Hepatocellular Carcinoma, Recurrence
Conditions
Brief 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
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.
Interventions
DRUGThalidomide
Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5 years |
Countries
China
Contacts
Primary ContactYan-Ming Zhou, MD
Outcome results
None listed