Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT05466565

Antiviral Therapy for Patients With Liver Cancer After Surgery

Led by Xiangya Hospital of Central South University · Updated on 2022-07-20

360

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Antiviral Therapy for Patients With Liver Cancer After Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years, any gender
  • Patients with hepatocellular carcinoma after radical surgical resection or radiofrequency ablation
  • Positive for hepatitis B surface antigen (HBsAg)
  • No residual tumor on intraoperative pathology and imaging shows complete remission within 4 weeks after surgery
  • Suitable for receiving peginterferon and nucleoside (acid) analog therapy as assessed by investigator
  • Signed informed consent form or consent provided by legal guardian or agent
Not Eligible

You will not qualify if you...

  • Currently receiving hepatotoxic drugs, immunosuppressants, targeted drug therapy, or adjuvant chemotherapy after surgery
  • Past or current other malignant tumors except cured skin basal cell or squamous cell carcinoma and cervical carcinoma in situ
  • Allergy to interferon alpha or its components, or judged unsuitable for interferon alpha use
  • Co-infection with HAV, HCV, HDV, HEV, HIV or other chronic liver diseases including alcoholic liver disease, genetic metabolic liver disease, drug-induced liver disease, non-alcoholic fatty liver disease
  • Autoimmune diseases including autoimmune liver disease and psoriasis
  • Neutrophil count below 1.5 x 10^9 cells/L or platelet count below 80 x 10^9 cells/L
  • Creatinine above 1.5 times the upper normal limit
  • Serious diseases of heart, lung, kidney, brain, blood or other major organs
  • Severe neurological or psychiatric diseases such as epilepsy, depression, mania, seizures, or schizophrenia
  • Unstable diabetes, hypertension, thyroid disease, or history of severe retinopathy
  • Child-Pugh grade C liver function
  • Drug abuse or alcoholism
  • Infection, bleeding, or postoperative complications that make participation unsuitable
  • Evidence of liver cancer recurrence or metastasis at baseline
  • Pregnant or breastfeeding, or planning pregnancy and unwilling to use contraception during the study
  • Investigator assessment that participation is unsuitable
  • Participation in other clinical trials at the same time

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Xiangya Hospital of Central South University

Changsha, Hunan, China, 417100

Actively Recruiting

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Research Team

L

Ledu Zhou, PhD student

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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