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:

• A person must have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC), either confirmed by a tissue or cell sample, or by liver scarring (cirrhosis) combined with characteristic scan findings.
• The liver cancer must have shown limited progression (in 5 or fewer spots and across 3 or fewer organs) after being treated with a type of immunotherapy called a PD-1 drug as the first treatment.
• The cancer must have been stable for at least 3 months while on that first-line PD-1 immunotherapy before the limited progression occurred.
• The cancer must be classified at an advanced stage known as BCLC stage C (confirm with trial site).
• The person must have a good general level of daily functioning, rated 0 or 1 on a standard medical scale (meaning largely able to carry out normal daily activities).
• Life expectancy must be at least 6 months.
• The person must have had no previous radiation therapy.
• The person must be between 18 and 75 years old.
• The person must be willing and able to sign a written consent form agreeing to take part.
• People of childbearing potential, and men whose partners are of childbearing potential, must agree to use effective contraception during treatment and for 6 months after treatment ends.

Who may not be able to join:

• People with certain less common types of liver or bile duct cancer, including fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma.
• People with a history of a brain condition caused by liver failure (hepatic encephalopathy) or who have had a liver transplant.
• People who have fluid build-up around the lungs, abdomen, or heart that is causing symptoms or needs to be drained (small amounts without symptoms may be acceptable — confirm with trial site).
• People with untreated or poorly controlled hepatitis B or C infection above certain levels in the blood.
• People with active cancer spread to the brain or nervous system, unless it has been successfully treated, symptoms have largely resolved for at least 2 weeks, and steroid medication use meets specific conditions (confirm with trial site).
• People who, in the past 6 months, have had a bowel perforation or abnormal opening (fistula), bowel blockage, inflammatory bowel disease, major bowel removal surgery, Crohn's disease, ulcerative colitis, or ongoing diarrhoea.
• People with a history of significant lung scarring (interstitial lung disease) or other lung conditions that could complicate monitoring for possible drug-related lung side effects.
• People with active tuberculosis (TB), or those diagnosed with active TB within the past year even if treated.
• People who test positive for HIV or have AIDS.
• People with a serious active infection, or those who were hospitalised for a severe infection, blood infection, or serious pneumonia within the 4 weeks before starting treatment.
• People with active autoimmune diseases (some milder autoimmune conditions, such as vitiligo, type 1 diabetes, stable thyroid conditions managed with hormone replacement, or conditions unlikely to flare without a trigger, may still be eligible — confirm with trial site).
• People who have received any vaccine to prevent infection (such as flu or chickenpox vaccines) within the past 4 weeks.
• People who have had major surgery (such as brain, chest, or abdominal surgery) in the past 4 weeks, or who have wounds, ulcers, or fractures that have not healed.
• People with uncontrolled metabolic conditions or other serious non-cancer organ or system diseases.
• People with certain acute or chronic illnesses, psychiatric conditions, or abnormal blood test results that researchers determine would make participation unsafe or interfere with trial results.
• People who have been diagnosed with another cancer within the past 5 years, with the exception of certain fully treated skin cancers or in-situ cancers (confirm with trial site).
• People who are pregnant or breastfeeding.

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