Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma

August 15, 2013 updated by: The First Affiliated Hospital of Xiamen University

Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma.: a Randomized Controlled Trial

Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective in preventing or delaying recurrence. The aim of this prospective randomized study was to evaluate the effectiveness of Thalidomide as a postoperative adjuvant regimen in inhibiting the recurrence of HCC

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A number of modalities for preventing HCC recurrence after resection have been proposed and analyzed. Both preoperative and adjuvant transcatheter arterial chemoembolization (TACE) were found to be unable to reduce the risk of postoperative recurrence significantly, or confer a survival advantage. Vitamin K (VK) is a fat-soluble vitamin that regulates clotting factor production by acting as a coenzyme for a VK dependent carboxylase that catalyzes carboxylation of glutamic acid residues into gamma-carboxyglutamic acid. The findings in vitro have indicated that VK2 has an antiproliferative effects against hepatoma cell lines, but its efficacy in suppressing HCC recurrence was not confirmed in human studies. Interferon has a variety of biologic properties, including antiviral, immunomodulatory, antiproliferative, antiangiogenic and tumoricidal effects. It is reported that interferon is effective in preventing the development of HCC recurrence after its curative treatment in HCV-related cirrhosis. However, interferon treatment also has side-effects, including flu-like symptoms, fatigue, neutropenia, thrombocytopenia, depression, bone marrow suppression, and unmasking or exacerbation of autoimmune illnesses, which lead either to treatment disruption or dose modification. Polyprenoic acid, an acyclic retinoid, reportedly is effective in prevention of second primary hepatomas, but long-term safety and efficacy data are lacking.

Thalidomide possesses immunomodulatory,anti-inflammatory, and antiangiogenic properties.It has successfully been applied for the treatment of various malignancies including HCC.To investigated whether postoperative adjuvant therapy with Thalidomide could inhibite the recurrence of HCC after radical resection,we planed to conduct this clinical trial.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • Bin Li
        • Principal Investigator:
          • Lu-Peng Wu
        • Principal Investigator:
          • Xiu-Dong Li
        • Principal Investigator:
          • Xu Su

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-75 years old,male and female
  2. Patients who did not receive any anti-tumor therapies prior to the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy) resection of hepatocellular carcinoma
  3. Patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis
  4. Sign the informed consent

Exclusion Criteria:

  1. Women who were pregnant or breast-feeding
  2. signs showing recurrence or metastasis one month after surgery
  3. Recurrent HCC
  4. Patients unable to take drug orally
  5. Patients inappropriate to participate in the trial upon the investigator's judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thalidomide
Thalidomide 100mg per day after the radical resection HCC
Drug: Thalidomide
Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
Other Names:
  • Contergan
Active Comparator: Control
No adjuvant Thalidomide treatment after curative hepatic resection
Drug: Thalidomide
Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
Other Names:
  • Contergan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Yanmng Zhou, MD, Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 21, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAHXMU-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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