A Trial of Licartin for Preventing Tumor Recurrence After Liver Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00819650
First received: January 1, 2009
Last updated: February 3, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Licartin (generic name,[131I]metuximab injection)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eastern Hepatobiliary Surgical Hospital

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Licartin
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00819650

Locations
China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Feng Shen, MD Eastern hepatobilliary surgery hospital
  More Information

No publications provided

Responsible Party: ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00819650     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-014-1
Study First Received: January 1, 2009
Last Updated: February 3, 2009
Health Authority: China: Ministry of Health
United States: Institutional Review Board

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
adjuvant therapy
Licartin
time to recurrence
overall survival

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2014