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

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: FOLFOX4; Drug: GEMOX

• Registration Number: NCT02534337
• Lead Sponsor: Guangxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-27
• Study Start: 2015-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFOX4	FOLFOX4	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.
GEMOX	GEMOX	gemcitabine 1000 mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2.

Primary Outcome Measures

Name	Time	Method
Progression-Free-Survival	3 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	6 months and 12 months
Objective response rate	3 months
Time-to-Progression	3 months
Disease control rate	3 months