NCT02527772

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

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Liposomal Doxorubicin+Gemcitabine	Gemcitabine 1000mg/m2,d1,8,iv; Liposomal Doxorubicin 30mg/m2,d1,iv.q4w of each 28 day cycle. 6 of Cycles: until progression or unacceptable toxicity develops or Progressive Disease.
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-09-01
• Completion: 2018-09-01
• First posted: 2015-08-19
• Last updated: 2019-06-04