Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary enrollment with written informed consent is required; 2.Participants should be aged between 18 and 80 years (inclusive), without regard to gender; 3.Patients should have hepatocellular carcinoma (HCC) that is either clinically diagnosed or histologically/cytologically confirmed in accordance with the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)"; 4.There should be at least one evaluable lesion (as defined by the RECIST 1.1 criteria; 5.Clinically diagnosed portal hypertension with at least one complication of portal hypertension is necessary, including refractory or recurrent esophageal/gastric variceal bleeding, ascites, or hepatic pleural effusion; 6.The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score should range from 0 to 1; 7.Child - Pugh score should be =25 g/L, total bilirubin 30 mL/min. Regarding coagulation function, the international normalized ratio (INR) or prothrombin time (PT) should be <=1.5×ULN, and the activated partial thromboplastin time (APTT) <=1.5×ULN; 9.Female patients of childbearing age and male patients with female partners of childbearing age must employ effective contraception throughout the treatment period and for 6 months after the last dose; 10.Subjects should demonstrate good compliance and cooperate with follow - up procedures.
Exclusion criteria
Exclusion criteria: 1.Previous histopathological or cytological diagnoses indicating the presence of components such as fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma; 2.A history of congenital or acquired immunodeficiency disorders; 3.Prior history of severe psychiatric conditions; the concurrent existence of cancer emboli in the inferior vena cava or right atrium; 4.Thromboembolic events occurring within the past six months (e.g., stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism); 5.Clinically significant cardiovascular diseases, encompassing but not restricted to acute myocardial infarction (AMI), severe or unstable angina, coronary artery bypass grafting (CABG), congestive heart failure (New York Heart Association [NYHA] class > 2), or poorly controlled arrhythmias or the presence of an implantable pacemaker for arrhythmias within the past six months; 6.Other notable clinical or laboratory abnormalities that investigators consider to have an impact on safety evaluation, such as uncontrolled diabetes, chronic kidney disease, peripheral neuropathy of grade II or higher (Common Terminology Criteria for Adverse Events [CTCAE] V5.0), thyroid dysfunction; 7.Active or poorly controlled severe infections; 8.Conditions influencing the absorption, distribution, metabolism, or clearance of study drugs (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, or malabsorption).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate of pleural/ascitic fluid;Overall Rebleeding Rate;Disease control rate;TIPS shunt patency rate;Objective Response Rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactJianjun Li
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed