Hepatocellular CarcinomaPhase 2NCT01352728
Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
A Phase 2 study testing Axitinib in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 May 2011to 7 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
- Disease must not be amenable to potentially curative surgery
- Without prior systemic nor transarterial treatment
- Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
- Child-Pugh stage A liver function
- ECOG performance 0-2
Show all 9Show fewer
- Life expectancy longer than 12 weeks
- At least one measurable treatment lesion according to modified RECIST criteria
- Adequate haematological, hepatic and renal function
Who cannot join
- Contra-indications to TACE treatment:
- Main portal vein thrombosis or occlusion
- Evidence of biliary obstruction
- Presence of extra-hepatic disease
- Diffuse-type HCC
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
Show all 10Show fewer
- Any form of prior transarterial therapy or systemic therapy for HCC.
- Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
- 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.
- Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Axitinib
- Keywords
- Unresectable
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
| Study group | Role | What they receive |
|---|---|---|
| TACE+Axitinib | Experimental | Not described Receives: Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year survival rate
Measured: 4 years
Secondary outcomes (9)
Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
Measured: 4 years
Disease Control Rate (DCR)
Measured: 4 Years
Duration of Response (DR)
Measured: 4 years
Time to Progression (TTP)
Measured: 4 years
Progression-Free Survival (PFS)
Measured: 4 years
Overall survival (OS)
Measured: 4 years
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Measured: 4 years
Quality of Life
Measured: 4 years
Tissue and Serum Biomarkers
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study start18 May 2011
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Stephen L Chan, MRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352728
- Sponsor's protocol ID
- HCC028
- Status last verified
- Jun 2018
- First submitted
- 11 May 2011
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28640364
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01352728
- Acronym / sponsor ID
- HCC028
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Unresectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 18 May 2011 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE+Axitinib | Experimental | Drug: Axitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
- Disease must not be amenable to potentially curative surgery
- Without prior systemic nor transarterial treatment
- Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
- Child-Pugh stage A liver function
Key exclusion criteria (10 listed)
- Contra-indications to TACE treatment:
- Diffuse-type HCC
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
- Any form of prior transarterial therapy or systemic therapy for HCC.
- Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axitinib5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD. | Drug | TACE+Axitinib |
Primary outcome
Two-year survival rate
Time frame: 4 years
9 secondary outcomes
Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 Years
Duration of Response (DR)
Time frame: 4 years
Time to Progression (TTP)
Time frame: 4 years
Progression-Free Survival (PFS)
Time frame: 4 years
Overall survival (OS)
Time frame: 4 years
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Time frame: 4 years
Quality of Life
Time frame: 4 years
Tissue and Serum Biomarkers
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Derived from this study: PubMed 28640364Chan 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.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L Chan, MRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axitinib in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year survival rate (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.