Phase 2 Hypertension 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 have voluntarily agreed to take part and have signed a consent form
• People aged 18 to 75 years old, of any gender
• People who have been confirmed by pathology (laboratory testing of tissue) to have hepatocellular carcinoma (a type of liver cancer), with at least one area of cancer that has not yet been treated locally and can be measured on scans
• People whose general health and ability to carry out daily activities is rated at a level of 0 or 1 on a standard medical scale (meaning fully active or restricted only in physically strenuous activity)
• People whose liver cancer is at an advanced stage (BCLC-C) and who also have high blood pressure in the portal vein (the main vein supplying the liver) caused by a tumour clot
• People who are newly diagnosed and have not received any previous local or systemic treatment for this cancer
• People whose doctors estimate they are likely to live for at least 3 more months
• People whose blood and organ test results meet specific minimum levels, including adequate white blood cell, platelet, and red blood cell counts, as well as acceptable liver, kidney, and thyroid function results (confirm specific values with trial site)
• People with a liver function score (Child-Pugh score) of 13 points or fewer
• People who have been diagnosed with at least one complication related to portal hypertension, such as gastrointestinal bleeding, ascites (fluid build-up in the abdomen) that keeps coming back or is hard to control, fluid around the lungs, or a tumour clot that blocks more than half of the portal vein
• People of childbearing age who agree to use an approved form of contraception during the study and for 3 months after treatment ends, and who test negative for pregnancy within 72 hours before joining; people who are breastfeeding are not eligible
• Male participants whose partners could become pregnant must agree to use effective contraception during the study and for 3 months after treatment ends

Who may not be able to join:

• People who have an active autoimmune disease or a history of autoimmune disease (a condition where the immune system attacks the body's own tissues)
• People who are currently using medicines that suppress the immune system, including steroid tablets at doses above a certain level, within 2 weeks before joining (confirm with trial site)
• People who have had a severe allergic reaction to any ingredient in the study drug (donafenib tablets) or to iodine-based contrast dyes used in scans
• People who have cancer that has spread to the brain or spinal cord
• People who have previously had a liver transplant
• People whose tumour clot extends beyond the portal vein into other blood vessels, such as the hepatic vein, inferior vena cava, right side of the heart, splenic vein, or superior mesenteric vein
• People with high blood pressure that cannot be adequately controlled with medication (systolic pressure 140 mmHg or higher, or diastolic pressure 90 mmHg or higher)
• People with serious or uncontrolled heart conditions, such as moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, certain abnormal heart rhythms, or abnormal heart electrical readings beyond set thresholds (confirm specific values with trial site)
• People with blood clotting problems, a tendency to bleed, or who are receiving clot-dissolving or blood-thinning treatments (low-dose aspirin and low-molecular-weight heparin used for prevention may be acceptable — confirm with trial site)
• People with a Child-Pugh liver function score above 13 points
• People who have had a stroke, mini-stroke, brain bleed, deep vein clot, or a blood clot in the lungs within the 6 months before joining the trial
• People with a known inherited or acquired tendency to bleed or form clots, such as haemophilia or low platelet levels
• People whose urine tests show a significant level of protein and whose 24-hour urine protein is confirmed to be above 1.0 g
• People who have an active infection, an unexplained fever of 38.5°C or higher in the 7 days before starting treatment, or an abnormally high white blood cell count at the start of the trial
• People with a known immune deficiency condition, such as HIV infection
• People with moderate-to-severe high blood pressure in the lungs (pulmonary hypertension), with pulmonary artery pressure above 40 mmHg on ultrasound
• People who have had or currently have another type of cancer in the past 3 years, with the exception of certain fully treated skin cancers or early-stage cervical cancer
• People who have previously received anti-PD-1 or anti-PD-L1 immunotherapy, or who have previously been treated with apatinib
• People who, in the investigator's judgement, have other conditions or circumstances that could affect the study results or their safety, such as serious ongoing illness, mental health conditions requiring treatment, alcohol or drug misuse, or other significant health concerns

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