Validation study for the scheme of reducing the recurrence rate of hepatitis b-related hepatocellular carcinoma in stage I after comprehensive minimally Invasive surgery with traditional Chinese medicine.
- Conditions
- hepatitis b-related hepatocellular carcinoma in stage I
- Registration Number
- ITMCTR1900002320
- 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
1) Patients who meet the diagnostic criteria of hepatitis B-related hepatocellular carcinoma; 2) Clinical stage I 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, gender unlimited; 5) General condition was good, the Karnofsy score, 1 week before admission to the group, reaches 60 points; 6) Patients diagnosed as Zhengxu and Yuzhi syndrome by TCM; 7) Patients signed an informed consent to participate in the experimental study, and can ensure follow-up.
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).
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver tumor markers;electrocardiogram;liver function;kidney function;blood coagulation;stool routine examination;blood routine;HBV-DNA;routine urine test;T cell subset;imaging examination;
- Secondary Outcome Measures
Name Time Method