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

the First Affiliated Hospital of Henan University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

•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).

发起方

the First Affiliated Hospital of Henan University of TCM