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 18 to 80 years old, of any gender.
• People who are willing to take part voluntarily, have signed a consent form, and are able to attend follow-up appointments.
• People who have been diagnosed with primary liver cancer (hepatocellular carcinoma) confirmed by tissue testing after surgery, where the surgeon removed the tumour with clear (negative) margins.
• People who have at least one of the following features that raise the risk of the cancer coming back: a tumour 5cm or larger that has grown into small blood vessels; three or more tumours; or cancer that has spread into a specific part of the portal vein (vp1 or vp2 type).
• People whose scans taken 3 to 7 weeks after surgery show no sign of the cancer returning or spreading.
• People with an ECOG performance score of 0 or 1, meaning they are fully active or able to carry out light activities (confirm with trial site).
• People whose doctors estimate they are expected to live at least 3 months.
• People with a Child-Pugh liver function score of 7 or below, indicating relatively preserved liver function (confirm with trial site).
• People who have not had any previous anti-cancer treatment, other than antiviral therapy.
• People who have no cancer that has spread outside the liver or to lymph nodes.
• People whose recent blood and organ function tests fall within acceptable ranges, including adequate levels of blood cells, liver enzymes, kidney function markers, and proteins in the blood (confirm specific values with trial site).

Who may not be able to join:

• People whose tissue testing has confirmed certain less common liver cancer types, such as fibrolamellar, sarcomatoid, or bile duct-related cancers.
• People whose surgery confirmed that cancer cells were found at the edges of the removed tissue, or that the cancer had already spread to lymph nodes or elsewhere in the body.
• People who have had, or currently have, any other type of cancer besides hepatocellular carcinoma.
• People who have a history of a condition where the brain is affected by liver failure (hepatic encephalopathy), or who have had a liver transplant.
• People who have had an allergic reaction to either of the study drugs: Envafolimab or Donafenib.
• People who have ongoing, poorly controlled fluid build-up around the lungs, abdomen, or heart after surgery.
• People who have received previous anti-cancer treatment (other than antiviral therapy).
• People with a history of a lung condition called interstitial lung disease or non-infectious lung inflammation (with a limited exception — confirm with trial site).
• People who have an active autoimmune disease, or a history of autoimmune disease, such as autoimmune hepatitis, lupus, or inflammatory bowel disease, among others (some exceptions may apply — confirm with trial site).
• People who are currently taking, or have taken within the past 2 weeks, immune-suppressing medications or steroids above a certain dose.
• People who have had a serious infection requiring hospitalisation in the 4 weeks before starting the study drug.
• People who have had a heart attack, stroke, or other acute heart or blood vessel event within the past month, or who have poorly controlled heart or blood vessel disease.
• People with significantly reduced heart pumping function, classified as Grade III or IV heart failure, or a heart scan showing reduced heart function below 50%.
• People with high blood pressure that remains difficult to control despite treatment, or who have a history of a hypertensive crisis.
• People with a known risk of gastrointestinal bleeding, including active stomach ulcers, a positive stool blood test at a certain level, or a history of black stools or vomiting blood within the past 2 months.
• People with abnormal blood clotting test results or a tendency to bleed.
• People with wounds or broken bones that have not healed, or who have had major surgery or serious injury within the past 4 weeks.
• People with immune system deficiency conditions (such as HIV), or active hepatitis B or C infection based on blood test results.
• People with a history of substance misuse that cannot be stopped, or people with a diagnosed mental health condition that would affect their ability to take part.
• People with other serious illnesses that, in the doctor's judgement, could affect safety or the ability to complete the study.
• Women who are pregnant, breastfeeding, or of childbearing age and not using adequate contraception.
• People who the study doctor considers unsuitable for any other reason.

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