Phase 1 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 75 years old (inclusive)
• People who have been diagnosed with primary or metastatic liver cancer, confirmed by a tissue or cell sample
• People whose liver cancer has not responded to standard treatment, or for whom standard treatment is not suitable, or who have chosen not to receive standard treatment
• People who are in good enough physical condition to carry out normal daily activities, with only minor limitations at most (measured by a standard performance scale called ECOG, scoring 0 or 1)
• People whose liver is functioning at a level rated as Grade A or Grade B on a standard liver function scale called Child-Pugh
• People whose bone marrow, liver, kidneys, and other organs are functioning well enough to meet specific blood test requirements taken within 7 days before starting the trial (without having received blood transfusions or certain blood-stimulating medications in the 14 days before those tests)
• People with chronic hepatitis B who have a viral load below a certain level, and who are receiving appropriate antiviral treatment as required by hepatitis B treatment guidelines
• People with hepatitis C who are receiving appropriate antiviral treatment as required by hepatitis C treatment guidelines, and whose liver function is within the normal range
• People who have recovered from side effects of previous cancer treatments to a mild or absent level (with the exception of hair loss and minor lab abnormalities that cause no symptoms)
• People who have completed treatment for herpes at least 3 months before joining the trial
• People with an expected survival of at least 12 weeks
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose; all people of reproductive potential must agree to use effective contraception during the trial and for 90 days after the last dose
• People who have finished previous cancer treatments (such as hormone therapy, chemotherapy, radiotherapy, or targeted therapy) at least 4 weeks before starting the trial (or at least 6 weeks for certain specific chemotherapy drugs)
• People who have had major surgery at least 4 weeks before starting the trial
• People who have at least one tumour that can be measured or assessed using standard imaging criteria (called RECIST 1.1)

Who may not be able to join:

• People who have had moderate to severe fluid build-up in the abdomen, bleeding from varicose veins in the oesophagus, confusion caused by liver failure, or significant liver insufficiency within the past 6 months
• People whose tumour takes up more than 50% of the liver's volume, or whose tumour is growing into a major blood vessel called the inferior vena cava
• People who have not yet recovered from side effects of previous cancer treatments (beyond mild or absent levels, excluding hair loss and minor symptom-free lab changes) before starting the trial
• People who have had another type of cancer in the past 5 years, except for certain well-controlled skin cancers or cervical pre-cancer that has been effectively treated
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord, regardless of their current condition; people with cancer spread to the brain may be considered in certain stable circumstances (confirm with trial site)
• People who have received standard liver cancer treatments — including surgery, interventional procedures, systemic therapy, radiotherapy, or certain traditional Chinese medicine therapies with anti-tumour indications — within 4 weeks before starting the trial (a shorter one-week washout may apply for certain traditional Chinese medicine therapies — confirm with trial site)
• People who have received intensive radiotherapy involving a large area of bone marrow within 4 weeks before starting the trial
• People who have previously received treatments that are similar in type to the drug being studied in this trial
• People who have had major surgery, or who have wounds, ulcers, or fractures that have not healed, within 4 weeks before starting the trial
• People who currently have active stomach or bowel ulcers, ulcerative colitis, or other digestive tract conditions, or who have active bleeding from a tumour, or other conditions the treating doctor believes could lead to digestive tract bleeding or perforation
• People who have had significant bleeding episodes within the past 2 months, coughed up fresh blood within the past 4 weeks, or had a stroke or blood clot event within the past 12 months
• People who have had a significant heart condition within the past 6 months, including heart attack, severe chest pain, or heart bypass surgery; or who have moderate to severe heart failure; or whose heart is not pumping efficiently enough; or who have certain heart rhythm abnormalities
• People with severe abnormalities in their body's electrolyte (mineral) levels that cannot be corrected
• People who have an active infection, or who had an unexplained fever above 38.5°C during the screening period or before starting the trial
• People who are preparing for, or have previously had, an organ or bone marrow transplant, including a liver transplant
• People with a history of lung scarring, lung inflammation, dust-related lung disease, radiation-related lung damage, or drug-related lung problems, or severely reduced lung function
• People with active tuberculosis currently being treated, or treated within the past year; people known to be living with HIV; or people with active hepatitis B or hepatitis C viral activity
• Women who are pregnant or currently breastfeeding
• People known to be allergic to any component of the trial drug (OH2 injection) or any herpes virus-related ingredients
• People with other significant medical conditions — such as uncontrolled diabetes, thyroid problems, epilepsy requiring treatment, or other serious abnormalities — that the treating doctor believes could make the trial unsafe or affect the results
• People who have taken part in another clinical trial using an unapproved or unmarketed experimental drug within 4 weeks before starting this trial
• People who, in the opinion of the treating doctor, have any other factors that could lead to the trial needing to be stopped early for that person

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