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Trial record 40 of 2158 for:    doxorubicin

Liposomal Doxorubicin Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma (LD-FOX4/HCC)

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ClinicalTrials.gov Identifier: NCT02527772
Recruitment Status : Withdrawn (It doesn't meet the requirements of randomized trials)
First Posted : August 19, 2015
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Chengcheng Liao, Guangxi Medical University

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
Hepatocellular Carcinoma Drug: Liposomal Doxorubicin+Gemcitabine Drug: FOLFOX4 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liposomal Doxorubicin(LD) Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2018


Arm Intervention/treatment
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 Name: Liposomal Doxorubicin plus Gemcitabine

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 Name: Oxaliplatin plus Fluorouracil/Leucovorin




Primary Outcome Measures :
  1. Progression-Free-Survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 3 months ]
  2. Overall survival [ Time Frame: 6 months and 12 months ]
  3. Disease control rate [ Time Frame: 3 months ]
  4. Time-to-Progression [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 DOX 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527772


Sponsors and Collaborators
Guangxi Medical University
Investigators
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Study Director: lequn Li, MD GXMU

Publications of Results:
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Responsible Party: Chengcheng Liao, Affiliated Tumor Hospital, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02527772     History of Changes
Other Study ID Numbers: LD-FOX4/HCC
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Gemcitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors