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:

• Adults aged 18 or older.
• (For liver cancer patients) People with locally advanced, inoperable, returned, or spread liver cancer (hepatocellular carcinoma/HCC), confirmed by biopsy, lab testing, or imaging.
• (For liver cancer patients) People whose liver cancer got worse while receiving their first and only systemic treatment, which must have included an immunotherapy drug such as atezolizumab, bevacizumab, durvalumab, tremelimumab, pembrolizumab, nivolumab, or ipilimumab, as the most recent treatment.
• (For liver cancer patients) People whose liver is still functioning at a level called "Child-Pugh A," confirmed within 14 days before starting the trial treatment.
• People who have at least one tumour measuring 1 cm or more that can be seen and measured on a scan.
• People who have at least one tumour that a doctor can inject directly, measuring at least 1 cm across.
• People willing to provide either a fresh tumour tissue sample (biopsy) or an archived sample taken within the past 90 days.
• People whose blood counts are within acceptable ranges — including white blood cells, infection-fighting cells (neutrophils), platelets, and haemoglobin — without needing ongoing transfusions or growth factor support (confirm specific values with trial site).
• People whose liver function blood test results are within acceptable ranges (confirm specific values with trial site).
• People whose kidneys are working well enough, based on blood or urine tests (confirm specific values with trial site).
• People with a blood protein level (albumin) at or above a minimum threshold (confirm specific value with trial site).
• People whose blood clotting test results are within acceptable ranges (confirm specific values with trial site).
• People who are generally well enough to carry out light activity and care for themselves, as rated by a standard medical scale (ECOG score of 0 or 1).
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use highly effective contraception during the trial and for a set period after the last dose of each study drug (the required period varies by drug — confirm with trial site).
• Men who agree to avoid donating sperm and to use contraception during the trial and for at least 90 days after the last dose of the main study drug.
• Women who could become pregnant must have a negative pregnancy blood test within 72 hours before the first dose, and a negative urine pregnancy test on the day of the first dose.
• People who are able and willing to give informed consent and follow the trial requirements.
• (For bile duct cancer patients) People with confirmed, inoperable or spread cancer of the bile ducts or gallbladder (biliary tract cancer/BTC) whose disease has not worsened during a combination treatment of gemcitabine, a platinum-based chemotherapy, and an immunotherapy checkpoint inhibitor, given for between 12 and 24 weeks, with certain specific conditions around the duration and sequencing of those treatments (confirm full details with trial site).

Who may not be able to join:

• (For liver cancer patients) People whose liver function is rated Child-Pugh B or C.
• (For liver cancer patients) People with untreated or incompletely treated swollen veins in the food pipe or stomach that are bleeding or at high risk of bleeding.
• People who have had a significant bleeding event in the past 12 months that would make direct injection into a tumour too risky, in the treating doctor's judgement.
• (For liver cancer patients) People whose cancer has grown into major blood vessels near the liver or into the main bile duct.
• (For liver cancer patients) People with certain rare or unusual types of liver cancer, as confirmed by biopsy.
• People with a history of a severe liver-related brain condition (hepatic encephalopathy) that did not respond to treatment, or a condition where the kidneys fail because of severe liver disease (hepatorenal syndrome).
• People whose cancer could potentially be removed by surgery or treated with local procedures aimed at a cure.
• People whose liver tumours are estimated to cover more than one-third of the liver.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that has needed draining within the 7 days before joining.
• People with hepatitis B virus levels above a certain threshold in the blood, or those with both hepatitis B and hepatitis C infections at the same time.
• People with a known HIV infection.
• People with an active or significant history of herpes virus infections (such as herpes affecting the eyes or brain), or people who need ongoing antiviral medication that targets the herpes virus.
• People with a serious active infection that requires antibiotic treatment through a drip (IV) within 14 days before the first dose.
• People who have received a live vaccine within 28 days before the first dose.
• People with known cancer that has spread to the brain or the lining around the brain or spinal cord.
• People who have had another cancer (other than the cancer being treated in this trial) that was active within the past 3 years — with exceptions for certain low-risk or fully treated skin cancers and other localised cancers that appear cured or are only being monitored (confirm with trial site).
• People currently taking part in, or who have recently taken part in, another clinical trial using an experimental drug or device within the past 4 weeks.
• People who have received other cancer treatments within 4 weeks before the first trial dose, unless they have recovered from any side effects.
• People who have received radiotherapy within 2 weeks before starting the trial, or who have not recovered from radiation side effects.
• People who have previously been treated with an oncolytic virus therapy (a treatment that uses a modified virus to target cancer).
• People with a history of significant heart problems, including severe heart failure, unstable chest pain (angina), serious uncontrolled heart rhythm problems, or a heart attack within the past 6 months.
• People with certain lung conditions, including lung scarring, certain types of lung inflammation, or active signs of lung inflammation on a recent scan.
• People with active tuberculosis.
• People with significant psychiatric conditions, substance use disorders, or other serious medical conditions that, in the investigator's view, could affect safety or study participation.
• People with any other condition or medical history that the investigator believes would make participation unsafe or interfere with the study.
• People with an active autoimmune disease that currently requires treatment affecting the whole body — though certain manageable conditions such as controlled type 1 diabetes, thyroid conditions managed by hormone replacement, and some skin conditions not requiring systemic treatment may still be eligible (confirm with trial site).
• People currently taking high-dose steroid medication (above 10 mg per day of prednisone or equivalent) within 14 days before the first dose — with some exceptions for short courses or low replacement doses (confirm with trial site).
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have had a life-threatening reaction to a previous immunotherapy treatment — unless the reaction is unlikely to happen again or is considered manageable (confirm with trial site).
• (For liver cancer patients) People who have used aspirin, certain blood-thinning medications, or full-dose anticoagulant (clot-preventing) medicines within 10 days before the first dose.
• People who have used herbal supplements or traditional medicines intended to treat their cancer or support general health within 2 weeks before starting treatment.
• People who have previously had an organ transplant or a stem cell transplant from a donor.
• (For liver cancer patients) People who have had major surgery within 28 days before starting a study drug called bevacizumab, or who are expected to need major surgery during the trial.
• (For bile duct cancer patients) People with a specific type of cancer called ampullary carcinoma, or a mixed cancer involving both bile duct cancer and liver cancer.
• (For bile duct cancer patients) People whose cancer has a specific genetic feature known as mismatch repair deficiency or microsatellite instability-high (MSI-H).

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