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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02534337
• Other study ID #: GE-FOX4/HCC
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: June 2019
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

References & Publications (3)

Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taïeb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. — View Citation

Qin S, Bai Y, Lim HY, Thongprasert S, Chao Y, Fan J, Yang TS, Bhudhisawasdi V, Kang WK, Zhou Y, Lee JH, Sun Y. Randomized, multicenter, open-label study of oxaliplatin plus fluorouracil/leucovorin versus doxorubicin as palliative chemotherapy in patients with advanced hepatocellular carcinoma from Asia. J Clin Oncol. 2013 Oct 1;31(28):3501-8. doi: 10.1200/JCO.2012.44.5643. Epub 2013 Aug 26. — View Citation

Taïeb J, Bonyhay L, Golli L, Ducreux M, Boleslawski E, Tigaud JM, de Baere T, Mansourbakht T, Delgado MA, Hannoun L, Poynard T, Boige V. Gemcitabine plus oxaliplatin for patients with advanced hepatocellular carcinoma using two different schedules. Cancer. 2003 Dec 15;98(12):2664-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival		3 months
Secondary	Objective response rate		3 months
Secondary	Overall survival		6 months and 12 months
Secondary	Disease control rate		3 months
Secondary	Time-to-Progression		3 months