Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
NCT ID: NCT01352728
Last Updated: 2018-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2011-05-18
2018-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TACE+Axitinib
Axitinib
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
Interventions
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Axitinib
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CCTU
Comprehensive Clinical Trial Unit
Principal Investigators
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Stephen L Chan, MRCP
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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References
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Chan 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.
Other Identifiers
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HCC028
Identifier Type: -
Identifier Source: org_study_id
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