Clinical trial · Interventional
Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
A Phase II Study of Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
NCT00142428CI-TRIAL-00014048completedPhase 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 main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- description
- The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks.
- interventionNames
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Progression free survival in patients treated with cetuximab for unresectable or metastatic hepatocellular carcinoma
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Number of patients with adverse events
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable or metastatic hepatocellular carcinoma * Measurable tumor * Adequate hepatic function: total bilirubin \< 3.0mg/dl; AST \< 7 x upper limit of normal (ULN). * Adequate renal function: serum creatinine \< 2.0mg/dl * Adequate bone marrow function: absolute neutrophil count (ANC) \> 1,000/mm3; platelets \> 75,000/mm3. * 0-2 prior systemic chemotherapy regimens for hepatocellular carcinoma * 18 years of age and older * ECOG performance status of 0-2 * Life expectancy \> 12 weeks Exclusion Criteria: * Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry * Uncontrolled serious medical or psychiatric illness * Irradiation or chemotherapy for disease within 28 days of study entry * Clinically apparent central nervous system metastases or carcinomatous meningitis * Received an investigational agent within 30 days * Cancer of the Liver Italian Program (CLIP) score \> 3 * Acute hepatitis * Active or uncontrolled infection * Significant history of cardiac disease * Prior cetuximab or other therapy which specifically and directly targets the EGFR pathway * Prior allergic reaction to chimerized or murine monoclonal antibody therapy
References
Publications (0)
Data not yet available
No reference posted for this study.