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• Status: Withdrawn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.