Hepatocellular CancerPhase 1NCT02288507
Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer
A Phase 1 study testing Sorafenib and yttrium-90 radioembolization in people with Hepatocellular Cancer, run by University of Hawaii at 1 site in United States.
Trial summary
This study evaluates the safety and efficacy of administering sorafenib concurrent with yttrium-90 radioembolization to patients with advanced hepatocellular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- Sorafenib and yttrium-90 radioembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- Phase
- Phase 1
- 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 or cytologically confirmed HCC or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. m)
- Barcelona Clinic Liver Cancer Stage B or C. Segmental and subsegmental portal vein thrombosis is allowed.
- Metastatic disease is allowed if investigator feels liver directed therapy could offer palliative benefit (i.e., minimal extrahepatic tumor burden)
- No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7. Eligibility
- Have at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
- Consultation with interventional radiologist and deemed an appropriate candidate for TARE.
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- Prior local therapy, such as surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan.
- Prior yittrium-90 transarterial radioembolization (TARE) or sorafenib not allowed
- Patient must be informed of the investigational nature of this study, sign and give written informed consent in accordance with institutional and federal guidelines.
- Age ≥ 18 years.
- Eastern Cooperative Group (ECOG) performance status ≤ 1.
- Have adequate hematologic function as documented by an absolute neutrophil count (ANC) ≥ 1000/ul, platelet count ≥ 60,000/ul, and hemoglobin ≥ 8.5 mg/dl obtained within 28 days prior to registration.
- Have adequate hepatic function, as determined by the following tests measured within 28 days prior to registration: serum bilirubin ≤ 2 x upper limit of normal (ULN); serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 5 x the institutional upper limit of normal (IULN).
- Have adequate renal function, as determined by the following tests measured within 28 days prior to registration: serum creatinine ≤ 1.5 x ULN OR a measured creatinine clearance or calculated creatinine clearance ≥ 50 mL/min.
- Have a life expectancy of ≥12 weeks
- Must be able to swallow oral medications.
- Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
Who cannot join
- Known or suspected allergy or hypersensitivity to sorafenib.
- Any malabsorption condition.
- Must not have known brain metastases.
- No concurrent anticancer chemotherapy or local therapy.
- No concurrent herbal or unconventional therapy (e.g., St. John's Wort)
- Pregnant or nursing women
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- No prior radiation therapy to the liver
- Inability to perform y90 TARE due to: (1) inability to catheterize the hepatic artery, (2) portal vein thrombosis/occlusion without the ability to perform selective infusion, (3) Tecnetium-99m macro-aggregated albumin hepatic artery perfusion scintigraphy shows unfavorable shunt fraction between the liver and the pulmonary parenchyma as determined by the interventional radiologist, or (4) other contraindication to TARE identified by interventional radiologist.
- Women/men of reproductive potential unwilling or unable to use an effective contraceptive method
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years.
- History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer
This study evaluates the safety and efficacy of administering sorafenib concurrent with yttrium-90 radioembolization to patients with advanced hepatocellular cancer.
Read the detailed description
Studies in Asia of unresectable hepatocellular cancer (HCC) demonstrated that sorafenib could be administered safely at 400mg twice a day (BID) when initiated 14 days following radioembolization (RE). However, the ideal sequence of RE and sorafenib may not be completely elucidated, the two treatments given concurrently may be more effective than the sequential approach studied in the Asian trials. Preclinical models have demonstrated that sorafenib acts synergistically with radiation, increasing apoptosis. Furthermore, case reports suggest profound responses in patients who have received sorafenib concurrent with transarterial radioembolizatoin (TARE) as evidenced by improvement in symptoms, >80% decrease in alpha fetoprotein (AFP), and conversion from unresectable to resectable. Sorafenib concurrent with TARE may take advantage of the synergistic relationship between the two therapies and prove to be a more effective treatment strategy than sequential administration of TARE and sorafenib.
