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The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy


Inclusion Criteria:



- hepatocellular carcinoma

- treated with transcatheter arterial chemoembolization (TACE)

- HBVDNA > 10^3copies/mL, including alanine aminotransferase (ALT) normal patient

- expected survive time > 1 year

- HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)

Exclusion Criteria:

- antiviral therapy history

- alanine aminotransferase (ALT) >400 U/L

- serum total bilirubin > 50 ╬╝mol/L

- HBVDNA > 10^9copies/mL

- extrahepatic metastasis or main portal vein embolus

- apparent cardiac or pulmonary dysfunction

- liver function: Child B or Child C

- HCV infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

jinglin xia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Liver cancer institute, Zhongshan Hospital

Authority:

China: Food and Drug Administration

Study ID:

LCI-001

NCT ID:

NCT01102335

Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatitis B virus
  • Antiviral Agents
  • Liver Neoplasms
  • Drug Toxicity
  • Survival
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Carcinoma, Hepatocellular

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