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
• People whose general health and ability to carry out daily activities meets a certain minimum standard (rated 0 or 1 on a medical scale called ECOG — confirm with trial site what this means for a specific situation)
• People who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC), either confirmed by a tissue sample or by specialised liver imaging following established diagnostic guidelines
• People whose liver cancer involves a blood vessel near the liver called the portal vein, in a limited section of it (not the main trunk), as seen on a CT scan or MRI
• People who have at least one liver tumour measuring 10mm or more that can be tracked on imaging scans
• People whose cancer affects less than half of the total liver volume
• People where at least 30% of the liver tissue would remain untreated after the study procedure (a targeted radiation treatment called SIRT)
• People with either no liver scarring (cirrhosis) or a mild, well-compensated form of it, as measured by standard liver health scores (Child-Pugh A, and ALBI score 1 or 2)
• People for whom a specialist medical team has agreed that the SIRT procedure is appropriate, and who are not currently candidates for surgery, heat-based tumour destruction, or a liver transplant
• People who are registered with a social security scheme (this appears to be a French healthcare requirement — confirm with trial site)
• People who have given written informed consent to participate

Who may not be able to join:

• People whose portal vein blockage affects the main trunk of that vessel (partially or completely)
• People whose cancer has spread outside the liver, except for a small lymph node near the liver that is less than 2cm in size
• People who have had a build-up of fluid in the abdomen (ascites) at any point in the past, or who currently have it — even if only detected on a scan with no obvious symptoms (except a very small amount immediately around the liver)
• People who have ever had a brain complication related to liver failure (hepatic encephalopathy), currently have it, or have had a significant episode of it in the 6 months before the study
• People with significant breathing difficulties, including low blood oxygen levels or a chronic lung condition called COPD
• People with a history of lung inflammation caused by radiation, or who have had pneumonitis (lung inflammation) recently, regardless of the cause
• People who have previously received certain treatments for their liver cancer, including: any prior systemic (whole-body) drug treatment for HCC; more than 2 prior procedures to block blood supply to the tumour (TACE or embolisation) in the area to be treated; liver surgery or heat-based tumour destruction within 6 months before the planned study treatment; or heat-based tumour destruction within 3 months before the planned study treatment
• People who have previously received immunotherapy treatments (such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or similar drugs) for liver cancer or any other condition
• People who have previously had radiation treatment directed at the liver, including external beam radiation or other radioactive treatments
• People whose blood, liver, or kidney test results fall below required levels (specific thresholds cover red blood cells, white blood cells, platelets, bilirubin, albumin, liver enzymes, creatinine, and blood clotting — confirm with trial site)
• People for whom the angiography procedure (a type of imaging using dye injected into blood vessels) or the catheter procedure used to deliver treatment is medically unsuitable
• People who have had an organ transplant or bone marrow transplant of any kind
• People with a history of a condition that weakens the immune system in a way that makes additional immunotherapy unsuitable (as determined by the treating doctor)
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, and others — though some conditions such as vitiligo, controlled hypothyroidism, mild skin conditions not needing systemic treatment, and diet-controlled coeliac disease may be exceptions (confirm with trial site)
• People who have used immune-suppressing medications in the 14 days before the first study drug dose — though some types of steroids used in specific ways (nasal sprays, inhalers, skin creams, or joint injections) may be exceptions
• People using ongoing steroid treatment at a dose equivalent to more than 10mg per day of prednisone
• People who need steroids to prevent allergic reactions before medical imaging scans or other procedures
• People who have had gastrointestinal (digestive tract) bleeding within the 42 days before joining the study, or who have active bleeding or a bleeding disorder that cannot be corrected — though people with known varicose veins in the oesophagus that have not bled or have been treated may still be eligible (confirm with trial site)
• People who have had a biliary stent (a tube placed in the bile duct) or a bile duct procedure called sphincterotomy within the year before joining the study
• People who have had another cancer within the past two years — though some low-risk or fully treated cancers may be exceptions (confirm with trial site)
• People who have had major surgery in the 42 days before joining the study
• People with a history of severe allergy or intolerance to contrast dyes, sedatives, pain medications, or atropine that cannot be medically managed
• People with a known allergy or sensitivity to any of the study drugs or their ingredients that cannot be managed medically
• People with active infections including tuberculosis, hepatitis B combined with hepatitis D, or HIV combined with hepatitis C or hepatitis B — though people with well-controlled HIV, well-controlled hepatitis B, or well-controlled hepatitis C infection may still be eligible under certain conditions (confirm with trial site)
• People who have received a live vaccine in the 30 days before the first study drug dose
• People who have taken part in another clinical trial involving an active treatment in the 4 weeks before joining this study (observational studies or follow-up-only phases may be acceptable — confirm with trial site)
• People who are pregnant or breastfeeding and do not wish to stop breastfeeding, and people of reproductive capacity who are not willing to use effective contraception from the start of the study until at least 3 months after the last dose of study treatment
• People with an unstable or serious health condition that the treating doctor considers would make the study treatments unsafe
• People who would not be able to follow the requirements of the study treatments
• People who are detained by legal or administrative order, receiving certain forms of compulsory psychiatric care, admitted to a health or social institution for reasons unrelated to research, or who are under legal guardianship or a similar protective legal arrangement
• People for whom pre-procedure imaging (using specific scan techniques) shows that the radiation treatment would reach the digestive tract and cannot be corrected, shows poor targeting of the tumour or the blocked vein, shows that the required radiation dose targets cannot be met, or shows that too much radiation could reach the lungs

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