- Conditions
- Hepatocellular Cancer
- Being tested
- Sorafenib, yttrium-90 radioembolization
- Keywords
- sorafenib, yttrium-90 radioembolization
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar, Bay 43-9006 tosylate, Bay 54-9085
Sorafenib 400mg PO BID for Cohort 1, if 2 or more patients with dose-limiting toxicity toxicity (DLT), Chort -1 is sorafenib 200mg PO BID, if 2 or more patients with DLT, sorafenib 200mg PO daily
yttrium-90 radioembolizationRadiation
Also called SIR-Spheres microspheres
Yttrium-90 SIR-Spheres microspheres are instilled through a catheter into a branch of the hepatic artery
| Study group | Role | What they receive |
|---|---|---|
| sorafenib & Yttrium-90 radioembolization | Experimental | Sorafenib dose de-escalation starting at 400mg PO BID starting on Day1 Yttrium-90 radioemoblization on Day 14 Receives: Drug: Sorafenib; Radiation: yttrium-90 radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measures by Adverse events
All patients will be monitored and evaluated for clinical toxicities during the treatment period and queried at each follow-up visit for Adverse Events (AEs). Patients may volunteer information concerning AEs. All AEs will be graded by using the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Measured: 2 months
Secondary outcomes (1)
Efficacy of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measured by response rate, time to progression (TTP), progression free survival (PFS), overall survival (OS)
Response: Response will be evaluated by contrast enhanced MRI or CT and response rates will be reported separately as measured by RECIST and mRECIST criteria. Duration of response will also be measured according to RECIST and mRECIST guidelines.
Survival: The time to progression, progression free survival, and overall survival will be measured. TTP and PFS will be calculated based on progression as defined by RECIST and mRECIST and both intervals will be reported.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Closed due to no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jared Acoba, University of Hawaii
- Investigators
- Jared Acoba, MD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288507
- Sponsor's protocol ID
- Acoba 2014 -1
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2014
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT02288507
- Acronym / sponsor ID
- Acoba 2014 -1
- Conditions
- Hepatocellular Cancer
- Keywords
- sorafenib, yttrium-90 radioembolization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed due to no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Nov 2014 (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.
This study evaluates the safety and efficacy of administering sorafenib concurrent with yttrium-90 radioembolization to patients with advanced hepatocellular cancer.
Detailed description
Studies in Asia of unresectable hepatocellular cancer (HCC) demonstrated that sorafenib could be administered safely at 400mg twice a day (BID) when initiated 14 days following radioembolization (RE). However, the ideal sequence of RE and sorafenib may not be completely elucidated, the two treatments given concurrently may be more effective than the sequential approach studied in the Asian trials. Preclinical models have demonstrated that sorafenib acts synergistically with radiation, increasing apoptosis. Furthermore, case reports suggest profound responses in patients who have received sorafenib concurrent with transarterial radioembolizatoin (TARE) as evidenced by improvement in symptoms, >80% decrease in alpha fetoprotein (AFP), and conversion from unresectable to resectable. Sorafenib concurrent with TARE may take advantage of the synergistic relationship between the two therapies and prove to be a more effective treatment strategy than sequential administration of TARE and sorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sorafenib & Yttrium-90 radioembolization | Experimental | Drug: Sorafenib, Radiation: yttrium-90 radioembolizationSorafenib dose de-escalation starting at 400mg PO BID starting on Day1 Yttrium-90 radioemoblization on Day 14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed HCC or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. m)
- Barcelona Clinic Liver Cancer Stage B or C. Segmental and subsegmental portal vein thrombosis is allowed.
- Metastatic disease is allowed if investigator feels liver directed therapy could offer palliative benefit (i.e., minimal extrahepatic tumor burden)
- No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7. Eligibility
- Have at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
Key exclusion criteria (12 listed)
- Known or suspected allergy or hypersensitivity to sorafenib.
- Any malabsorption condition.
- Must not have known brain metastases.
- No concurrent anticancer chemotherapy or local therapy.
- No concurrent herbal or unconventional therapy (e.g., St. John's Wort)
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 |
|---|---|---|
| SorafenibAlso: Nexavar, Bay 43-9006 tosylate, Bay 54-9085Sorafenib 400mg PO BID for Cohort 1, if 2 or more patients with dose-limiting toxicity toxicity (DLT), Chort -1 is sorafenib 200mg PO BID, if 2 or more patients with DLT, sorafenib 200mg PO daily | Drug | sorafenib & Yttrium-90 radioembolization |
| yttrium-90 radioembolizationAlso: SIR-Spheres microspheresYttrium-90 SIR-Spheres microspheres are instilled through a catheter into a branch of the hepatic artery | Radiation | sorafenib & Yttrium-90 radioembolization |
Primary outcome
Safety and tolerability of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measures by Adverse events
Time frame: 2 months
All patients will be monitored and evaluated for clinical toxicities during the treatment period and queried at each follow-up visit for Adverse Events (AEs). Patients may volunteer information concerning AEs. All AEs will be graded by using the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
1 secondary outcome
Efficacy of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measured by response rate, time to progression (TTP), progression free survival (PFS), overall survival (OS)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Jared Acoba, MD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib and yttrium-90 radioembolization in people with Hepatocellular Cancer, run by University of Hawaii at 1 site in United States.
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 17 inclusion and 12 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: withdrawn, as of the sponsor's last update on 8 Nov 2019. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety and tolerability of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measures by Adverse events (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2019.