Clinical trial · Interventional
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
NCT01273662CI-TRIAL-00025876completedPhase 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)
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC). The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.
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 |
|---|---|---|---|
| AG-013736 | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axitinib
- interventionNames
- Drug: AG-013736
Primary outcomes (1)
- measure
- disease stabilization
- timeFrame
- 8 weeks until tumor progression
Secondary outcomes (1)
- measure
- time-to-tumor progression
- timeFrame
- 8 weeks until tumor progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically diagnosed HCC, OR clinically diagnosed HCC * Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy * Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC * At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure * ECOG performance status 0 or 1 * Life expectancy is at least 2 months * Child-Pugh class A liver function. Exclusion Criteria: * Systemic therapy other than sorafenib as first-line therapy for advanced HCC * History of HCC tumor rupture * Presence of brain or leptomeningeal metastases * Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding * History of upper gastrointestinal bleeding within 1 year * Major systemic diseases that the investigator considers inappropriate for participation * Uncontrollable hypertension * Proteinuria * Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers * Requirement of anticoagulant therapy with oral vitamin K antagonists * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
References
Publications (0)
Data not yet available
No reference posted for this study.