Status and phase
Conditions
Treatments
About
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
Sex
Ages
Volunteers
Inclusion criteria
Signed written informed consent.
Diagnosis of HCC by:
Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by:
A new hepatic defect on imaging with an AFP > 1000 ng/ml, or
A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present:
HCC must be unresectable and non-transplantable.
Hematocrit > 30%, platelet count >= 50,000 per microliter, WBC > 2.0 x 109/L, and polymorphonuclear white cell count >= 1.0 x 109/L.
Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/dl.
If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal