Hepatocellular CarcinomaPhase 2/3STARTNCT01901692
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion
A Phase 2/3 study testing TACE+External beam RT and Sorafenib in people with Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE+External beam RT and Sorafenib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2013to 31 Aug 2017
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >19 years
- Child-Pugh class A liver function
- Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy
- HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava
- Reserved unilateral portal blood flow at least in partial
Show all 12Show fewer
- HCC size larger than 1 cm and less than 50% of total liver volume
- No confirmed extrahepatic metastasis
- Adequate hematopoietic function Hemoglobin ≥ 8.5 g/dL Absolute neutrophil count ≥ 750/mm3 Platelet count ≥ 30,000/mm3
- Creatinine < 1.5mg/dL
- No plan for pregnancy or breast feeding. Active contraception.
- Willing to give informed consent
Who cannot join
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Confirmed extrahepatic metastasis of HCC
- HCC occupying more than 50% of liver volume
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
Show all 10Show fewer
- Positive for human immunodeficiency virus (HIV)
- Active gastric or duodenal ulcer
- Other uncontrolled comorbidities or malignancy
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion
To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels
Read the detailed description
Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE+External beam RT, Sorafenib
- Keywords
- liver cancer, first-line, tumor thrombus, vascular invasion
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE+External beam RTRadiation
Trans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE
SorafenibDrug
Also called Nexavar
Sorafenib 800 mg/day orally
| Study group | Role | What they receive |
|---|---|---|
| TACE+External beam RT | Experimental | Transarterial chemoembolization plus external beam radiation therapy Receives: Radiation: TACE+External beam RT |
| Sorafenib | Active comparator | Sorafenib 800 mg/day orally Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
Measured: at 12 weeks after randomization
Secondary outcomes (6)
Progression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Measured: at 24 weeks and up to 4 years after randomization
Radiologic response rate
Radiologic response rate by independent radiologic review according to RECIST criteria (version 1.1), , assessed by Chi-square test or Fisher's exact test, as appropriate.
Measured: at 12 and 24 weeks after randomization
treatment-crossover rate
Crossover of treatment is permitted after confirming the disease progression during the initially assigned treatment, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Measured: at 12 and 24 weeks after randomization
time to progression
The median time to progression assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Measured: up to 4 years after randomization
Overall patient survival rate
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Measured: up to 4 years after randomization
Exploratory analysis for overall patient survival rate
By using Cox proportional hazards model to evaluate the interaction between important baseline characteristics and the effect of treatments on overall survival.
Measured: up to 4 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study start29 Jul 2013
- Primary completion20 Jan 2017
- Study completion31 Aug 2017
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 Asan Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Suk Lim, Asan Medical Center
- Investigators
- Young-Suk Lim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901692
- Sponsor's protocol ID
- AMC IRB 2013-0627
- Acronym
- START
- Status last verified
- Sep 2017
- First submitted
- 14 Jul 2013
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.
PubMed 29543938
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion
- ClinicalTrials.gov ID
- NCT01901692
- Acronym / sponsor ID
- START / AMC IRB 2013-0627
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer, first-line, tumor thrombus, vascular invasion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 29 Jul 2013 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 17 Jul 2013 (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.
To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels
Detailed description
Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+External beam RT | Experimental | Radiation: TACE+External beam RTTransarterial chemoembolization plus external beam radiation therapy |
| Sorafenib | Active comparator | Drug: SorafenibSorafenib 800 mg/day orally |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >19 years
- Child-Pugh class A liver function
- Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy
- HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava
Key exclusion criteria (10 listed)
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Confirmed extrahepatic metastasis of HCC
- HCC occupying more than 50% of liver volume
- Uncontrolled ascites of hepatic encephalopathy
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 |
|---|---|---|
| TACE+External beam RTTrans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE | Radiation | TACE+External beam RT |
| SorafenibAlso: NexavarSorafenib 800 mg/day orally | Drug | Sorafenib |
Primary outcome
Progression-free survival (PFS) rate
Time frame: at 12 weeks after randomization
Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
6 secondary outcomes
Progression-free survival (PFS) rate
Time frame: at 24 weeks and up to 4 years after randomization
Radiologic response rate
Time frame: at 12 and 24 weeks after randomization
treatment-crossover rate
Time frame: at 12 and 24 weeks after randomization
time to progression
Time frame: up to 4 years after randomization
Overall patient survival rate
Time frame: up to 4 years after randomization
Exploratory analysis for overall patient survival rate
Time frame: up to 4 years after randomization
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 18 Sep 2017.
- Derived from this study: PubMed 29543938Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.
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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.
Young-Suk Lim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TACE+External beam RT and Sorafenib in people with Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
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 12 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 18 Sep 2017. 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 South Korea. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-free survival (PFS) rate (time frame: at 12 weeks after randomization). 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 NCT01901692, 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 18 Sep 2017.