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 liver cancer (hepatocellular carcinoma, or HCC) — either confirmed by tissue sample, or in some cases by imaging scans that meet specific medical guidelines — and whose cancer has continued to grow during or after treatment with certain immunotherapy drugs (such as nivolumab, pembrolizumab, or atezolizumab), or who have not yet received that type of immunotherapy. Note: prior treatment with a drug called durvalumab makes a person ineligible.
• People who have at least one measurable tumour that has not previously been treated with radiation therapy or other local treatments.
• People whose cancer gives doctors a medical reason to use radiation therapy — for example, to relieve pain or to prevent a blockage in a blood vessel or bile duct.
• People whose liver function falls within a specific scoring range (Child-Pugh score of A, B7, or B8), provided other liver test results also meet the required levels.
• People whose general health and ability to carry out daily activities meet a specific performance standard (ECOG score of 0 or 1, meaning fully active or able to do light work).
• People with hepatitis B virus (HBV) who are receiving appropriate antiviral treatment and whose HBV viral levels are below a specified threshold.
• People whose blood counts and organ function test results meet the required levels, including haemoglobin, white blood cell counts, platelets, liver enzymes, kidney function, and blood clotting measures.
• People who have no medical reason preventing them from receiving immunotherapy or radiation therapy.
• People aged 18 or older at the time of joining the study.
• People with a life expectancy of at least 12 weeks.
• People who weigh more than 30 kg (approximately 66 pounds).
• Women who are post-menopausal (based on specific age-related criteria) or who have a negative pregnancy test before joining.
• Women who are able to become pregnant, and men, who are willing to use effective contraception from the screening period throughout participation in the study and for a defined period after the last dose of study drugs.
• People who are willing and able to attend all required visits and follow the study schedule.
• People who are able to give written informed consent and understand what participation involves.

Who may not be able to join:

• People who have previously had radiation therapy to the tumour sites being considered for treatment in this trial, where additional radiation could be unsafe.
• People who have previously had radiation therapy to more than 30% of their bone marrow, or who had a large area of the body irradiated within the past 4 weeks.
• People who have previously been treated with a type of immunotherapy that targets CTLA-4 or PD-L1 pathways.
• People who have previously had an organ transplant from another person (allogeneic transplant).
• People who previously received a PD-1 immunotherapy drug and experienced serious side effects (grade 3 or higher) from it, had side effects that have not returned to near-normal levels, or currently need more than a low daily dose of steroid medication (more than 10 mg prednisone or equivalent) to manage those side effects.
• People who have had major surgery, liver-directed treatment, or any other cancer treatment within the 4 weeks before joining the trial.
• People who still have unresolved side effects from previous cancer treatment that are moderate or severe (grade 2 or higher), with some exceptions such as hair loss or skin colour changes.
• People who are currently enrolled in another interventional (treatment-testing) clinical trial.
• People who participated in another interventional clinical trial involving an experimental product within the past 4 weeks.
• People with a current or past history of certain autoimmune or inflammatory conditions (such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar conditions), with some exceptions such as well-controlled thyroid conditions or certain skin conditions not requiring systemic treatment.
• People with serious uncontrolled health conditions, such as active infections, uncontrolled heart conditions, uncontrolled high blood pressure, serious lung disease, severe ongoing diarrhoea, or significant mental health or social circumstances that would affect safe participation.
• People who have had another type of cancer in the past, unless it was treated with curative intent, has shown no signs of returning for at least 2 years, and carries a low risk of coming back. Certain skin cancers and non-invasive cancers that have been fully treated are exceptions.
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis).
• People with a history of a primary immune deficiency condition.
• People with an active infection, including active tuberculosis.
• People known to have HIV infection.
• People who have used immunosuppressive medications within 14 days before the first dose of study drugs, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions before scans.
• People who have received a live attenuated vaccine within 30 days before starting the study drugs.
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception for the required period.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have previously taken part in a clinical trial involving durvalumab and/or tremelimumab.
• People involved in planning or running this trial.
• People who, in the opinion of the investigating doctor, have any other condition that makes participation in the trial unsuitable.

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