Hepatocellular CancerLiverNCT02787954

Prospective Tumor Response Evaluation

An observational study of Hepatocellular Cancer and Metastatic Liver Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine if MRI imaging can detect genetic, proteomic, and metabolomic characteristics of liver tumors. The study also aims to determine if these imaging characteristics are correlated with clinical outcomes. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hepatocellular Cancer, Metastatic Liver Cancer
What is being tested?: TACE, Y-90 and MWA
Type of treatment: Surgery or procedure
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Apr 2017
How long will I take part?: 5 Years
Phase: Observational
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with primary or metastatic liver cancer, who are deemed candidates for TACE, electroporation, MWA, or Y90 will be enrolled. The patients will be recruited from medical oncology, surgical oncology, gastroenterology, and transplant surgery services.

Who may be able to join

Diagnosis or suspicion of primary or metastatic liver cancer deemed eligible for TACE, Y-90, percutaneous ablation, and /or electroporation.

Who cannot join

Any reason MRI cannot be obtained.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Prospective Evaluation of Tumor Response to Cancer Treatment Therapies

Read the detailed description

For each treatment arm, pre-procedural MRI and post procedural MRI will be obtained. Pre-procedural biopsies will be obtained, if possible. Pretreatment genetic expression, proteomic, or metabolomic patterns from the tumor samples will be assessed. Imaging characteristics from tumors will be extracted using automated software-the study will apply a computational analysis system with the capability to extract and analyze imaging characteristics and correlate them to genetic expression, proteomic, and metabolomic tumor characteristics. Imaging findings will be correlated to clinical outcomes and genetic, proteomic, and metabolomic findings to determine association. Imaging findings and genomic, proteomic, and metabolomic tumor characteristics will be correlated to clinical outcomes (time to recurrence, overall survival, 3-month, 6-month, and 1-year survival).

Conditions: Hepatocellular Cancer, Metastatic Liver Cancer
Being tested: TACE, Y-90, MWA, IRE
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TACEProcedure or surgery
Also called Transcatheter arterial chemoembolization
Procedure for giving chemotherapy directly to tumor cells.
Y-90Procedure or surgery
Also called Yittrium 90
Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.
MWAProcedure or surgery
Also called Microwave Ablation
Using heat to kill tumor cells.
IREProcedure or surgery
Also called Irreversible Electroporation
Using energy to disrupt tumor cell activity, thereby causing cellular death.

Study groups in NCT02787954
Study group	Role	What they receive
Transcatheter Chemoembolization or TACE		A technique called transcatheter chemoembolization (TACE) is used for some patients with liver cancer that cannot be treated surgically. The procedure is a way of delivering cancer treatment directly to a tumor through minimally-invasive means. Receives: Procedure: TACE
Yittrium 90 or Y-90		Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to treat liver cancer. Tiny glass or resin beads filled with the radioactive isotope yttrium Y-90 are placed inside the blood vessels that feed a tumor. This blocks the supply of blood to the cancer cells and delivers a high dose of radiation to the tumor while sparing normal tissue. Receives: Procedure: Y-90
Microwave Ablation or MWA		Microwave ablation (MWA), destroys liver tumors using heat generated by microwave energy. A CT scan or ultrasonic guidance is used to pinpoint the exact location of the tumor. A thin antenna, which emits microwaves, is then inserted into the tumor. The probe produces intense heat that ablates (destroys) tumor tissue, often within 10 minutes. Receives: Procedure: MWA
electroporation		Irreversible electroporation (IRE) is a nonthermal method of destroying the cell. A cell is subjected to a powerful electrical field using high-voltage direct current (up to 3 kV); this creates multiple holes in the cell membrane and irreversibly damages the cell's homeostasis mechanism, leading to instant cell death. Receives: Procedure: IRE

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to progression
Time from initial treatment to progression as defined by RECIST criteria.
Measured: 1 month to 3 years

Secondary outcomes (1)

1 year survival
Number of patients alive 1 year after treatment
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Apr 2017

First posted1 Jun 2016 (estimated)
Study startJan 2016
Primary completionApr 2017
Study completionApr 2017

