hepatocellular carcinoma
Conditions
Interventions
Treatment Group:Sanshimao formula + Conventional treatment
Control Group:Conventional treatment
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years old. 2. Confirmed as HCC histologically or clinically (in accordance with the standards of the "Diagnosis and Treatment Guidelines for Primary Liver Cancer" in China), with BCLC staging at A or B stage. Diagnostic criteria: Clinical diagnostic standards from the "Diagnosis and Treatment Guidelines for Primary Liver Cancer 2019 Edition" issued by the National Health Commission are adopted. Clinical diagnosis of HCC can be established when the following conditions are met: a. Evidence of liver cirrhosis and HBV and/or HCV infection (positive HBV and/or HCV antigens). b. Typical imaging features of HCC: Concurrent multi-row CT scans and/or dynamic contrast-enhanced MRI show rapid heterogeneous vascular enhancement in the arterial phase and rapid washout in the venous or delayed phase for liver lesions. 1) If the liver lesion diameter is =2 cm, HCC can be diagnosed if one of the imaging examinations (CT or MRI) shows the aforementioned HCC features. 2) If the liver lesion diameter is 1-2 cm, both CT and MRI must show the aforementioned HCC features to diagnose HCC, enhancing diagnostic specificity. c. Serum AFP =400 µg/L for at least 1 month, or =200 µg/L for at least 2 months, with exclusion of other causes of AFP elevation, including pregnancy, germ cell tumors, active liver disease, and secondary liver cancer. 3. Meets the diagnostic criteria for liver fibrosis by the Hepatology Branch of the Chinese Medical Association, with Child-Pugh liver function classification at A or B stage. 4. Has undergone liver resection or local therapy (ablation, TACE, etc.) and achieved complete radiological response (RECIST 1.1). 5. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Age 85 years. 2. Concomitant active malignant tumors. 3. Allergic constitution or known allergy to components of the traditional Chinese medicine used. 4. Participation in other drug clinical trials within the past 6 months prior to study enrollment. 5. Pregnant or breastfeeding women. 6. Subjects deemed by the investigator to have poor compliance or incomplete data that may affect the assessment of efficacy or safety. 7. Subjects who have undergone solid organ transplantation. 8. Subjects with a history of brain metastasis, leptomeningeal lesions, or uncontrolled spinal cord compression. 9. Subjects who experienced esophageal or gastric variceal bleeding within the past 6 months prior to enrollment. 10. Other conditions deemed by the investigator to potentially affect the conduct of the clinical study or the evaluation of study results.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Liver stiffness measurement;laminin-5;Collagen Type IV;hyaluronic acid;procollagen type III; | — |
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival;Recurrence rate; | — |
Countries
China
Contacts
Public ContactJuan Du
Shanghai Changhai Hospital
Outcome results
None listed