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Eastern Hepatobiliary Surgical Hospital

Phase 2
18 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Eastern Hepatobiliary Surgical Hospital

Hepatocellular carcinoma (HCC) represents a major health care challenge in the present era,
with its incidence rate of 71128 cases and the mortality rate of 679871 cases during 2007 in
the world. Although liver transplantation, resection and locally ablative therapies remain
useful treatment preference in patients with early HCC, but they often cannot be availed
because of either disease progression or outgrowth of treatment criteria, especially for
liver resection. Moreover, after resection, recurrence of liver tumor can be expected in as
many as 70% of patients within 5 years which leading to the unsatisfactory long term
survival of patients with HCC, hence prevention and effective management of recurrence are
undoubtedly the major strategies to prolong the survival. And until now although a lot of
different adjuvant therapies had been tried in the clinic, including TACE, immunotherapy and
antivirus therapy etc. their role in preventing recurrence remain controversial.

Licartin (generic name, [131I]metuximab injection), a member of CD147 family and a
therapeutical anti-HCC radioimmunologic agent, generated by labeling of 131I with murine
monoclonal antibody (mAb) target fragment HAb18 F(ab_)2, was approved as a new drug for
clinical therapy of primary HCC by China State Food and Drug Administration for its good
concentrate in the tumor region and safe and effective treatment of HCC. Previous RCT study
indicated that Licartin prevented post-Orthotopic liver transplantation(OLT) tumor
recurrence in advanced HCC patients exceed Milan criteria. The recurrence rate significantly
decreasing by 30.4% at 1-year follow up in the OLT group compared with those in the control
group showed that Licartin may be a promising drug for preventing tumor recurrence after
liver transplantation. But less information is known about its role as an adjuvant
therapeutic drug after liver resection. To determine the clinical efficacy of Licartin for
preventing tumor recurrence after liver resection, we set up a randomized, controlled trial
in patients who were definitely diagnosed with HCC and who were successfully treated with
liver resection.

Patients with HCC who received curative liver resection (R0)and with positive expression of
HAb18G/CD147 in the HCC tissues were randomly assigned 1:1 by the doctors to receive
placebo(control group) or Licartin (treatment group). All patients in the treatment group
received Licartin 3 times at an interval of 28 days beginning from the 4th week after liver
resection. The outcomes of patients were evaluated during the 3-years follow up.

Inclusion Criteria:

1. Patients with HCC who received curative liver resection (R0)and with positive
expression of HAb18G/CD147 in the HCC tissues

2. Karnofsky Performance Score performance over 60

3. The functions of the kidney, heart and lung and the blood system are normal and
fittable for Licardin therapy.

4. The liver function is of grade A or B in Child-Pugh classification.

5. Patients give consent to the test.

Exclusion Criteria:

1. Negative expression of HAb18G/CD147 in the HCC tissues

2. Allergic history to biologic products(Licartin)

3. Any of the situation list below: WBC less than 2000/ml, Hb less than 90g/L or PLT
less than 50000/ml, bilirubin level more than 2.5 times the upper limit of normal
value, serum albumin less than 32 g/l.

4. Severed disease of the heart, lung, kidney, brain and blood system.

5. Other severed disease might affect the trial .

6. 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: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

Feng Shen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern hepatobilliary surgery hospital


China: Ministry of Health

Study ID:




Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • adjuvant therapy
  • Licartin
  • time to recurrence
  • overall survival
  • Carcinoma
  • Recurrence
  • Carcinoma, Hepatocellular