drugset / Trial / NCT02527772
Liposomal Doxorubicin Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine that Liposomal Doxorubicin(LD) plus Gemcitabine(GEM) is superior to Oxaliplatin（OXA） Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.
Timeline
- Start
- 2015-09
- Primary completion
- 2017-09
- Completion
- 2018-09
Outcome
Missed primary endpoint
Stopped: “It doesn't meet the requirements of randomized trials”
paper Although the study did not meet its primary end point, the trend toward improved OS with FOLFOX4 PMID 23980077 ↗
Publications
- Results Lombardi G, Zustovich F, Farinati F, Cillo U, Vitale A, Zanus G, Donach M, Farina M, Zovato S, Pastorelli D. Pegylated liposomal doxorubicin and gemcitabine in patients with advanced hepatocellular carcinoma: results of a phase 2 study. Cancer. 2011 Jan 1;117(1):125-33. doi: 10.1002/cncr.25578. Epub 2010 Aug 31.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |