Overview

Gemcitabine Plus Oxaliplatin Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma

Status:
Withdrawn
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine that Gemcitabine(GEM) plus oxaliplatin(OXA) (GEMOX) is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging progression-free survival(PFS) in patients with Advanced Hepatocellular Carcinoma.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guangxi Medical University
Treatments:
Fluorouracil
Gemcitabine
Leucovorin
Oxaliplatin
Criteria
Inclusion Criteria:

- Eligible patients were age 18 to 75 years;

- The patients had histologically, cytologically,or clinically diagnosed unresectable
HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients
had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein
levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had
to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on
computed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesions
that had undergone previous interventional or local therapy were not considered
measurable 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, platelet
count≥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 ventricular ejection
fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN
could be recruited if total bilirubin was in the normal range.

- Patients had to provide signed informed consent to participate.

Exclusion Criteria:

- documented allergy to platinum compounds or other study drugs; any previous OXA or GEM
treatment, except adjuvant treatment ﹥12 months before random assignment;

- Previous liver transplantation;

- concomitant use of any other anticancer therapy, including interferon alfa and herbal
medicine approved by the local authority to be used as anticancer medicine (except
palliative radiotherapy to a nontarget lesion);

- CNS metastasis;

- Other serious illness or medical condition.