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

Guangxi Medical University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: FOLFOX4; Drug: GEMOX

Study type: Interventional

Funder types: Other

Identifiers

NCT02534337

GE-FOX4/HCC

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

GEMOX

Experimental group

Description:

gemcitabine 1000 mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2.

Treatment:

Drug: GEMOX

FOLFOX4

Active Comparator group

Description:

Oxaliplatin 85 mg/m2 intravenously on day 1; Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2 over 22 hours on days 1 and 2.

Treatment:

Drug: FOLFOX4