Hepatocellular CarcinomaNCT03203837
Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®
An observational study of Hepatocellular Carcinoma, run by Northwestern University at 1 site in United States.
Trial summary
To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Plasma collection
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to 6 Jan 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with hepatocellular carcinoma who will be receiving lobar TheraSphere radioembolization.
Who may be able to join
- Must have the diagnosis of HCC (biopsy or imaging criteria)
- Must have planned lobar TheraSphere treatment
- Must be able to give consent
- Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
- Must have a life expectancy of ≥ 3 months
- Women must not be pregnant with an acceptable contraception in premenopausal women
Show all 9Show fewer
- Must be > 4 weeks since prior radiation
- Must be > 2 weeks since liver surgery
- Must be ≥ 2 weeks post radiosensitizing chemotherapy or > 6 weeks since prior BCNU (carmustine) or Mitomycin-C
Who cannot join
- Patients are excluded if they do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.
Read the detailed description
Patients who have planned lobar radioembolization (TheraSphere (TS)) and consent to this study will have peripheral blood samples collected pre-TS, post-TS, 4 hours post-TS, 24 hours post-TS, 3 days post-TS, 7 days post-TS and 30 days post-TS to analyze specific angiogenic, inflammatory and immune profiles.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Plasma collection
- Keywords
- Radioembolization, Y90, TheraSphere, HCC, Biomarker, Prognostic factor, Angiogenesis, Inflammatory, Liver
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma collectionOther
We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | HCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment. Receives: Other: Plasma collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in angiogenic, inflammatory and immune biomarkers
The percent of change at 7 different timepoints for the following biomarkers will be calculated: Ang-2, FGFb, HB-EGF, HGF, PDGF-BB, PIGF, SDF-1, VEGF, VEGFC, IFNg, IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, TNFa trimer, CRP, TGFb1, EGFR, PD-1, PD-L1, CD45RA, CD127, HLA-DR, CD62L, CD3, CD8, CD197, CCR7, CD45RO, PD-L2, FOXP3, Perforin, Granzyme, TIA-1, CD14, CD107a, CD25, CD45, CD4, CD20 and CD56+16.
Measured: 2 years
Secondary outcomes (4)
Treatment Response- AFP
Alphafetoprotein will be measured in ng/mL.
Measured: 2 years
Treatment Response - Imaging
Lesions will be measured using mRECIST.
Measured: 2 years
Treatment Response- Time-to-Progression
Time-to-progression will be measured in days.
Measured: 2 years
Treatment Response- Overall Survival
Overall survival will be measured in days.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start5 Jul 2017
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Why it stopped: Funding Discontinued due to low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)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 Northwestern UniversityThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Principal investigator, Robert Lewandowski, Northwestern University
- Investigators
- Robert Lewandowski, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203837
- Sponsor's protocol ID
- STU000201854
- Status last verified
- Sep 2020
- First submitted
- 20 Jun 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poon RT, Ng IO, Lau C, Zhu LX, Yu WC, Lo CM, Fan ST, Wong J. Serum vascular endothelial growth factor predicts venous invasion in hepatocellular carcinoma: a prospective study. Ann Surg. 2001 Feb;233(2):227-35. doi: 10.1097/00000658-200102000-00012.
PubMed 11176129Ng IO, Lai EC, Fan ST, Ng MM, So MK. Prognostic significance of pathologic features of hepatocellular carcinoma. A multivariate analysis of 278 patients. Cancer. 1995 Dec 15;76(12):2443-8. doi: 10.1002/1097-0142(19951215)76:123.0.co;2-f.
PubMed 8625069Finkenzeller G, Marme D, Weich HA, Hug H. Platelet-derived growth factor-induced transcription of the vascular endothelial growth factor gene is mediated by protein kinase C. Cancer Res. 1992 Sep 1;52(17):4821-3.
PubMed 1511446Stavri GT, Hong Y, Zachary IC, Breier G, Baskerville PA, Yla-Herttuala S, Risau W, Martin JF, Erusalimsky JD. Hypoxia and platelet-derived growth factor-BB synergistically upregulate the expression of vascular endothelial growth factor in vascular smooth muscle cells. FEBS Lett. 1995 Jan 30;358(3):311-5. doi: 10.1016/0014-5793(94)01458-d.
PubMed 7843420Mann CD, Neal CP, Garcea G, Manson MM, Dennison AR, Berry DP. Prognostic molecular markers in hepatocellular carcinoma: a systematic review. Eur J Cancer. 2007 Apr;43(6):979-92. doi: 10.1016/j.ejca.2007.01.004. Epub 2007 Feb 8.
PubMed 17291746Wada H, Nagano H, Yamamoto H, Yang Y, Kondo M, Ota H, Nakamura M, Yoshioka S, Kato H, Damdinsuren B, Tang D, Marubashi S, Miyamoto A, Takeda Y, Umeshita K, Nakamori S, Sakon M, Dono K, Wakasa K, Monden M. Expression pattern of angiogenic factors and prognosis after hepatic resection in hepatocellular carcinoma: importance of angiopoietin-2 and hypoxia-induced factor-1 alpha. Liver Int. 2006 May;26(4):414-23. doi: 10.1111/j.1478-3231.2006.01243.x.
PubMed 16629644Bassullu N, Turkmen I, Dayangac M, Yagiz Korkmaz P, Yasar R, Akyildiz M, Yaprak O, Tokat Y, Yuzer Y, Bulbul Dogusoy G. The Predictive and Prognostic Significance of c-erb-B2, EGFR, PTEN, mTOR, PI3K, p27, and ERCC1 Expression in Hepatocellular Carcinoma. Hepat Mon. 2012 Oct;12(10 HCC):e7492. doi: 10.5812/hepatmon.7492. Epub 2012 Oct 11.
