Clinical trial · Interventional
Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
NCT01352728CI-TRIAL-00033377completedPhase 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 survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
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 | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE+Axitinib
- interventionNames
- Drug: Axitinib
Primary outcomes (1)
- measure
- Two-year survival rate
- timeFrame
- 4 years
Secondary outcomes (9)
- measure
- Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
- timeFrame
- 4 years
- measure
- Disease Control Rate (DCR)
- timeFrame
- 4 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible) 2. Disease must not be amenable to potentially curative surgery 3. Without prior systemic nor transarterial treatment 4. Prior surgery or local therapy is allowed but the target lesion must have not been previously treated 5. Child-Pugh stage A liver function 6. ECOG performance 0-2 7. Life expectancy longer than 12 weeks 8. At least one measurable treatment lesion according to modified RECIST criteria 9. Adequate haematological, hepatic and renal function Exclusion Criteria: 1. Contra-indications to TACE treatment: * Main portal vein thrombosis or occlusion * Evidence of biliary obstruction * Presence of extra-hepatic disease 2. Diffuse-type HCC 3. Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment. 4. Any form of prior transarterial therapy or systemic therapy for HCC. 5. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers. 6. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed. 7. Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
References
Publications (1)
- DERIVEDChan SL, Yeo W, Mo F, Chan AWH, Koh J, Li L, Hui EP, Chong CCN, Lai PBS, Mok TSK, Yu SCH. A phase 2 study of the efficacy and biomarker on the combination of transarterial chemoembolization and axitinib in the treatment of inoperable hepatocellular carcinoma. Cancer. 2017 Oct 15;123(20):3977-3985. doi: 10.1002/cncr.30825. Epub 2017 Jun 22. PMID 28640364