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A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure

35 Years
55 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad,
still shows a rising trend. Postoperative hepatic failure remains a major reason of liver
resection's failure.

• As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect
of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it
restrain inflammatory mediator to release. But it's lack of clinical evidence that
Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The
purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in
patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to
evaluate that Ulinastatin can improve survival in HCC patients or not.

Inclusion Criteria:

1. Male or female patients > 35 years and <=55 years of age.

2. confirmed case (patients with HCC)

3. Tumors can be radical removed and resection volume was 50% to 70%.

4. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper
limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2
times the upper limit of normal value.

5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and
lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥
80.000 cells/mm³.

6. Karnofsky Performance Score performance over 60.

7. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

1. Patients who have undergone previous treatment by Ulinastatin.

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

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

4. Patients with medical history of other malignant tumors.

5. Subjects participating in other clinical trials.

6. Extrahepatic metastasis, portal vein or other major vascular involvement. liver
function: Child B C.

7. Patients would not sign the consent to the trial.

Type of Study:


Study Design:

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

Outcome Measure:

the overall survival rate of each group

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Li Aijun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University


China: Ministry of Health

Study ID:




Start Date:

May 2012

Completion Date:

April 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Ulinastatin
  • Hepatic Failure
  • Carcinoma
  • Liver Failure
  • Carcinoma, Hepatocellular