A Trial of Licartin for Preventing Tumor Recurrence After Liver Resection
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to analyze the therapeutic effect of adjuvant Licartin therapy after
      resection.Patients receiving curative resection (R0) were randomized to postoperative
      Licartin group and no Licartin group. The time to recurrence ,the overall survival as well as
      the incidence of complications after therapy was observed to confirm the role of adjuvant
      therapy of Licartin.
    

Detailed description: 
      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.
    

Intervention name(s): Licartin (generic name,[131I]metuximab injection)
Intervention type(s): Drug
Intervention description(s): Licartin, radioiodination of Metuximab with Na[131I],with radiochemical purity above 95% and specific activity between 173.25-288.75 MBq/ml.All patients in the treatment group received Licartin 3 times at an interval of 28 days beginning from the 4th week after liver resection
Other intervention name(s): no adjuvant therapy after liver resection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; adjuvant therapy; Licartin; time to recurrence; overall survival