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
- 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
- Karnofsky Performance Score≥70, Barcelona of Cancer Liver Category stage B/C
- Patients must have adequate organ and marrow function:
- 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)
- 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,
- Patients who are receiving any other study treatments.
- Pregnant or lactating women or women of childbearing potential without proper
- 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.