Phase
Condition
Carcinoma
Liver Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eligible patients were age 18 to 75 years;
The patients had histologically, cytologically,or clinically diagnosed unresectableHCC;and were ineligible for local invasive treatment. Clinically diagnosed patientshad to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoproteinlevels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients hadto have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm oncomputed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesionsthat had undergone previous interventional or local therapy were not consideredmeasurable lesions.
ECOG score≤2;
life expectancy 3 months;
Barcelona Clinic liver cancer (BCLC) stage B or C disease;
Child-Pugh stage A or B disease;
Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, plateletcount≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin
<1.5×ULN, international normalized ratio <1.5;normal baseline left ventricularejection fraction_lower limit of normal for the institution. Patients with AST andALT<5 ×ULN could be recruited if total bilirubin was in the normal range.
- Patients had to provide signed informed consent to participate.
Exclusion
Exclusion Criteria:
documented allergy to lipoidal or other study drugs; any previous treatment beforerandom assignment;
Previous liver transplantation;
concomitant use of any other anticancer therapy, including interferon alfa and herbalmedicine approved by the local authority to be used as anticancer medicine (exceptpalliative radiotherapy to a nontarget lesion);
CNS metastasis;
Other serious illness or medical condition.