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

NCT02534337 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2019-06-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GEMOX

gemcitabine 1000mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2. The treatment was repeated every 2 weeks until disease progression or limiting toxicity.

DRUG

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, once every 2 weeks until progression or unacceptable toxicity develops or Progressive Disease.

Sponsors & Collaborators

  • Guangxi Medical University

    lead OTHER

Principal Investigators

  • Lequn Li, PhD · Chengcheng Liao, Affiliated Tumor Hospital, Guangxi Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02534337 on ClinicalTrials.gov