Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients

Oxaliplatin(Eloxatin®) + 5-FU/LV (FOLFOX4) Compared With Single Agent Doxorubicin (Adriamycin®) as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients Ineligible for Curative Resection or Local Treatment

Primary:

• Overall Survival (OS)

Secondary:

• Time to Tumor Progression (TTP)
• Response Rate (RR)
• Improvement of Quality of Life (QoL)
• Safety
• Secondary resection rate

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.