Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT00280618
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed hepatocellular carcinoma
* Patients must have measurable disease by CT scan
* Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
* The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
* WHO performance status: 0 to 2
* Patients must have adequate organ and marrow function as defined below:
* Leukocytes : ≥ 3,000/μl
* Absolute neutrophil count :≥ 1,500/μl
* Platelets : ≥ 80,000/μl
* Total bilirubin : \< 3.0g/dl
* ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
* Creatinine : \< 120μmol/l
* Patients with no evidence of clinically significant neuropathy.
Exclusion Criteria:
* Documented allergy to platinum compound or to others study's drugs
* Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
* Hematological disorder or malignancies
* Metastasis to central nervous system
* Other serious illness or medical conditions:
* Active infectious disease
* Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.
* Concurrent treatment with any other anticancer therapy
* Concurrent treatment with other experimental drugs.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00280618
Study Brief:
Protocol Section:
NCT00280618