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 given written consent to take part in the study
• People whose primary diagnosis is liver cancer (HCC), who are planned to receive radiation treatment, have not yet received any systemic (whole-body) drug treatment for liver cancer, and may have previously had a procedure called TACE
• People whose liver cancer has been confirmed either by tissue biopsy or by specific imaging results meeting a standard called LI-RADS 5
• People who have a general health and activity level rated 0 to 2 on a standard scale used by doctors (meaning they are able to carry out at least some daily activities, even if limited)
• People aged 18 years or older
• People whose liver is functioning at a level doctors classify as Child-Pugh A or B7, and whose cancer stage is classified as BCLC A, B, or C, or who have been assessed as not being suitable for surgery or a liver transplant
• People whose cancer has not spread outside the liver, as confirmed by CT or MRI scans of the chest, abdomen, and pelvis
• Women who could become pregnant must be willing to use a highly effective form of contraception for the full duration of the study and for at least 6 months after the last dose of the study drug, and must have a negative pregnancy test within 7 days before starting treatment
• Men who are not sterile must be willing to use a highly effective form of contraception for the full duration of the study and for at least 6 months after the last dose of the study drug, and must agree not to donate or bank sperm during treatment and for more than 6 months after stopping treatment
• People who have at least one tumour that can be measured in one direction using standard imaging guidelines (RECIST 1.1)
• People whose blood counts, kidney function, liver function, and blood clotting results fall within the ranges required by the study (confirm specific values with trial site)
• People with autoimmune underactive thyroid (hypothyroidism) who are on a stable dose of thyroid hormone replacement
• People with well-controlled Type 1 diabetes on a stable insulin regimen
• People with certain stable, mild skin conditions (such as eczema, psoriasis, or vitiligo) affecting less than 10% of the body surface and managed only with low-strength topical steroids

Who may not be able to join:

• People who have previously had radiation therapy to the liver area that could cause unsafe overlap with new radiation fields
• People who have ever received a type of internal radiation therapy using Yttrium (also called SIRT or hepatic arterial Yttrium therapy)
• People with severe, active other serious health conditions, as assessed by the treating doctor
• People who have more than five separate areas of confirmed liver cancer within the liver, or who have a blood clot in the main or branch portal vein
• People whose tumour has grown directly into the stomach, small bowel, or large bowel
• People whose liver cancer involves a main bile duct in a way that is measurable on imaging
• People whose cancer has spread outside the liver in a way that measures more than 3.0 cm in total across all affected sites (for example, one lymph node measuring 3.4 cm, or two lung spots each measuring 2 cm)
• People who have previously had a liver transplant
• People who are HIV positive
• People with an immune system condition that requires ongoing systemic treatment or that may return
• People who have previously received immunotherapy treatment
• People with fluid build-up in the abdomen (ascites) that has required a draining procedure (paracentesis) to manage symptoms (note: people whose ascites is managed with diuretic medications at a stable dose for at least two months before starting treatment may still be eligible — confirm with trial site)
• People with significant confusion or brain function changes related to liver disease (hepatic encephalopathy)
• People who have had a previous transplant of a solid organ or bone marrow, except for people with a prior kidney transplant where dialysis could be used if the transplant fails
• People whose hepatitis B virus (HBV) level in the blood is 500 IU/mL or higher within 28 days before starting the study drug, or who have not been on virus-suppressing treatment for at least 14 days before starting
• People who have both hepatitis B and hepatitis C infections at the same time
• People with another cancer diagnosed within the past 5 years, other than the liver cancer being studied or certain locally treated cancers that have been fully cured (such as some skin cancers or early cervical or breast changes)
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before starting the study drug (note: standard inactivated flu and COVID-19 vaccines are generally permitted; nasal spray vaccines are not)
• People who have needed systemic corticosteroids at a dose greater than 10 mg of prednisone per day (or equivalent), or other immune-suppressing medicines, within 14 days before the first dose (certain lower-dose or short-term steroid uses may still be permitted — confirm with trial site)
• People with uncontrolled diabetes, or significant abnormalities in potassium, sodium, or calcium levels, or severe low albumin levels within 14 days before the first study dose
• People with a history of lung inflammation (interstitial lung disease or non-infectious pneumonitis), or uncontrolled lung conditions such as pulmonary fibrosis or acute lung disease
• People with serious ongoing infections requiring antibiotic, antifungal, or antiviral treatment, including tuberculosis
• People who have had a severe infection within 4 weeks before the first study dose, including those who were hospitalised for an infection, had bacteria in the bloodstream, or had severe pneumonia
• People who have taken antibiotic tablets or received antibiotic infusions for treatment purposes within 2 weeks before the first study dose
• People who have had a major surgical procedure requiring general anaesthesia within 28 days before the first study dose
• People who have had certain heart or blood vessel problems within recent months, including chest pain from the heart, a blood clot in the lungs, a heart attack, significant heart failure, serious irregular heartbeat, or a stroke — within the timeframes specified by the trial (confirm with trial site)
• People who have used any herbal medicine intended to treat cancer within 14 days before the first study dose
• People who still have side effects from previous cancer treatments that have not returned to their normal baseline level
• People with underlying health conditions, or alcohol or drug dependence, that could make the study drug unsafe or make it difficult to assess its effects
• People who are currently taking part in another treatment clinical trial

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