Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma

NCT01924624 | Unknown

• 1 other identifier: FAHXMU-013
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma; Recurrence

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (2)

Thalidomide

EXPERIMENTAL

Thalidomide 100mg per day after the radical resection HCC

Drug: Thalidomide

Control

ACTIVE COMPARATOR

No adjuvant Thalidomide treatment after curative hepatic resection

Drug: Thalidomide

Interventions

Thalidomide DRUG

Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period

Also known as: Contergan

Control; Thalidomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,male and female
• 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
• 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
• Sign the informed consent

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

First affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yanmng Zhou, MD

  Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan-Ming Zhou, MD

CONTACT

8605932139708; zhouymsxy@sina.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2013
• First Posted: August 16, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2019
• Last Updated: August 16, 2013

Record last verified: 2013-07

Locations

CN (1)