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:

• People aged 18 years or older.
• People who have been diagnosed with one of four specific cancer types — kidney cancer (renal cell carcinoma with clear cell component), liver cancer (hepatocellular carcinoma), stomach or oesophageal cancer (gastroesophageal cancer), or uterine cancer (endometrial cancer) — where the cancer is advanced, has spread, and has either stopped responding to standard treatments or no effective standard treatment is available.
• For kidney cancer: people whose cancer has clear cell features, has progressed after receiving at least 2 doses of a specific type of immunotherapy (a PD-1 or PD-L1 treatment), and who have also previously received a type of targeted therapy called a tyrosine kinase inhibitor (TKI).
• For liver cancer: people whose cancer has progressed after at least 2 doses of a PD-1 or PD-L1 immunotherapy, and who have previously received one of these specific treatment combinations: ipilimumab + nivolumab, tremelimumab + durvalumab, atezolizumab + bevacizumab, or lenvatinib + pembrolizumab. Liver function must also meet specific criteria assessed by doctors (Child-Pugh A or Child-Pugh B7).
• For stomach or oesophageal cancer: people whose cancer has progressed after at least 2 doses of a PD-1 or PD-L1 immunotherapy, and who have previously received platinum-based chemotherapy.
• For uterine cancer: people who have received at least one cycle of platinum-based chemotherapy. This includes people with newly diagnosed advanced uterine cancer that still has remaining areas of disease after standard treatment with surgery and chemotherapy, with or without radiotherapy. It also includes people whose tumours have a specific genetic feature (MSI-high or dMMR) and whose cancer has progressed after at least 2 doses of a PD-1 or PD-L1 immunotherapy.
• People who have at least one area of cancer that can be measured on scans, and where that area has not previously been treated with radiation.
• People who are considered well enough to carry out daily activities with no or only minimal limitations, as assessed by a standard doctor rating scale (ECOG performance status 0 or 1).
• People whose blood, liver, kidney, and heart function meet specific minimum levels as determined by blood tests and heart scans (confirm specific values with trial site).
• Women who are not able to become pregnant (due to surgery or being at least 2 years past menopause), or who agree to use two reliable forms of contraception — or abstain from sex — throughout the study and for 4 months after the last dose. Men who are not able to father children, or who agree to use contraception (condoms with spermicide) for the same period.
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose.
• People whose previous cancer treatments, radiation, surgeries, blood transfusions, or biopsies were completed a minimum number of days before the first dose (specific timeframes apply — confirm with trial site).
• People whose side effects from previous cancer treatments have resolved to a mild level or better (with the exception of hair loss).
• People who are able to understand the trial requirements and are willing to follow the study procedures.
• People who have read, understood, and signed the official consent form before any screening tests are done.

Who may not be able to join:

• People who had a serious or significant side effect from a previous PD-1 or PD-L1 immunotherapy that caused them to stop that treatment — particularly if the reaction was severe, life-threatening, involved certain organ systems, came back after restarting treatment, or required strong immune-suppressing medicines beyond steroids. In some cases, a past side effect that has fully or mostly settled may be considered, but only after review by the trial's medical team.
• People who have previously had an organ transplant.
• People who have had a blood clot in an artery or vein, a stroke, or a mini-stroke (transient ischaemic attack) within the 6 months before the first dose.
• People who have had another type of cancer within the past 3 years, except for certain common skin cancers or cervical cancer in situ that has already been successfully treated with surgery.
• People with brain or central nervous system cancer spread that is causing symptoms or is not stable. People with stable, symptom-free brain spread that has not required steroids or anti-seizure medication for more than 4 weeks may be considered, but must have brain imaging done during screening.
• People with a significant build-up of fluid around the lungs, abdomen, or heart that is causing symptoms or has needed repeated draining within 14 days of the first dose.
• People whose scans show the tumour is wrapped around major blood vessels, or has areas of significant tissue death, in a way that the doctor believes creates a risk of bleeding.
• People with severe wounds that have not healed, open sores, active ulcers, or untreated broken bones at the time of screening.
• People with a history of serious bleeding problems or significant issues with blood clotting.
• People currently taking blood thinning or clot-dissolving medication at treatment doses within 14 days of the first dose (low-dose preventative heparin is allowed).
• People currently taking high-dose aspirin (more than 325 mg per day) or certain anti-inflammatory medicines (NSAIDs) within 14 days of the first dose.
• People with diabetes that is not well controlled despite optimised treatment.
• People with high blood pressure that remains above 140/90 mmHg even while taking three or more blood pressure medications within 7 days of dosing.
• People who are pregnant or currently breastfeeding.
• People with active hepatitis B, hepatitis C, or HIV infection, with some exceptions: people with hepatitis B that is well controlled on antiviral medication and meets liver function criteria may be considered; people with hepatitis C who have achieved a sustained viral response may be considered; people with HIV whose virus is undetectable may be considered (confirm specifics with trial site).
• People with active hepatitis C infection (positive antibody test and detectable virus in the blood).
• People who have received a live (attenuated) vaccine within 4 weeks before screening, or who plan to receive one during the study.
• People who are currently taking immune-suppressing medicines (other than low-dose topical, nasal, eye, or inhaled steroids, or low-dose replacement steroids for adrenal conditions) within 7 days before starting the study drug.
• People with an active autoimmune disease, or any condition requiring ongoing use of steroids at more than a low daily dose, or other immune-suppressing therapy. People with a past history of autoimmune disease may be considered after discussion with the trial's medical team.
• People with active or previously documented lung scarring conditions (such as idiopathic pulmonary fibrosis), current acute lung disease, lung inflammation, severe breathing difficulties, or a need for continuous oxygen.
• People with significant heart problems, including moderate to severe heart failure, active coronary artery disease, new or unstable chest pain (angina), clinically significant abnormal heart rhythms, or a specific abnormality on a heart tracing (QTc interval above 480 milliseconds).
• People with other medical conditions that, in the opinion of the trial doctors, could interfere with the study or the safety of its results.

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