Clinical trial NCT00471965 (phase 3, status: completed)
Conditions: carcinoma, hepatocellular
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: oxaliplatin + 5-fluorouracil/leucovorin, doxorubicin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        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.