated swollen veins in the oesophagus (varices) that are bleeding or at high risk of bleeding — people with a past history of variceal bleeding may be considered if they have had adequate treatment, no recurrence for at least 6 months, and are stable on appropriate medications (confirm with trial site)
• People with moderate or severe fluid build-up in the abdomen (ascites)
• People with a heart electrical interval measurement (QTcF) above 500 ms on an ECG taken within 7 days before starting treatment (confirm with trial site for how multiple readings are assessed)
• People who are unable to swallow tablets
• People with a known allergy or sensitivity to any ingredient in the study treatments
• People who are pregnant or currently breastfeeding
• People who have been diagnosed with another cancer within the past 2 years, except for certain minor skin cancers or low-grade localised tumours considered cured without systemic treatment

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