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Recruiting Observational

Antiviral Therapy for Patients With Liver Cancer After Surgery

NCT05466565 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2021-12-01
Last updated
2022-07-20

Condition(s) studied

Hepatocellular Carcinoma

Study summary

This is a single-center, prospective, observational, real world study designed to evaluate the effects of peginterferon α-2b(pegabin) combined with nucleoside (acid) analogs (entecavir,ETV tenofovir,TDF tenofovir alafenamide,TAF) on patients after radical surgery for hepatitis B associated hepatocellular carcinoma by collecting data from patients at our hospital

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. Age: 18-65 years old, gender is not limited; 2. Patients with hepatocellular carcinoma after radical surgical resection or radiofrequency ablation; 3. HBsAg positive; 4. Intraoperative pathology showed no residual incision margin, and imaging confirmed as complete remission (CR) within 4 weeks after operation; 5. The investigator evaluates that they can receive peginterferon and nucleoside (acid) analog therapy; 6. Sign the informed consent form and be able to comply with the requirements of the program; if the patient cannot sign the informed consent form, his/her legal guardian or agent must sign it. Exclusion Criteria: * 1\. Are receiving hepatotoxic drugs, immunosuppressants or targeted drug therapy, or receiving adjuvant chemotherapy after surgery; 2. Past or concurrent with other malignant tumors, except for cured skin basal cell or squamous cell carcinoma and cervical carcinoma in situ; 3. Those who are allergic to interferon alpha and its drug components, and those who are judged by the investigator to be unsuitable for the use of interferon alpha; 4. Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug-induced liver disease, non-alcoholic fatty liver disease and other chronic liver diseases; combined with autoimmune diseases, including autoimmune liver disease, Psoriasis, etc.; 5. Neutrophil count \< 1.5 x 109 cells/L or platelet count \< 80 x 109 cells/L; 6. Creatinine is higher than 1.5 times the upper limit of normal; 7. Patients with serious diseases of the heart, lung, kidney, brain, blood and other important organs; 8. Patients with severe neurological and psychiatric diseases (such as epilepsy, depression, mania, seizures, schizophrenia, etc.); 9. Unstable control of diabetes, hypertension, thyroid disease, etc.; history of severe retinopathy or patients with retinopathy shown by other evidence; 10. Child-Pugh is graded C; 11. Drug abuse or alcoholism; 12. Infection, hemorrhage or other postoperative complications deemed unsuitable to participate in the study during the baseline examination; the baseline examination indicates the recurrence and metastasis of liver cancer; 13. Pregnant or breastfeeding women or patients who have a pregnancy plan and are unwilling to contracept during the study period; 14. The investigator believes that the subject's current condition is not suitable for participating in this study; 15. Patients who participate in other clinical research trials at the same time.

Primary outcome measure(s)

  • recurrence-free survival time — 240 weeks
    no new liver cancer

Trial sites (1)

FacilityCityRegionStatus
Xiangya Hospital of Central South University Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05466565 on ClinicalTrials.gov ↗ ← All trials in China