Title
Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
Phase
Phase 3Lead Sponsor
TTY BiopharmStudy Type
InterventionalStatus
TerminatedIndication/Condition
Carcinoma, HepatocellularIntervention/Treatment
thalidomide ...Study Participants
230To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
Inclusion Criteria: Patients with measurable, metastatic or locally advanced hepatocellular carcinoma The diagnosis of HCC should be established either by cyto/histology Patients must be > 20 years of age. ECOG score < 2. Signed informed consent. Female patients at child-bearing age must have negative pregnancy test. Exclusion Criteria: Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible. Patients with advanced second primary malignancy are not eligible. Patients with active infection are not eligible. Patients with pregnancy or breast-feeding are not eligible. Patients with brain metastases are not eligible.