Clinical trial · Interventional
Oxaliplatin in Unresectable Hepatocellular Carcinoma
Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
NCT00280618CI-TRIAL-00002623completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary: * To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin Secondary: * Safety and tolerability of this regimen in these patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
- timeFrame
- During the Study Conduct
Secondary outcomes (1)
- measure
- Adverse Events collections and evaluation
- timeFrame
- From the signature of the informed consent up to the end of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.