LD-FOX4/HCC: Liposomal Doxorubicin Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Liposomal Doxorubicin+Gemcitabine Gemcitabine 1000mg/m2,d1,8;Liposomal Doxorubicin 30mg/m2,d1.q4w |
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.
Other Names:
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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, once every 2 weeks |
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:
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Outcome Measures
Primary Outcome Measures
- Progression-Free-Survival [6 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
Inclusion Criteria:
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Eligible patients were age 18 to 75 years;
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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.
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ECOG score≤2;
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life expectancy 3 months;
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Barcelona Clinic liver cancer (BCLC) stage B or C disease;
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Child-Pugh stage A or B disease;
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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.
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Patients had to provide signed informed consent to participate.
Exclusion Criteria:
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documented allergy to platinum compounds or other study drugs; any previous OXA or DOX treatment, except adjuvant treatment ﹥12 months before random assignment;
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Previous liver transplantation;
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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);
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CNS metastasis;
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Other serious illness or medical condition.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guangxi Medical University
Investigators
- Study Director: lequn Li, MD, GXMU
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LD-FOX4/HCC