Why it stopped: PI transferred to another institution and did not take this study with him.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 10 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02787954
Sponsor's protocol ID: HSC-MS-14-0761
Acronym: Liver
Status last verified: Oct 2018
First submitted: 26 May 2016
Last updated: 18 Oct 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.
PubMed 22353262
Gu L, Liu H, Fan L, Lv Y, Cui Z, Luo Y, Liu Y, Li G, Li C, Ma J. Treatment outcomes of transcatheter arterial chemoembolization combined with local ablative therapy versus monotherapy in hepatocellular carcinoma: a meta-analysis. J Cancer Res Clin Oncol. 2014 Feb;140(2):199-210. doi: 10.1007/s00432-013-1528-8.
PubMed 24077865
Raoul JL, Gilabert M, Piana G. How to define transarterial chemoembolization failure or refractoriness: a European perspective. Liver Cancer. 2014 May;3(2):119-24. doi: 10.1159/000343867.
PubMed 24945002
Assumpcao L, Choti M, Pawlik TM, Gecshwind JF, Kamel IR. Functional MR imaging as a new paradigm for image guidance. Abdom Imaging. 2009 Nov;34(6):675-85. doi: 10.1007/s00261-008-9481-8. Epub 2008 Dec 2.
PubMed 19048335
Bian DJ, Xiao EH, Hu DX, Chen XY, Situ WJ, Yuan SW, Sun JL, Yang LP. Magnetic resonance spectroscopy on hepatocellular carcinoma after transcatheter arterial chemoembolization. Chin J Cancer. 2010 Feb;29(2):198-201.
PubMed 20109351
Minami Y, Kudo M. Therapeutic response assessment of transcatheter arterial chemoembolization for hepatocellular carcinoma: ultrasonography, CT and MR imaging. Oncology. 2013;84 Suppl 1:58-63. doi: 10.1159/000345891. Epub 2013 Feb 20.
PubMed 23428860
Karlo CA, Di Paolo PL, Chaim J, Hakimi AA, Ostrovnaya I, Russo P, Hricak H, Motzer R, Hsieh JJ, Akin O. Radiogenomics of clear cell renal cell carcinoma: associations between CT imaging features and mutations. Radiology. 2014 Feb;270(2):464-71. doi: 10.1148/radiol.13130663. Epub 2013 Oct 28.
PubMed 24029645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
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Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
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RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
Active, not recruitingPhase 2
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers
Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer

All Hepatocellular Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of Tumor Response to Cancer Treatment Therapies
ClinicalTrials.gov ID: NCT02787954
Acronym / sponsor ID: Liver / HSC-MS-14-0761
Conditions: Hepatocellular Cancer, Metastatic Liver Cancer
Study type: Observational
Recruitment status: TerminatedReason stopped: PI transferred to another institution and did not take this study with him.
Enrolment: 10 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Jan 2016 (actual)
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 1 Jun 2016 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 4

Arm	Type	Receives
Transcatheter Chemoembolization or TACE	–	Procedure: TACEA technique called transcatheter chemoembolization (TACE) is used for some patients with liver cancer that cannot be treated surgically. The procedure is a way of delivering cancer treatment directly to a tumor through minimally-invasive means.
Yittrium 90 or Y-90	–	Procedure: Y-90Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to treat liver cancer. Tiny glass or resin beads filled with the radioactive isotope yttrium Y-90 are placed inside the blood vessels that feed a tumor. This blocks the supply of blood to the cancer cells and delivers a high dose of radiation to the tumor while sparing normal tissue.
Microwave Ablation or MWA	–	Procedure: MWAMicrowave ablation (MWA), destroys liver tumors using heat generated by microwave energy. A CT scan or ultrasonic guidance is used to pinpoint the exact location of the tumor. A thin antenna, which emits microwaves, is then inserted into the tumor. The probe produces intense heat that ablates (destroys) tumor tissue, often within 10 minutes.
electroporation	–	Procedure: IREIrreversible electroporation (IRE) is a nonthermal method of destroying the cell. A cell is subjected to a powerful electrical field using high-voltage direct current (up to 3 kV); this creates multiple holes in the cell membrane and irreversibly damages the cell's homeostasis mechanism, leading to instant cell death.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with primary or metastatic liver cancer, who are deemed candidates for TACE, electroporation, MWA, or Y90 will be enrolled. The patients will be recruited from medical oncology, surgical oncology, gastroenterology, and transplant surgery services.

