Hepatocellular Carcinoma
Conditions
Interventions
Observation group:None
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–80 years, regardless of sex; 2.Hepatocellular carcinoma (HCC) confirmed by imaging and/or histopathology; 3.Undergone TIPS procedure with imaging and/or Doppler ultrasound confirmation of stent patency; 4.Child-Pugh class A or B; 5.Planned to receive donafenib treatment, with signed informed consent; 6.Willingness to comply with blood sampling, Doppler ultrasound examinations, and follow-up visits;
Exclusion criteria
Exclusion criteria: 1.Baseline laboratory abnormalities: Albumin 3 × upper limit of normal (ULN); Aspartate aminotransferase (AST) > 5 × ULN; Alanine aminotransferase (ALT) > 5 × ULN; Alkaline phosphatase (ALP) > 5 × ULN; Creatinine > 1.5 × ULN or creatinine clearance 1.5 × ULN; activated partial thromboplastin time (APTT) > 1.5 × ULN; 2.Presence of active hepatic encephalopathy or refractory ascites; 3.Unstable acute complications within 4 weeks post-TIPS (e.g., stent dysfunction, active bleeding, severe infection); 4.Known hypersensitivity to donafenib or any of its excipients; 5.Uncontrolled severe cardiovascular events (e.g., myocardial infarction within the past 6 months, decompensated heart failure); 6.Central nervous system metastases requiring urgent intervention; 7.Concomitant use of medications with significant drug–drug interactions that cannot be adjusted (e.g., strong CYP3A inducers or inhibitors); 8.Pregnancy or lactation; 9.Any other condition deemed unsuitable for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood drug concentration; | — |
Countries
China
Contacts
Public ContactMin Jia
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed