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 are willing to take part and able to sign a consent form agreeing to join the study
• People aged between 18 and 75 years old, of any gender
• People whose liver is functioning at a level that doctors classify as "Child-Pugh class A" (a measure of how well the liver is working)
• People whose liver has passed a specific dye test showing good function (a test called ICGR-15 must show a result below 15%)
• People who are fully active or have only minor restrictions in daily activity (based on a standard scale doctors use called ECOG, scored 0 or 1)
• People diagnosed with liver cancer (hepatocellular carcinoma) according to 2022 Chinese guidelines, with an expected survival of more than 4 months
• People who were initially diagnosed with liver cancer that could not be removed by surgery (at a stage called BCLC B or C), who then received 2 months of treatment with a combination of TACE (a procedure to block blood supply to the tumour), Lenvatinib (a tablet medicine), and Sintilimab (an immunotherapy medicine), and whose cancer either partially responded or stayed stable during that treatment — and who have between 1 and 3 remaining active tumour spots in the liver that may be suitable for radiation therapy
• People whose surrounding healthy tissue can safely receive radiation within accepted safety limits
• People who have not previously received any targeted therapy, immunotherapy, radiotherapy, or chemotherapy for their cancer before joining the trial
• People who have at least one tumour that can be measured on a scan (measuring 10mm or more in diameter), and that tumour has not previously been treated with localised treatments like radiotherapy or freezing therapy
• People whose blood test results meet minimum levels: enough white blood cells (neutrophils ≥1.5×10⁹/L), haemoglobin ≥8.5g/L, and platelets ≥75×10⁹/L
• People with no history of serious heart rhythm problems or heart failure, no serious breathing problems or severe lung infection, and whose kidneys are working adequately (creatinine clearance above 40 mL/min)
• Women of childbearing age who agree to use contraception during the treatment period and for 6 months after, have had a negative pregnancy test within 7 days before joining, and are not breastfeeding; men who agree to use contraception during the study and for 6 months after it ends

Who may not be able to join:

• People whose liver cancer did not respond to or worsened during the 2-month combination treatment (classified as complete response or progressive disease by the measurement standard called RECIST 1.1)
• People whose cancer has spread into the large vein below the heart (inferior vena cava) or has spread to areas outside the liver
• People who received other anti-cancer treatments — such as targeted medicines, immunotherapy, surgery, TACE, radiotherapy, or certain chemotherapy — before entering the study (note: this overlaps with an inclusion requirement — confirm with trial site)
• People who have had an allergic reaction to Lenvatinib, Sintilimab, or any of their ingredients
• People whose tumour makes up two-thirds or more of the total liver volume, or where tumour spots are spread widely throughout the liver
• People who have an active autoimmune disease (where the immune system attacks the body), or a condition expected to flare up — such as lung inflammation, colitis, hepatitis, or others; however, people with stable thyroid conditions treated with a steady dose of hormone replacement, or stable Type 1 diabetes managed with a steady dose of insulin, may not be excluded (confirm with trial site); people with vitiligo or childhood asthma/allergies that no longer need treatment are not excluded
• People with a history of immune system deficiency, or who have been taking medicines that suppress the immune system (including steroid-based medicines) within the 2 weeks before signing the consent form
• People with a known tendency to bleed or form blood clots (such as haemophilia), or who are currently using or have recently used (within 10 days before starting treatment) full-dose blood-thinning or clot-dissolving medicines — low-dose aspirin or low-molecular-weight heparin used for prevention is permitted
• People who have had a serious infection (such as severe pneumonia, blood infection, or other significant infectious illness) within 4 weeks before starting the study drug, or who show signs of active lung inflammation or infection within 2 weeks before starting, or who need antibiotic treatment (other than preventive use)
• People whose urine test shows significant protein in the urine (1+ or more), confirmed by a 24-hour urine test showing 1g or more of protein
• People who have had another cancer in the past 5 years or currently have another cancer — except for certain skin cancers, cervical carcinoma in situ, or papillary thyroid cancer that have been fully treated and cured
• People with a diagnosed mental health condition, or a history of substance abuse, alcohol dependence, or drug addiction
• Women who are pregnant or breastfeeding
• People who, in the treating doctor's judgement, have clear medical reasons that make surgery or participation in a trial unsafe, such as significant kidney, heart, or lung problems

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