The clinical trial scheme of TCM in improving the clinical benefit rate of stage II HBV-associated hepatocellular carcinoma after combined minimally invasive surgery

Not Applicable

Conditions: hepatitis b-related hepatocellular carcinoma in stage II

Registration Number: ITMCTR1900002319

Lead Sponsor: the First Affiliated Hospital of Henan University of TCM

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. patients who meet the above criteria for diagnosis of HBV-related hepatocellular carcinoma;
2. clinical stage II of primary hepatocellular carcinoma;
3. administrated with comprehensive minimally invasive treatment witin 2 months. Images confirmed that there were no active lesions (up to CR) or measurable active lesions in vivo, which decreased by more than 80% compared with the original lesions (i.e., those with partial residual activity after comprehensive treatment, but could not be treated with minimally invasive treatment because of their special location). Child-Pugh grading A/B of liver function;
4. aged 18-75 years old male and female;
5. good general condition, Karnofsy score 60 within 1 week before enrollment;
6. syndrome differentiation in traditional Chinese medicine is the syndrome of deficiency and stasis;
7. the patient signed an informed consent to participate in the experimental study and was guaranteed to be followed up.

Exclusion Criteria

1. In the past (within 5 years) or with other incurable malignant tumors at the same time;
2. aminotransferase (AST or ALT) > 5 times normal value and/or total bilirubin significantly increased > 3 times normal value;
3. patients with severe infection, fever, hemorrhagic tendency, refractory peritoneal effusion and stage III, IV hepatic encephalopathy;
4. severe heart, lung and kidney diseases, cerebral hemorrhage. Patients with accidental or severe diabetic complications;
5. pregnant or lactating women; patients with mental disorders;
6. allergic constitutions or known allergies to the components of the drug;
7. those who are participating in clinical trials of other drugs or receiving treatment with other traditional Chinese medicines;
8. Researchers believe that other causes are not suitable for clinical trials (e.g., combined with active alcoholic cirrhosis or autoimmune liver disease).