Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments liposomal doxorubicin+gemcitabine, folfox4
Phase phase 2/phase 3
Sponsor Guangxi Medical University
Start date September 2015
End date September 2017
Trial size 90 participants
Trial identifier NCT02527772, LD-FOX4/HCC

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Gemcitabine 1000mg/m2,d1,8;Liposomal Doxorubicin 30mg/m2,d1.q4w
liposomal doxorubicin+gemcitabine Liposomal Doxorubicin plus 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.
(Active Comparator)
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
folfox4 Oxaliplatin plus Fluorouracil/Leucovorin
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.

Primary Outcomes

Measure
Progression-Free-Survival
time frame: 6 months

Secondary Outcomes

Measure
Objective response rate
time frame: 3 months
Overall survival
time frame: 6 months and 12 months
Disease control rate
time frame: 3 months
Time-to-Progression
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Liposomal Doxorubicin(LD) Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Guangxi Medical University.