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Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma

Phase 2
18 Years
75 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma

Inclusion Criteria

Lists of Inclusion and Exclusion criteria:

- Patients must have histologically confirmed hepatocellular carcinoma

- Patients must have measurable disease by CT scan

- Have not received previous palliative systemic chemotherapy for metastatic disease.
(Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.)

- 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 4 weeks
after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target

- WHO 0-2 grades (Karnofsky Performance Score ≥ 70)

- Patients must have adequate organ and marrow function:

- Neutrophilus ≥ 1.5 x 10^9/L

- Platelets ≥ 75 x 10^9/L

- Asparagine AminoTransferase, Alanine AminoTransferase < 2.5 x Upper Normal

- Total Bilirubin ≤ 1.5 x UNL

- International Normalized Ratio < 1.5

- Child stage A or B

- Creatinine ≤ 1.5 X UNL

Exclusion Criteria:

- Documented allergy to platinum compound or to other study drugs.

- Active Gastro-Intestinal bleeding and active haematologic malignancy

- Previous liver transplantation.

- Patients concomitantly receiving any other anti-cancer therapy.

- 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

- Neuropathy ≥ grade 2

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan

Outcome Time Frame:

every 6 weeks

Safety Issue:


Principal Investigator

Hyang Rim Kim

Investigator Role:

Study Director

Investigator Affiliation:



Korea: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

January 2010

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular