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 given written consent to participate (or whose legal representative has done so on their behalf)
• People who agree to allow the trial to use stored tissue samples from a previous tumor biopsy (exceptions may be possible with approval from the lead researcher)
• People aged 18 or older
• People who are relatively active and able to care for themselves, with only mild limitations on physical activity (as measured by a standard medical scale called ECOG 0–1)
• People who are expected to live for at least 12 weeks
• Women who are post-menopausal (periods stopped for at least 12 months without another medical explanation, or due to surgery, radiation, or chemotherapy), or who have a negative pregnancy test before starting the trial
• Men who are either surgically sterile (vasectomised) or who agree to use effective contraception if their partner could become pregnant
• People who have been diagnosed with metastatic breast cancer (cancer that has spread beyond the breast) and have already received at least one round of chemotherapy for the metastatic disease
• People whose liver tumours are suitable for a liver-targeted radiation treatment called TARE, as confirmed by a specialist doctor, and who have at least one measurable liver tumour
• People whose liver tumours make up less than 50% of the liver
• People with no signs of liver scarring (cirrhosis) on scans or clinical assessment
• People who have other metastases (cancer spread elsewhere in the body) that have been treated and are currently stable — including stable brain metastases
• People who have recovered from most side effects of previous cancer treatments (hair loss is an exception and does not need to have resolved)
• People who weigh more than 30 kg
• People with no active, untreated hepatitis infection
• People whose recent blood test results (taken within 14 days before starting treatment) meet specific levels for: haemoglobin, white blood cells, platelets, bilirubin, liver enzymes, albumin, blood clotting (INR), and kidney function (confirm specific values with the trial site)

Who may not be able to join:

• People who have received immunotherapy treatment within the past 12 months
• People who have cancer that has spread outside the liver and is currently growing or untreated
• People who have an autoimmune disease that requires treatment, a weakened immune system, or any condition requiring immune-suppressing medications
• People with any other health condition that the trial doctor believes would make participation unsafe
• People whose cancer has grown into the main blood vessel supplying the liver (portal vein)
• People whose liver tumours take up more than 50% of the liver
• People who have had major surgery within 28 days before the planned liver radiation treatment
• People who have participated in another clinical trial involving an experimental treatment within the past 4 weeks
• People currently enrolled in another clinical trial that involves an active treatment (observational studies or follow-up periods may be exceptions — confirm with the trial site)
• People who received their last cancer treatment within 28 days before starting the trial drug (a longer waiting period may be needed depending on the treatment — confirm with the trial site)
• People who have received specific immune checkpoint treatments (anti-PD-1, anti-PD-L1, anti-CTLA4 drugs, including cemiplimab) within the past 12 months
• People who still have unresolved side effects at a moderate or severe level from previous cancer treatment (with some exceptions such as hair loss or skin pigmentation changes)
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, and certain others (some exceptions apply — confirm with the trial site)
• People who have previously received an organ transplant from another person
• People for whom the radiation treatment would deliver more than 30 Gy (a unit of radiation dose) to the lungs
• People with serious uncontrolled illnesses, including active infections, heart failure, uncontrolled high blood pressure, unstable heart conditions, lung disease, serious bowel conditions, or mental health or social situations that would make it difficult to follow the study requirements
• People who have had another cancer diagnosis, unless it was treated with curative intent at least 5 years ago with no known return, was a non-melanoma skin cancer or certain pre-cancerous conditions that were fully treated, or is of very low risk of returning (confirm with the trial site)
• People with a history of a primary immune system deficiency, or active HIV/AIDS that is not well controlled
• People who have received a live vaccine within 30 days before starting the trial drug (and should not receive live vaccines during treatment or for 30 days after the last dose)
• People with active systemic (whole-body) infections, including active or latent tuberculosis
• People who have had cancer spread to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis)
• People with a known allergy or sensitivity to the trial drugs or their ingredients
• People currently receiving other chemotherapy, biological therapies, or hormonal cancer treatments at the same time (hormonal therapy for non-cancer reasons, such as menopause management, may be acceptable — confirm with the trial site)
• People who have used immune-suppressing medications within 14 days before the first dose (some exceptions apply, such as low-dose steroids or inhaled/topical steroids — confirm with the trial site)
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the start of the study until at least 4 months after the last dose of the trial drug or the last liver radiation treatment, whichever comes later
• Women who are able to become pregnant and are not willing to use effective contraception as directed by the trial doctor (note: the rhythm method alone is not considered acceptable)
• Men who are not willing to use effective contraception (such as condoms or abstinence, unless vasectomised) during the study and for at least 6 months after the last dose; sperm donation is also not permitted during this period
• People who are unable or unwilling to understand and sign the consent form
• People who, in the trial doctor's opinion, may not be able to follow all study procedures
• People with certain heart conditions, including moderate-to-severe heart failure, a heart attack or acute coronary event within the past 12 months, or a stroke or mini-stroke (TIA) within the past year
• People who need ongoing daily steroid medication above a low threshold dose (more than 10 mg prednisone per day or equivalent) within one week before starting the trial (short courses of steroids of up to 2 days may be acceptable — confirm with the trial site)
• People with ongoing or recent significant autoimmune disease requiring systemic immune-suppressing treatment
• People who have had an infection that required hospitalisation or intravenous antibiotics within 2 weeks before starting the trial
• People with uncontrolled HIV, hepatitis B, or hepatitis C infections, or active or latent tuberculosis (people with well-controlled HIV, hepatitis B, or hepatitis C under specific conditions may be eligible — confirm with the trial site)
• People who have received a live vaccine within 4 weeks of starting the study medication
• People who have received a COVID-19 vaccine within 1 week of the planned start of treatment, or whose COVID-19 vaccine schedule would not be completed at least 1 week before starting treatment
• People who are unwilling or unable to use highly effective contraception as required (a detailed list of accepted contraception methods applies — confirm with the trial site)

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