Primary Hepatocellular Carcinoma
Conditions
Interventions
Experimental Group:Biejia Ruangan compound+Routine Treatment
Control Group:Routine Treatment
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years old (inclusive), regardless of gender. 2.History of HBV infection and first clinical diagnosis of primary hepatocellular carcinoma (HCC). 3.Clinical stage of HCC classified as CNLC stage ?a–?a. 4.Completed radical treatment for HCC. 5.No postoperative surgical complications of Clavien-Dindo grade ? or ?. 6.Pathologically or clinically confirmed diagnosis of hepatocellular carcinoma. 7.Clinically diagnosed with liver fibrosis/cirrhosis, or clinically judged to have a tendency of liver fibrosis. 8.No residual tumor detected by enhanced liver computed tomography (CT) or magnetic resonance imaging (MRI) in the first re-examination within 4 weeks after radical treatment. 9.Liver function classified as Child-Pugh grade A or B, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0–2. 10.Voluntarily enroll in the study, with the ability to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.History of receiving radiotherapy, chemotherapy, molecular targeted therapy, immunotherapy or other anti-tumor treatments prior to surgery. 3.Scheduled to receive treatment with other anti-tumor traditional Chinese medicines, including proprietary Chinese medicines or Chinese herbal medicines. 4.Patients with neuropsychiatric disorders, especially those with a history of mental illnesses such as depression, anxiety, mania, schizophrenia, or a family history of mental illnesses (particularly a family history of depression or depressive tendency). 5.Concurrent active infection with hepatitis A, hepatitis C, hepatitis D, hepatitis E and/or human immunodeficiency virus (HIV). 6.History of renal diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine level > 2.0 × upper limit of normal (ULN) at screening. 7.Patients with autoimmune diseases, including psoriasis, systemic lupus erythematosus, autoimmune liver disease, etc. 8.History of severe heart diseases, especially those with unstable or poorly controlled heart diseases within 6 months. 9.Patients planning to receive organ transplantation or who have already undergone organ transplantation. 10.Patients with a history of allergy to Biejia Ruangan compound Tablets, nucleoside (acid) analogues or pharmaceutical excipients, or those who meet any contraindication specified in the package insert of the investigational medicinal product. 11.Participation in other interventional clinical trials within 1 month prior to screening, or other conditions deemed inappropriate for enrollment by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-Year Recurrence-Free Survival (RFS);Liver Cirrhosis Improvement Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Year Recurrence-Free Survival (RFS);3-Year Recurrence-Free Survival (RFS);5-Year Recurrence-Free Survival (RFS);1-Year Overall Survival (OS);3-Year Overall Survival (OS);5-Year Overall Survival (OS);Hepatic Fibrosis Improvement Rate;Safety evaluation;Every three weeks;Performance Status (PS); | — |
Countries
China
Contacts
Public ContactZhi Yunyang
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed