Phase 1 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.
• People who are able to understand, sign, and date a consent form before any trial procedures begin.
• People who are willing and able to follow the study schedule, attend visits, and provide the required samples as set out in the trial plan.
• People who have had their liver cancer (HCC) confirmed through a tissue or pathology test.
• People whose cancer has been assessed by a specialist team and liver surgeon as not suitable for surgery or liver transplant (classified as advanced HCC, BCLC stage C).
• People whose cancer has either stopped responding to standard first-line treatment, who could not tolerate it, or who have declined it, and whose doctors consider them suitable to receive the study drugs (Nivolumab by drip into a vein, and Ipilimumab delivered directly into the liver's blood supply).
• People who have active liver cancer that is still present inside the liver, where at least part of the cancer has not already been treated with local procedures such as chemoembolisation or targeted injections.
• People with or without an active hepatitis B or C infection, provided any active infection is being adequately treated and controlled.
• People who have measurable cancer that can be assessed using standard imaging criteria (mRECIST).
• People with a general health status rated as 0 or 1 on a standard scale used by doctors to measure how much a condition affects daily activity (confirm with trial site).
• People expected to live for at least 12 weeks from the time of signing the consent form, based on the doctor's assessment.
• People whose blood tests show that key organs (including blood cells, kidneys, liver, and thyroid) are functioning at an adequate level as defined by the trial (confirm with trial site for specific values).
• People with well-compensated liver disease, classified as Child-Pugh A, with no history of brain confusion caused by liver disease (hepatic encephalopathy) and no significant fluid build-up in the abdomen (ascites).
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining, and must agree to use two forms of contraception (one being a barrier method such as a condom) or to avoid sexual activity during the trial and for at least 5 months after the last dose of the study drug.
• Men who are sexually active must agree to use a condom during the trial and for at least 7 months after the last dose; it is also recommended that their partner use a highly effective form of contraception for the same period.
• People who agree to have a tumour biopsy taken before treatment begins and during treatment, and who have a tumour that is accessible for biopsy.
• People whose side effects from any previous treatment have recovered to a mild or baseline level (confirm with trial site).
• People who are enrolled in a social security or equivalent health coverage system (this criterion appears specific to the country where the trial is being conducted — confirm with trial site).

Who may not be able to join:

• People who have had another type of cancer in the past, unless it was treated more than 2 years ago with the intent to cure, there is no sign of it returning, and the treating doctor considers the risk of it coming back to be low.
• People with an active autoimmune disease (where the immune system attacks the body) or a known history of autoimmune disease — with some exceptions for certain well-controlled conditions such as vitiligo, controlled asthma, or controlled thyroid conditions (confirm with trial site for specific exceptions).
• People with an existing health condition that, in the doctor's view, would make it unsafe to receive the study drugs or would prevent them from completing the trial.
• People who need oxygen supplementation every day.
• People who have had a heart attack, unstable chest pain, heart bypass surgery, serious heart failure, stroke, or a mini-stroke within the 6 months before joining the trial.
• People who have had encephalitis (brain inflammation), meningitis, or uncontrolled seizures in the year before signing the consent form.
• People who have HIV with AIDS. People with HIV that is well-controlled on medication and with normal immune cell levels may be considered eligible by the doctor (confirm with trial site).
• People who have an active infection currently being treated with antibiotics, antiviral, or antifungal medicines within 7 days before joining.
• People with any other significant ongoing or sudden medical, psychiatric, or social condition that the doctor considers a concern.
• People who are unable to have both a vein line and an arterial line (a tube placed in an artery) inserted, based on pre-treatment scans.
• People taking corticosteroid medicines (such as prednisone) at doses of 10 mg per day or more, or equivalent doses of similar medicines, whether taken as tablets or applied to the skin.
• People who have received, within 4 weeks or 5 half-lives (whichever is shorter) before joining, or who plan to receive during the trial: another experimental drug; any cancer treatment including chemotherapy, biological therapies, radiation, or hormone therapy; live virus vaccines; allergy desensitisation treatment; certain blood cell growth factor medicines; major surgery; or bone-related medicines such as bisphosphonates (confirm with trial site).
• People who have previously had a bone marrow transplant from a donor, or a solid organ transplant, and are currently taking medicines to suppress the immune system as a result.
• People with a known history of a serious allergic reaction to the types of medicines used in this trial (confirm with trial site for specific details).
• People who currently have, or have previously had a severe lung inflammation (pneumonitis) graded 3 or 4 that was caused by immunotherapy treatment.
• People who are under legal guardianship, have had their freedom restricted by a legal or administrative decision, or are unable to give their own consent.
• Women who are pregnant or breastfeeding.

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