Clinical trial · Interventional
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma
NCT00142467CI-TRIAL-00014047completedPhase 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)
The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab, Gemcitabine, Oxaliplatin
- description
- For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.
- interventionNames
- Drug: Gemcitabine
- Drug: Oxaliplatin
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
- timeFrame
- 2 years
- description
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable or metastatic hepatocellular carcinoma * Measurable tumors * Adequate hepatic function: total bilirubin \< 3.0mg/dl; AST \< 7x ULN * Adequate bone marrow function: ANC \> 1,000/mm3; platelets \> 75,000/mm3 * INR \< 1.5 for those who are not on anticoagulation * Up to two prior chemotherapy regimens for hepatocellular carcinoma * 18 years of age or older * ECOG performance status of 0-1 * Life expectancy of \> 12 weeks Exclusion Criteria: * Clinically apparent central nervous system metastases or carcinomatous meningitis * Uncontrolled serious medical or psychiatric illness * Pregnant or lactating women * Current or recent (within 4 weeks of first study infusion) participation in experimental study drug * Uncontrolled hypertension * Significant proteinuria * Serious, non-healing wound, ulcer, or bone fracture * Evidence of bleeding diathesis or coagulopathy
References
Publications (0)
Data not yet available
No reference posted for this study.