Clinical trial NCT02534337: Gemcitabine Plus Oxaliplatin Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma
Official title: Gemcitabine Plus Oxaliplatin (GEMOX) Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free-Survival
timeFrame: 3 months
Secondary outcomes:
measure: Objective response rate
timeFrame: 3 months
measure: Overall survival
timeFrame: 6 months and 12 months
measure: Disease control rate
timeFrame: 3 months
measure: Time-to-Progression
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Chengcheng Liao, Affiliated Tumor Hospital, Guangxi Medical
name: Lequn Li, PhD
role: STUDY_DIRECTOR
References:
citation: Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb 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. doi: 10.1002/cncr.22532.
citation: Taieb 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. doi: 10.1002/cncr.11869.
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.