Full Text View
Tabular View
No Study Results Posted
Related Studies
A Trial of Licartin for Preventing Tumor Recurrence After Liver Resection
This study is ongoing, but not recruiting participants.
Study NCT00819650   Information provided by Eastern Hepatobiliary Surgery Hospital
First Received: January 1, 2009   Last Updated: February 3, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

January 1, 2009
February 3, 2009
December 2008
Overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819650 on ClinicalTrials.gov Archive Site
Time to recurrence [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Same as current
 
A Trial of Licartin for Preventing Tumor Recurrence After Liver Resection
Eastern Hepatobiliary Surgical Hospital

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.

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.

Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Hepatocellular Carcinoma
Drug: Licartin (generic name,[131I]metuximab injection)
  • Experimental: patients who receive Licartin therapy after liver resection
  • No Intervention: 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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
December 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
 
China
 
 
NCT00819650
ShenFeng, Eastern Hepatobiliary Surgery Hospital
 
Eastern Hepatobiliary Surgery Hospital
 
Study Chair: Feng Shen, MD Eastern hepatobilliary surgery hospital
Eastern Hepatobiliary Surgery Hospital
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.