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Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

NCT00921531 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-04-19

No results posted yet for this study

Summary

Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.

Conditions

Interventions

DRUG

Thalidomide

Thalidomide is used for adjuvant therapy for TACE Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day.

DRUG

TACE

TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00921531 on ClinicalTrials.gov