Carcinoma, Hepatocellular
Conditions
Brief summary
Primary: * Overall Survival (OS) Secondary: * Time to Tumor Progression (TTP) * Response Rate (RR) * Improvement of Quality of Life (QoL) * Safety * Secondary resection rate
Interventions
Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion. Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion. Repeated every 2 weeks
DRUGDoxorubicin
Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically, cytologically or clinically diagnosed (in patient with cirrhosis, Alpha-Fetoprotein(AFP)≥400μg/L and morphological evidence \[contrast Computed Tomography(CT)/Magnetic Resonance Imaging(MRI)\] of hypervascular liver tumor, elevated AFP level due to other reasons \[germ cell carcinoma, progressive chronic hepatitis, pregnancy, etc\] can be excluded) unresectable hepatocellular carcinoma, ineligible or if the patient does not consent to receive local invasive treatment (chemo-embolism, ablation, etc.). * At least one measurable lesion (on CT: ≥2cm, on spiral CT or MRI ≥1cm) * Have not received previous palliative systemic chemotherapy for metastatic disease. If the patient received previous systemic chemotherapy as adjuvant treatment, he must have been completed at least 12 months previously. * Patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion, Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 8 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion. * Karnofsky Performance Score≥70, Barcelona of Cancer Liver Category stage B/C * Patients must have adequate organ and marrow function: * Neutrophilus≥1.5X10\^9/L * Platelets≥75X10\^9/L * Asparagine AminoTransferase,Alanine AminoTransferase\<2.5 Upper Normal Limit(UNL) * Total Bilirubin\<1.5 UNL * International Normalized Ratio\<1.5 * Child stage A or B * Normal base line Left Ventricular Ejection Fraction (LVEF result must be above or equal to the lower limit of normal for the institution)
Exclusion criteria
* Documented allergy to platinum compound or to other study drugs. * Any previous oxaliplatin or doxorubicin treatment, except adjuvant treatment more than 12 months before the randomization. * Previous liver transplantation. * Patients concomitantly receiving any other anti-cancer therapy, including interferon-α and herbal medicine which was approved by local authority to be used as anti-cancer medicine, except radiotherapy to non-target lesion (bone metastasis, etc) * Patients who are receiving any other study treatments. * Pregnant or lactating women or women of childbearing potential without proper contraceptive methods. * History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. * Central nervous system metastasis * Other serious illness or medical conditions The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | From the date of randomization to the date of death due to any cause |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | From the date of randomization to documentation of progression |
| Response rate, secondary resection rate, quality of life | From the date of randomization to the end of study |
Countries
China, South Korea, Taiwan, Thailand
Outcome results
None listed