Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma
Information source: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma; Recurrence
Intervention: Thalidomide (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The First Affiliated Hospital of Xiamen University Official(s) and/or principal investigator(s): Yanmng Zhou, MD, Principal Investigator, Affiliation: Xiamen University
Overall contact: Yan-Ming Zhou, MD, Phone: 8605932139708, Ext: 8605922139908, Email: zhouymsxy@sina.cn
Summary
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
Clinical Details
Official title: Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma.: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: disease-free survival
Secondary outcome: Overall survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Yan-Ming Zhou, MD, Phone: 8605932139708, Ext: 8605922139908, Email: zhouymsxy@sina.cn
First affiliated Hospital of Xiamen University, Xiamen, Fujian 361003, China; Recruiting Yan-Ming Zhou, MD, Email: zhouymsxy@sina.cn Bin Li, Principal Investigator Lu-Peng Wu, Principal Investigator Xiu-Dong Li, Principal Investigator Xu Su, Principal Investigator
Additional Information
Starting date: July 2013
Last updated: August 15, 2013
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