drugset / Trial / NCT00921531

Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

NCT00921531

Phase 3 Unknown 200 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-06
Primary completion
2012-12
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Thalidomide Other / unclassified 400 mg
Background MMC Unknown 10 mg
Background OXP Unknown 150 mg
Background fluorouracil Small molecule 1 g