Clinical trial · Interventional
Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
NCT00559455CI-TRIAL-00005108completedPhase 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 objective: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV Secondary objective: To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Oxaliplatin
- Drug: Fluorouracil
- Drug: Leucovorin
Primary outcomes (1)
- 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
- timeFrame
- every 6 weeks
Secondary outcomes (1)
- measure
- Time to Progression (TTP), 6 month survival, overall survival, AFP
- timeFrame
- from the signature of Informed Consent up to end of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 lesion. * 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 Limit(UNL) * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.