A Trial of Licartin for Preventing Tumor Recurrence After Liver Resection
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|ClinicalTrials.gov Identifier: NCT00819650|
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Licartin (generic name,[131I]metuximab injection)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Eastern Hepatobiliary Surgical Hospital|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
patients who receive Licartin therapy after liver resection
Drug: Licartin (generic name,[131I]metuximab injection)
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 Name: no adjuvant therapy after liver resection
No Intervention: placebo
control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group with patients who receive Licartin therapy after liver resection
- Overall survival [ Time Frame: 2010 ]
- Time to recurrence [ Time Frame: 2010 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819650
|Eastern hepatobilliary surgery hospital|
|Shanghai, Shanghai, China, 200438|
|Study Chair:||Feng Shen, MD||Eastern hepatobilliary surgery hospital|