Key inclusion criteria (1 listed)

Diagnosis or suspicion of primary or metastatic liver cancer deemed eligible for TACE, Y-90, percutaneous ablation, and /or electroporation.

Key exclusion criteria (1 listed)

Any reason MRI cannot be obtained.

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
TACEAlso: Transcatheter arterial chemoembolizationProcedure for giving chemotherapy directly to tumor cells.	Procedure or surgery	Transcatheter Chemoembolization or TACE
Y-90Also: Yittrium 90Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.	Procedure or surgery	Yittrium 90 or Y-90
MWAAlso: Microwave AblationUsing heat to kill tumor cells.	Procedure or surgery	Microwave Ablation or MWA
IREAlso: Irreversible ElectroporationUsing energy to disrupt tumor cell activity, thereby causing cellular death.	Procedure or surgery	electroporation

Primary outcome

Time to progression
Time frame: 1 month to 3 years
Time from initial treatment to progression as defined by RECIST criteria.

1 secondary outcome

1 year survival
Time frame: 1 year

Results and safety

The study was stopped early (reason given: PI transferred to another institution and did not take this study with him.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Background: PubMed 22353262Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.
Background: PubMed 24077865Gu L, Liu H, Fan L, Lv Y, Cui Z, Luo Y, Liu Y, Li G, Li C, Ma J. Treatment outcomes of transcatheter arterial chemoembolization combined with local ablative therapy versus monotherapy in hepatocellular carcinoma: a meta-analysis. J Cancer Res Clin Oncol. 2014 Feb;140(2):199-210. doi: 10.1007/s00432-013-1528-8.
Background: PubMed 24945002Raoul JL, Gilabert M, Piana G. How to define transarterial chemoembolization failure or refractoriness: a European perspective. Liver Cancer. 2014 May;3(2):119-24. doi: 10.1159/000343867.
Background: PubMed 19048335Assumpcao L, Choti M, Pawlik TM, Gecshwind JF, Kamel IR. Functional MR imaging as a new paradigm for image guidance. Abdom Imaging. 2009 Nov;34(6):675-85. doi: 10.1007/s00261-008-9481-8. Epub 2008 Dec 2.
Background: PubMed 20109351Bian DJ, Xiao EH, Hu DX, Chen XY, Situ WJ, Yuan SW, Sun JL, Yang LP. Magnetic resonance spectroscopy on hepatocellular carcinoma after transcatheter arterial chemoembolization. Chin J Cancer. 2010 Feb;29(2):198-201.
Background: PubMed 23428860Minami Y, Kudo M. Therapeutic response assessment of transcatheter arterial chemoembolization for hepatocellular carcinoma: ultrasonography, CT and MR imaging. Oncology. 2013;84 Suppl 1:58-63. doi: 10.1159/000345891. Epub 2013 Feb 20.
Background: PubMed 24029645Karlo CA, Di Paolo PL, Chaim J, Hakimi AA, Ostrovnaya I, Russo P, Hricak H, Motzer R, Hsieh JJ, Akin O. Radiogenomics of clear cell renal cell carcinoma: associations between CT imaging features and mutations. Radiology. 2014 Feb;270(2):464-71. doi: 10.1148/radiol.13130663. Epub 2013 Oct 28.
Individual participant dataSharing planned: No

Related trials for Hepatocellular Cancer

RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
Active, not recruitingPhase 2
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers
Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer

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.

Derek L West, MD principal investigator

University of Texas Healtlh Science Center at Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Cancer and Metastatic Liver Cancer, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Oct 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 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.

Are results available for this study?

The study was stopped early (reason given: PI transferred to another institution and did not take this study with him.). Results are not available in the source record.

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?

Time to progression (time frame: 1 month to 3 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 NCT02787954, which also lists 7 linked publications.

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 Oct 2018.