Phase 3 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 are willing and able to sign and date a written consent form before any study-related procedures begin.
• People who have a specific type of colorectal cancer (bowel cancer) that is classified as pMMR/MSS — a subtype identified through laboratory testing.
• People aged between 18 and 75 years.
• People who have colorectal cancer that has spread to the liver (confirmed by tissue or cell testing), with or without a small number of other spread sites outside the liver, and whose cancer has been assessed by a specialist surgical team as not suitable for immediate surgery to remove all liver tumours.
• People whose liver tumours can be measured on scans and are no larger than 6 cm across at their widest point.
• People who have not had radiation therapy to the liver before, or whose liver tissue near the planned radiation area has not been previously treated with radiation, and who have enough healthy liver tissue remaining outside the treatment area (at least 700 cc).
• People who have previously had liver surgery, chemotherapy, local tumour destruction therapy, or chemotherapy delivered directly to the liver — provided at least 2 weeks have passed since that treatment ended.
• People whose liver function is rated as Child-Pugh Class A (a measure of how well the liver is working).
• People whose general physical fitness and ability to carry out daily activities is rated as ECOG 0 or 1 (broadly meaning fully active or able to carry out light activity).
• People whose blood counts, liver function, and kidney function fall within acceptable ranges, as tested within 15 days before starting treatment.
• People with no history of other cancers, who are not pregnant or breastfeeding, and who agree to use effective contraception during the study and for 6 months after the last treatment dose.
• People who are expected to live for at least 6 months.

Who may not be able to join:

• People with active hepatitis, liver cirrhosis, or a liver function rating of Child-Pugh Class B or C.
• People whose cancer has spread to the bones or brain, or who have 3 or more lung tumours that cannot be surgically removed.
• People whose liver tumours cannot be measured on scans.
• People with a history of severe allergic reactions to certain chemotherapy drugs, including platinum-based agents, 5-FU, leucovorin (LV), or a type of anti-nausea medication (5-HT3 receptor antagonists).
• People who have taken part in, or are currently taking part in, another clinical trial within the past 4 weeks.
• People who have previously been treated with certain types of immunotherapy drugs that target immune checkpoint pathways (such as anti-PD-1, PD-L1, PD-L2, or CTLA-4 therapies).
• People with significantly abnormal levels of electrolytes (salts and minerals) in the blood.
• People with certain active digestive tract conditions, such as active stomach or bowel ulcers, ulcerative colitis, tumours that are actively bleeding, or certain unhealed surgical connections between the bowel and nearby organs (unless a stoma has been created and there are no active symptoms).
• People who have had a blood clot in an artery or deep vein within the past 6 months, or who have had bleeding or signs of a bleeding tendency within the past 2 months.
• People who are pregnant or breastfeeding, or who test positive for pregnancy before the first dose, or who are unwilling to use strict contraception during the study (this also applies to their partners).
• People who have an active autoimmune disease that has required treatment with immune-modifying or immunosuppressive medicines in the past 2 years.
• People who have another active cancer (except for cancers that were treated with the aim of a cure and have shown no signs of return for more than 3 years, or certain very early-stage cancers that can be fully treated).
• People with significant heart problems, including severe heart rhythm abnormalities, active coronary artery disease, severe or unstable chest pain, a recent heart attack, or moderate-to-severe heart failure, occurring within the 12 months before joining the study.
• People with an active infection causing a temperature above 38°C.
• People with poorly controlled high calcium levels, high blood pressure, or diabetes.
• People with serious lung conditions, such as lung scarring (fibrosis), inflammation of lung tissue (interstitial pneumonia), or severe emphysema.
• People with psychiatric conditions that could affect their ability to take part in the trial, or a history of diseases affecting the central nervous system (brain and spinal cord).
• People with serious complications such as bowel obstruction, kidney failure, liver failure, or stroke-related conditions.
• People who still have side effects from previous treatments rated at a moderate level or above (CTCAE Grade 2 or higher), except for anaemia, hair loss, or skin colour changes.
• People with any unstable health condition that could affect their safety or ability to follow the study requirements.
• People who the trial investigator considers unsuitable for participation for any other reason.

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