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 aged between 18 and 80 years old, of any gender
• People who had surgery to fully remove liver cancer between 4 and 8 weeks before joining the trial, where the surgery met specific requirements: no visible tumour spread into major blood vessels, bile ducts, or nearby organs; no spread to lymph nodes or distant parts of the body; and the surgeon removed a sufficient margin of healthy tissue around the tumour
• People whose post-surgery scans (at least two of: ultrasound, CT, or MRI) show no remaining or returning tumour, done 1 to 2 months after surgery
• People whose blood tumour markers (such as AFP) that were elevated before surgery have returned to normal levels within 8 weeks of surgery
• People whose tissue sample from surgery was confirmed by laboratory testing to be hepatocellular carcinoma (a specific type of liver cancer), with all tumour tissue fully removed and clear margins
• People whose scans done at least 4 weeks after surgery show no signs of the cancer returning or spreading
• People with an expected survival of more than 3 months
• People with a hepatitis B viral load below a certain level (10⁴ copies/ml or 2000 IU/ml); people above this level may still be considered after antiviral treatment brings the level down (confirm with trial site)
• People who have at least one of the following higher-risk features: tumour larger than 5cm; more than 3 tumour spots; laboratory findings showing a specific type of blood vessel invasion (called MVI positivity); an aggressive tumour grade (Edmondson grade III or IV); or AFP levels that remain abnormal after surgery
• People with no history of other cancers and no anti-cancer treatment before this surgery
• People with a physical fitness score of 0 or 1 on a standard scale (meaning fully active or able to carry out light activity)
• People whose blood counts, liver function, kidney function, and clotting results are within acceptable ranges on tests done within 14 days before joining (without recent blood transfusions, certain blood-boosting medications, or albumin infusions)
• People of reproductive capacity who are willing to use reliable contraception during the treatment period and for 60 days after the last dose

Who may not be able to join:

• People whose tumour is a mixed type involving both liver cancer and bile duct cancer
• People whose surgical margins were not clear of cancer cells, or whose tumour broke open during surgery
• People who are having a second operation for liver cancer that had already come back
• People who have had another type of cancer within the past 5 years (with some exceptions for certain low-risk skin cancers, superficial bladder cancer, or carcinoma in situ that were successfully treated — confirm with trial site)
• People with a past or current immune system deficiency condition, whether inherited or developed
• People who have previously received an organ or tissue transplant from another person
• People for whom there is not enough biopsy or surgical tissue available for testing
• People who are pregnant or breastfeeding
• People who received certain targeted therapies (such as sorafenib, lenvatinib, or regorafenib) or immunotherapy treatments (such as anti-PD-1 or anti-CTLA-4 drugs) before their surgery
• People who are unable to give informed consent due to language barriers, cognitive ability, or other reasons
• People with active bleeding, abnormal clotting, or who are currently on blood-thinning or clot-dissolving medications
• People who have had gastrointestinal bleeding in the past 4 weeks, or who show signs that suggest a significant risk of gastrointestinal bleeding
• People with significant heart conditions, including a recent heart attack, severe chest pain, heart bypass surgery in the past 6 months, significant heart failure, poorly controlled irregular heartbeat, or blood pressure that remains high despite medication
• People with known allergies to the chemotherapy drugs used in this trial, or other medical reasons that make chemotherapy unsuitable
• People who have had a blood clot event (such as a stroke, deep vein thrombosis, or pulmonary embolism) in the past 6 months
• People who have had a bowel perforation, abdominal fistula, or abdominal abscess in the past 6 months
• People who have not fully recovered from their surgery, such as those with unhealed wounds or serious complications
• People with a history of alcohol, drug, or other substance misuse in the past 6 months
• People with other serious health conditions that the trial doctors consider make participation unsuitable
• People currently taking part in another interventional clinical trial

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