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

Sponsor

Guangxi Medical University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02534337

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: GEMOX Drug: FOLFOX4	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Gemcitabine Plus Oxaliplatin (GEMOX) Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GEMOX gemcitabine 1000 mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2.	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. Other Names: Gemcitabine plus oxaliplatin
Active Comparator: 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.	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. Other Names: Oxaliplatin plus Fluorouracil/Leucovorin

Arm

Intervention/Treatment

Experimental: GEMOX

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

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.

Other Names:

Gemcitabine plus oxaliplatin

Active Comparator: FOLFOX4

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.

Other Names:

Oxaliplatin plus Fluorouracil/Leucovorin

Outcome Measures

Primary Outcome Measures

Progression-Free-Survival [3 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.