Know Cancer

or
forgot password

A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-Virus Therapy for the Unresectable Hepatitis B Virus-Related Primary Liver Cancer


N/A
18 Years
70 Years
Open (Enrolling)
Both
Primary Liver Cancer

Thank you

Trial Information

A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-Virus Therapy for the Unresectable Hepatitis B Virus-Related Primary Liver Cancer


primary liver cancer(PLC)is one of the world's most common malignancies, especially in
East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC
cases in China. PLC can develop during any stage of the natural course of chronic HBV
infection and anti-virus therapy should be considered during the management of PLC. However,
there is no definite guide on when or how to practice the anti-virus therapy, especially in
unresectable or inoperable PLC. Because of these facts, research on the significant of the
anti-virus therapy in the HBV-related PLC is urgently needed.

200 patients will be randomly assigned to anti-virus therapy group and control gruop.The
time to progression(TTP) and overall survival within two years will be used to evaluate the
effect of anti-virus therapy on PLC.

The aim of this study is to research the efficacy and significant of the anti-virus therapy
in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus
therapy in PLC.


Inclusion Criteria:



1. Identify patients with PLC in accordance with the clinical diagnostic criteria of
PLC.Patients with PLC shall be diagnosed with or without pathology. It is not
appropriate to perform liver resection operation.

2. serum positive HBsAg≥6 months.

3. Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the
upper limit of normal value, alanine aminotransferase and aspartate aminotransferase
≤ 10 times the upper limit of normal value.

4. hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value.

5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and
lung function are basically normal.

6. Patients who can understand this trial, male or female, aged 18-70 voluntarily
participate in clinical trials and have signed information consent.

Exclusion Criteria:

1. Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may
affect the treatment of liver cancer.

2. Patients with other diseases which may affect the treatment mentioned here.

3. Patients with medical history of other malignant tumors.

4. Subjects participating in other clinical trials.

5. Women in pregnancy and breast-feeding.

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:

time-to-progression(TTP)

Outcome Time Frame:

1,2 and 3 years

Safety Issue:

No

Principal Investigator

Shen Feng, M.D

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2008-005

NCT ID:

NCT00824707

Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Primary Liver Cancer
  • primary liver cancer
  • hepatitis B virus
  • anti-virus therapy
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Liver Neoplasms

Name

Location