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 have been diagnosed with colorectal cancer (a type of bowel cancer) that has been confirmed by a tissue sample analysis, specifically the type called adenocarcinoma.
• People whose cancer has spread to the liver and cannot be removed by surgery, with the liver being the only or main site of spread, and where the disease can be measured on scans.
• People aged 18 or older at the time of signing the consent form.
• People who are generally well enough to carry out light activity and care for themselves (a doctor will assess this using a standard scale called ECOG, scoring 0 or 1).
• People whose cancer has continued to grow or spread after at least two different rounds of cancer treatment.
• People who are willing to provide tumour tissue samples and blood samples for research purposes.
• People where less than half of the liver has been taken over by cancer, as assessed by the treating doctor.
• People whose blood test results show that the liver, kidneys, blood cells, and clotting system are working well enough, as measured within 14 days before starting treatment (confirm with trial site for specific values required).
• Women who could become pregnant must be willing to use effective contraception from the time of a negative pregnancy test until at least 6 months after the last dose of study treatment, and must be willing to stop breastfeeding at the start of treatment and for 5 months afterwards.
• Men who could father a child must agree to use effective contraception with female partners who could become pregnant, during the study and for up to 3 months after the last dose of study treatment.
• People who are able to understand the study, are willing to sign a consent form, and are able to follow the study procedures.

Who may not be able to join:

• People who have previously had yttrium-90 treatment (a type of radiation delivered to the liver through blood vessels).
• People who have previously had external beam radiation therapy directed at the liver.
• People whose life expectancy is estimated to be less than 3 months.
• People whose cancer has certain genetic features: mismatch repair deficiency (dMMR), high microsatellite instability (MSI-H), or a high number of tumour mutations (TMB-H, defined as 10 or more mutations per megabase) (confirm with trial site).
• People whose cancer has spread to the lining of the abdomen or to the brain, with some limited exceptions for small, stable, symptom-free brain spots (confirm with trial site).
• People who have received another experimental treatment within 28 days before starting this study.
• People who have received standard cancer treatment within 14 days, or within 5 half-lives of that drug (whichever is longer), before starting this study.
• People who have previously been treated with certain types of immunotherapy drugs, including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or CD137-stimulating drugs.
• People with a medical condition, enzyme deficiency (such as DPD deficiency), or lab result that the treating doctor believes could interfere with the study or put the person at risk.
• People with serious heart problems, including severe heart failure, a heart attack within the past 6 months, unstable chest pain, or an unstable irregular heartbeat; or people with a known very low heart pumping function (confirm with trial site).
• People with severe chronic lung disease (COPD) that requires regular steroid tablets or ongoing oxygen therapy.
• People with a history of most autoimmune diseases (conditions where the immune system attacks the body), though some well-controlled conditions such as stable thyroid disease, well-managed asthma using only inhalers, stable type 1 diabetes, or minor skin conditions may be acceptable (confirm with trial site).
• People who have taken immune-suppressing medications (such as steroids or certain other drugs) within 2 weeks before starting the study, or who are expected to need them during the study, with some limited exceptions for short-term or low-dose use (confirm with trial site).
• People who test positive for HIV, either at screening or with a known prior positive result.
• People with an active hepatitis B infection, as shown by a positive surface antigen test at screening.
• People with an active hepatitis C infection, confirmed by both a positive antibody test and a positive RNA test at screening.
• People with active tuberculosis (TB).
• People who have received a live vaccine within 28 days before starting the study treatment, or who are expected to need one during the study or within 5 months of finishing treatment.
• People with a history of severe allergic reactions to certain types of laboratory-made antibody drugs, or a known allergy to any ingredient in the study drug atezolizumab.
• People who are unable to swallow medication.
• People with a history of another cancer that could affect how the study results are measured or interpreted, unless that cancer was treated successfully and is fully under control (confirm with trial site).
• People with a current active infection (bacterial, viral, fungal, or other), or who were hospitalised for a serious infection or needed intravenous antibiotics within 28 days before the first dose.
• People who have had major surgery or a serious injury within 28 days before starting the study, or who are expected to need major surgery during the study.
• People with other significant uncontrolled medical or mental health conditions that could affect their ability to follow the study procedures.
• People who are currently pregnant, breastfeeding, or who are in prison.
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal disease).
• People with cancer-related pain that is not well controlled.
• People who need pain medication must be on a stable dose before entering the study.
• People who have painful tumour spots that could be treated with palliative radiation should have that treatment before enrolling, and should have recovered from its effects.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained once a month or more often (though people with a permanent drainage tube in place may be eligible — confirm with trial site).
• People with uncontrolled or symptomatic high calcium levels in the blood (confirm with trial site for specific values).
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or unexplained lung inflammation, or those with signs of active lung inflammation on a recent CT scan.
• People who have had a stem cell transplant or a solid organ transplant from a donor.
• People with any other medical finding, test result, or condition that the treating doctor believes would make the study drugs unsafe or make the results difficult to interpret.
• People who have received immune-stimulating drugs (such as interferon or IL-2) within 4 weeks, or within 5 half-lives of that drug (whichever is longer), before starting the study.

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