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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002319
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis b-related hepatocellular carcinoma in stage II

Interventions

Sponsors

the First Affiliated Hospital of Henan University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Alpha fetoprotein;HBV-DNA;

Countries

China

Contacts

Public ContactMa Suping

the First Affiliated Hospital of Henan University of TCM

masuping@163.com+86 13523526616

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026