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 signed an informed consent form agreeing to participate.
• People who are 18 years of age or older at the time of giving consent.
• People who have been diagnosed with a specific type of colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body), confirmed by laboratory testing, and whose cancer has a particular molecular profile called MSS or pMMR, and cannot be fully removed by surgery.
• People whose cancer has been tested for specific gene changes (RAS including KRAS and NRAS, and BRAF V600E), with known results.
• People who do not currently have active cancer spread to the liver — including those whose liver metastases were fully treated (by surgery, ablation, or certain radiation techniques) at least 3 months before joining, with no signs of the cancer coming back in the liver since then.
• People who have already received at least one prior treatment for advanced colorectal cancer (which may have included certain chemotherapy drugs and targeted therapies), or who were unable to tolerate or were not suitable for those treatments.
• People whose general physical health and ability to carry out daily activities meets a specific standard (ECOG performance status of 0 or 1, meaning fully active or able to carry out light work).
• People who are expected to live for more than 16 weeks.
• People whose blood, liver, and kidney function results fall within acceptable ranges as determined by specific laboratory tests (confirm details with trial site).
• People whose blood clotting function meets acceptable levels, unless they are already on blood-thinning medication.
• People who are able and willing to use highly effective contraception during treatment and for at least 6 months after the last treatment dose, or remain abstinent — this applies to women who could become pregnant and to men in one of the trial groups whose partners could become pregnant (confirm specific requirements with trial site).
• Women who could become pregnant must have a negative pregnancy test within the 7 days before starting treatment.
• People who are willing and able to follow all study requirements, including attending scheduled visits and check-ups throughout the trial.

Who may not be able to join:

• People who have had a known allergic or hypersensitivity reaction to any of the medications used in the trial.
• People who have had another cancer (other than the one being studied) within the past 3 years, or who currently have another cancer — except for certain low-risk cancers such as non-melanoma skin cancer or adequately treated cervical cancer in situ.
• People who have previously been treated with any of the following medications: fruquintinib, trifluridine/tipiracil, regorafenib, or certain immunotherapy drugs (anti-PD-1 or anti-PD-L1 antibodies).
• People who are currently receiving any anti-cancer treatment (such as chemotherapy, immunotherapy, or hormone therapy) within 2 weeks before the trial treatment is due to start.
• People who are receiving another anti-cancer treatment at the same time as the trial treatment (palliative radiation for symptom relief is allowed).
• People who have cancer that has spread to the brain or the lining of the brain or spinal cord, and has not been treated or is causing symptoms.
• People with significant heart problems, including unstable chest pain or a heart attack within the past 6 months, moderate to severe heart failure, uncontrolled high blood pressure, uncontrolled irregular heart rhythm, active coronary artery disease, or certain abnormal heart electrical readings.
• People with a history of uncontrolled HIV infection, or ongoing hepatitis B or C infection.
• People who have a known tendency to bleed abnormally.
• People who have had a hole (perforation) or abnormal connection (fistula) in their digestive tract in the past 6 months, or who are at high risk of this happening.
• People who have had serious bleeding in their digestive tract within the 3 months before joining the trial.
• People who are currently taking, or have recently taken, certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors) within 2 weeks or longer before starting the trial (confirm specific medications with trial site).
• People who have had major surgery within 2 weeks before the trial treatment is due to start.
• People who previously experienced severe, life-threatening, or repeated serious immune-related side effects or serious reactions during infusion while receiving immunotherapy.
• People who are currently taking high-dose immune-suppressing medications (such as prednisone at more than 10 mg per day or equivalent), unless these have been stopped at least 2 weeks before starting the trial. Lower doses and certain forms of corticosteroids (such as inhaled or injected into a joint) may be permitted (confirm with trial site).
• People who have an active autoimmune disease that has required systemic treatment within the past 2 years, or any condition that currently requires immune-suppressing medication.
• People who have had a solid organ transplant.
• People who have had a blood clot in a vein (such as a deep vein thrombosis or a clot in the lungs) within the past 6 months, or a stroke or mini-stroke within the past 12 months.
• People who have another serious medical condition that, in the treating doctor's judgement, would put them at high risk or make the trial treatment unlikely to be effective.
• Women who are pregnant, breastfeeding, or planning to become pregnant during or within 6 months after the end of treatment.

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