Clinical trial · Interventional
Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma
A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
NCT01334112CI-TRIAL-00042199AXITINIBcompletedPhase 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 evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)
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 |
|---|---|---|---|
| Axitinib (AG-013736) | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axitinib
- description
- Oral Axitinib (5mg, twice daily) will be administered to all patients
- interventionNames
- Drug: Axitinib (AG-013736)
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Response rate assessed by CT scan at 16 weeks
Secondary outcomes (7)
- measure
- Feasibility
- timeFrame
- Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
- description
- The ability to administer one or more cycles of Axitinib to \>70% of patients at a dose of 5mg po BID
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable and/or metastatic Hepatocellular Carcinoma * Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs * Life expectancy of ≥12 weeks * At least one tumor lesion * At least 2 weeks since the end of prior systemic treatment * No evidence of pre-existing uncontrolled hypertension * ECOG 0 or 1 * Adequate organ function * Not appropriate for curative therapy * Child A or B7 cirrhosis * CLIP score ≤ 4 Exclusion Criteria: * Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment * Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment * Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma * Severe acute or chronic medical or psychiatric condition * Need for treatment with prohibited drugs * Has received local therapy to all measurable lesions * Stage B8 or higher liver cirrhosis * Ascites refractory to diuretic therapy * Clinically significant ECG abnormality
References
Publications (0)
Data not yet available
No reference posted for this study.