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:

For people with liver cancer (hepatocellular carcinoma / HCC):

• People who have been newly diagnosed with liver cancer, or whose liver cancer has come back, confirmed by a biopsy or by standard medical imaging criteria, where surgery (with or without ablation) is planned with the aim of curing the cancer
• People whose liver cancer meets specific size and number requirements: either up to three tumours with at least one larger than 3 cm, or more than three tumours where none is larger than 5 cm
• People whose liver cancer has returned after previous curative treatment (such as surgery or ablation), as long as the cancer is only in the liver and meets the size and number criteria above
• People with a Child-Pugh liver function score of 5 or 6 (a measure of how well the liver is working — confirm with trial site)
• People who have had imaging scans within the past 12 weeks confirming the cancer has not spread outside the liver

For people with bowel cancer that has spread to the liver (colorectal liver metastases / CRLM):

• People with bowel cancer that has spread only to the liver, confirmed by imaging scans done within the past 12 weeks
• People whose liver metastases are planned for curative surgery, with or without ablation
• People whose original bowel cancer tumour has already been removed or is planned to be removed
• People who have received chemotherapy around the time of surgery, or who are planned to receive chemotherapy after surgery
• People with rectal cancer who have received or are planned to receive radiation therapy alongside surgery

General criteria for all participants:

• People whose liver cancer is not related to viral hepatitis, or whose liver cancer is related to hepatitis B or C, provided specific conditions are met regarding whether the infection is resolved or being treated (confirm with trial site)
• People who are generally well enough to carry out daily activities with no or only minor limitations (ECOG performance status of 0 or 1 — confirm with trial site)
• People whose recent blood test results fall within the required ranges for blood cell counts, liver function, kidney function, and blood clotting (confirm with trial site for specific values)
• People aged 21 or older
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting treatment
• Women who could become pregnant must agree to use an approved form of contraception during treatment and for 7 months after the last dose
• Men who are sexually active with women who could become pregnant must also agree to use an approved form of contraception during treatment and for 7 months after the last dose, and must not donate sperm during this time

Who may not be able to join:

For people with liver cancer (HCC):

• People with specific rare subtypes of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• People whose cancer has spread to other parts of the body, or who have another active cancer at the same time
• People whose imaging scans show the cancer has grown into major blood vessels in the liver
• People who have previously had a liver transplant or are currently on a waiting list for one
• People who have previously received any systemic cancer drug therapy, or liver-directed treatments such as TAE, TACE, SIRT, or SBRT for their liver cancer

For people with bowel cancer spread to the liver (CRLM):

• People whose bowel cancer has spread to places in the body other than the liver

General exclusion criteria for all participants:

• People with an active infection of both hepatitis B and hepatitis C at the same time, or hepatitis D alongside hepatitis B
• People who have tested positive for HIV or have AIDS
• People with a serious or uncontrolled medical condition that the trial doctor believes could make participation unsafe or affect the results
• People with an active autoimmune disease (certain conditions such as type 1 diabetes, thyroid conditions requiring only hormone replacement, or skin conditions not needing systemic treatment may still be eligible — confirm with trial site)
• People currently taking corticosteroids at doses above 10 mg of prednisone per day, or other medicines that suppress the immune system, within 14 days before starting the trial (some exceptions may apply — confirm with trial site)
• People who have had another cancer within the past 3 years, unless it was a type considered easily curable and apparently cured, such as certain skin cancers, superficial bladder cancer, or early-stage cancers of the prostate, cervix, or breast
• People who are currently receiving or expected to receive interferon-based therapies during the trial
• People who have previously been treated with certain immunotherapy drugs that target immune checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 treatments)
• People who have used herbal supplements, traditional medicines, or botanical preparations within 2 weeks before starting treatment
• Women with a positive pregnancy test
• Women who are currently breastfeeding
• People with a history of severe allergic reaction to a monoclonal antibody medicine
• People with a known allergy or sensitivity to the components of the study drug
• People who are currently in prison or detained against their will
• People who are being held involuntarily for treatment of a psychiatric or physical illness

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