hepatocellular carcinoma
Conditions
Interventions
Single-dose Administration Group:On Day 1 of the trial, subjects shall have breakfast in the morning and finish the meal within 30 minutes. The drug shall be taken 30 minutes after the meal: 600 mg (6
Single-dose Administration Group:On Day 1 of the trial, subjects shall have breakfast in the morning and finish the meal within 30 minutes. The drug shall be taken 30 minutes after the meal: 900 mg (9
Single-dose Administration Group:On Day 1 of the trial, subjects shall have breakfast in the morning and finish the meal within 30 minutes. The drug shall be taken 30 minutes after the meal: 1200 mg (
Multiple-dose Administration Group:Subjects shall take the drug 30 minutes after breakfast and dinner, and each of these two meals shall be finished within 30 minutes. The drug to be taken is 600 mg (
Sponsors
Jiangsu Provincial People's Hospital
Nanjing Tianyinshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Aged >= 18 years, regardless of gender; 2: Patients with hepatocellular carcinoma (HCC) who strictly meet the clinical diagnostic criteria for HCC specified in the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) issued by the Chinese Society of Clinical Oncology (CSCO), and/or have been diagnosed with HCC via pathological tissue/cytological examination; 3: Patients with unresectable or metastatic hepatocellular carcinoma (HCC); 4: The interval between the first dose of medication and hepatectomy is > 3 months; the interval between the first dose and the end of local ablation, hepatic arterial intervention, or radiotherapy is > 4 weeks (for radioactive seed implantation, the interval needs to be > 3 months); and the recovery of relevant adverse reactions is = 12 weeks; 10: Basic normal function of major organs, meeting the following requirements: 1. Bone marrow: Platelet count >= 60 × 10?/L, hemoglobin >= 85 g/L, white blood cell count >= 3.0 × 10?/L; 2. Liver: Total bilirubin = 28 g/L; 3. Kidney: Serum creatinine = 50 mL/min; 11: HBV-DNA < 104 copies/mL (2000 IU/mL); 12: Women of childbearing age must undergo a pregnancy test within 7 days before the first dose of medication, and the result must be negative; men of childbearing age: effective contraceptive measures must be taken during the trial and within 3 months after the end of the trial; 13: Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 14: No participation in other clinical trials within 4 weeks before signing the informed consent form; if a case fails the screening of other trials but meets the requirements of this trial, it can be enrolled.
Exclusion criteria
Exclusion criteria: 1: Moderate to severe ascites, i.e., a Child-Pugh score of > 2 for this indicator; uncontrolled or moderate to severe pleural effusion, pericardial effusion; 2: Having undergone major surgery (such as craniotomy, thoracotomy, laparotomy, hip replacement surgery, etc.) within 28 days before the first dose of medication; 3: Cholangiocellular carcinoma and fibrolamellar carcinoma; a history of other malignant tumors within the past 5 years or concurrent presence of other malignant tumors, except for carcinoma in situ of the cervix, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis, T1); 4: Pregnant or lactating women; 5: Patients with myocardial ischemia or myocardial infarction of Grade ? or higher according to CTCAE classification, uncontrolled arrhythmia, and/or heart failure of Grade ?-? according to NYHA criteria; 6: Patients who have previously received allogeneic organ transplantation (including liver transplantation) or plan to receive liver transplantation during the trial; 7: Patients who have experienced hepatic encephalopathy and/or hepatic nephropathy within 6 months before signing the informed consent form; 8: Active hepatitis C, i.e., positive anti-HCV or positive HCV-RNA, with ALT and/or AST > 2× ULN; 9: Positive result in human immunodeficiency virus (HIV) test, or presence of severe infection (Grade >= 3 according to NCI-CTCAE classification) at the time of randomization; 10: Inability to swallow, chronic diarrhea, or intestinal obstruction, which significantly affects drug administration and absorption; 11: A history of gastrointestinal bleeding within 6 months before signing the informed consent form, or a clear tendency for gastrointestinal bleeding (e.g., local active ulcer lesions, fecal occult blood >= 2+; persistent positive fecal occult blood requires gastroscopy and/or colonoscopy for investigation); 12: Patients with known or suspected active autoimmune diseases; 13: Known central nervous system (CNS) metastasis; patients with suspected CNS metastasis must undergo cranial MRI examination to rule out the possibility; 14: Significant abnormalities in coagulation function: international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 16 s; 15: A history of schizophrenia or abuse of psychotropic drugs; 16: Known allergy or intolerance to icariin and its excipients; 17: Other conditions that, in the investigator’s judgment, would prevent the patient from participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactYingxia Chen
Nanjing Tianyinshan Hospital
Outcome results
None listed