Primary liver cancer
Conditions
Interventions
Experimental Group:Biejia-Ruangan compound+Adjuvant treatment after radical treatment
Control group:Adjuvant treatment after radical treatment
Sponsors
Beijing Ditan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (inclusive), regardless of gender; 2. Has a history of HBV infection and was diagnosed with primary liver cancer for the first time; 3. The clinical stage of liver cancer is CNLC stage Ia-IIa; 4. Complete radical surgical resection (pathology confirmed negative resection margin); 5. There were no Clavien-Dindo III and IV surgical complications after operation; 6. Pathologically confirmed hepatocellular carcinoma without large blood vessels and bile duct cancer thrombus, and complicated with hepatitis B-related liver fibrosis; 7. No tumor residue was found on liver enhanced CT or MRI for the first time 4 weeks after operation; 8. Liver function was Child-Pugh A/B, PS 0-2; 9. Volunteer to enroll and be able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Having received chemoradiotherapy and/or anti-tumor therapies such as molecular targeted and immunity before surgery; 3. Will be treated with other anti-tumor traditional Chinese medicines (including proprietary Chinese medicines or Chinese herbal medicines); 4. People with neuropsychiatric diseases, especially those with a history of mental diseases such as depression, anxiety, mania, and schizophrenia or a family history of mental diseases (especially those with a history of depressive diseases or depressive tendencies); 5. Concurrent infection with hepatitis A, hepatitis C, hepatitis D, hepatitis E and/or HIV; 6. Kidney disease: acute and chronic nephritis, renal dysfunction, nephrotic syndrome, etc.; or blood creatinine>2.0×ULN at screening; 7. Autoimmune diseases, including psoriasis, systemic lupus erythematosus, autoimmune liver disease, etc.; 8. Upper gastrointestinal bleeding within 3 months before screening (including screening period); 9. A history of severe heart disease, especially unstable or poorly controlled heart disease within 6 months; 10. Those planning to receive an organ transplant or who have already had an organ transplant; 11. Those who are allergic to Compound Biejia Ruangan Tablets, nucleoside (acid) analogues, or pharmaceutical excipients, or who meet any of the contraindications in the investigational drug instructions; 12. Participated in other interventional trials within 1 month before screening or in other circumstances that the investigator deems inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival (RFS) at two years (96 weeks) after radical surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival (RFS) at 1, 3, and 5 years after radical surgery;Overall survival (OS) at 1, 3, and 5 years after radical surgery;Recurrence-free survival time and overall survival time after radical surgery during the follow-up period;Improvement rate of liver fibrosis and liver cirrhosis (LSM reduction =15% and lasting for more than 6 months): measured by FibroScan®;Blood biochemical indicators: liver function (ALT, AST, TBiL, ALB, GGT, ALP, etc.), renal function (Cr, eGFR, etc.), electrolytes (K, Na, Cl, etc.);Complete Blood Count;Coagulation function: INR, PT;Oncology indicators: AFP, AFP-L3%, abnormal prothrombin (PIVKA-II);Immunological indicators: T cell subsets (CD4T, CD8 T cell counts and proportions), IL-6, TNF- a, IFN- ?;Quality of life score;Imaging indicators: abdominal color ultrasound, abdominal enhanced magnetic resonance imaging; | — |
Countries
China
Contacts
Public ContactZhiyun Yang
Beijing Ditan Hospital Capital Medical University
Outcome results
None listed