PubMed 23162604Ito Y, Takeda T, Sakon M, Tsujimoto M, Higashiyama S, Noda K, Miyoshi E, Monden M, Matsuura N. Expression and clinical significance of erb-B receptor family in hepatocellular carcinoma. Br J Cancer. 2001 May 18;84(10):1377-83. doi: 10.1054/bjoc.2000.1580.
PubMed 11355950Tang Z, Qin L, Wang X, Zhou G, Liao Y, Weng Y, Jiang X, Lin Z, Liu K, Ye S. Alterations of oncogenes, tumor suppressor genes and growth factors in hepatocellular carcinoma: with relation to tumor size and invasiveness. Chin Med J (Engl). 1998 Apr;111(4):313-8.
PubMed 10374394Altimari A, Fiorentino M, Gabusi E, Gruppioni E, Corti B, D'Errico A, Grigioni WF. Investigation of ErbB1 and ErbB2 expression for therapeutic targeting in primary liver tumours. Dig Liver Dis. 2003 May;35(5):332-8. doi: 10.1016/s1590-8658(03)00077-x.
PubMed 12846405Lee TY, Kim KT, Han SY. Expression of ErbB receptor proteins and TGF-alpha during diethylnitrosamine-induced hepatocarcinogenesis in the rat liver. Korean J Hepatol. 2007 Mar;13(1):70-80.
PubMed 17380077Tanabe KK, Lemoine A, Finkelstein DM, Kawasaki H, Fujii T, Chung RT, Lauwers GY, Kulu Y, Muzikansky A, Kuruppu D, Lanuti M, Goodwin JM, Azoulay D, Fuchs BC. Epidermal growth factor gene functional polymorphism and the risk of hepatocellular carcinoma in patients with cirrhosis. JAMA. 2008 Jan 2;299(1):53-60. doi: 10.1001/jama.2007.65.
PubMed 18167406Thiery JP, Sleeman JP. Complex networks orchestrate epithelial-mesenchymal transitions. Nat Rev Mol Cell Biol. 2006 Feb;7(2):131-42. doi: 10.1038/nrm1835.
PubMed 16493418Okumoto K, Hattori E, Tamura K, Kiso S, Watanabe H, Saito K, Saito T, Togashi H, Kawata S. Possible contribution of circulating transforming growth factor-beta1 to immunity and prognosis in unresectable hepatocellular carcinoma. Liver Int. 2004 Feb;24(1):21-8. doi: 10.1111/j.1478-3231.2004.00882.x.
PubMed 15101997Zulehner G, Mikula M, Schneller D, van Zijl F, Huber H, Sieghart W, Grasl-Kraupp B, Waldhor T, Peck-Radosavljevic M, Beug H, Mikulits W. Nuclear beta-catenin induces an early liver progenitor phenotype in hepatocellular carcinoma and promotes tumor recurrence. Am J Pathol. 2010 Jan;176(1):472-81. doi: 10.2353/ajpath.2010.090300. Epub 2009 Dec 11.
PubMed 20008139
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
- ClinicalTrials.gov ID
- NCT03203837
- Acronym / sponsor ID
- STU000201854
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Radioembolization, Y90, TheraSphere, HCC, Biomarker, Prognostic factor, Angiogenesis, Inflammatory
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding Discontinued due to low accrual rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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 analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.
Detailed description
Patients who have planned lobar radioembolization (TheraSphere (TS)) and consent to this study will have peripheral blood samples collected pre-TS, post-TS, 4 hours post-TS, 24 hours post-TS, 3 days post-TS, 7 days post-TS and 30 days post-TS to analyze specific angiogenic, inflammatory and immune profiles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Other: Plasma collectionHCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hepatocellular carcinoma who will be receiving lobar TheraSphere radioembolization.
Key inclusion criteria (9 listed)
- Must have the diagnosis of HCC (biopsy or imaging criteria)
- Must have planned lobar TheraSphere treatment
- Must be able to give consent
- Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
- Must have a life expectancy of ≥ 3 months
Key exclusion criteria (1 listed)
- Patients are excluded if they do not meet the inclusion criteria
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 |
|---|---|---|
| Plasma collectionWe will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization. | Other | HCC patients |
Primary outcome
Percentage change in angiogenic, inflammatory and immune biomarkers
Time frame: 2 years
The percent of change at 7 different timepoints for the following biomarkers will be calculated: Ang-2, FGFb, HB-EGF, HGF, PDGF-BB, PIGF, SDF-1, VEGF, VEGFC, IFNg, IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, TNFa trimer, CRP, TGFb1, EGFR, PD-1, PD-L1, CD45RA, CD127, HLA-DR, CD62L, CD3, CD8, CD197, CCR7, CD45RO, PD-L2, FOXP3, Perforin, Granzyme, TIA-1, CD14, CD107a, CD25, CD45, CD4, CD20 and CD56+16.
4 secondary outcomes
Treatment Response- AFP
Time frame: 2 years
Treatment Response - Imaging
Time frame: 2 years
Treatment Response- Time-to-Progression
Time frame: 2 years
Treatment Response- Overall Survival
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Funding Discontinued due to low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 11176129Poon RT, Ng IO, Lau C, Zhu LX, Yu WC, Lo CM, Fan ST, Wong J. Serum vascular endothelial growth factor predicts venous invasion in hepatocellular carcinoma: a prospective study. Ann Surg. 2001 Feb;233(2):227-35. doi: 10.1097/00000658-200102000-00012.
- Background: PubMed 8625069Ng IO, Lai EC, Fan ST, Ng MM, So MK. Prognostic significance of pathologic features of hepatocellular carcinoma. A multivariate analysis of 278 patients. Cancer. 1995 Dec 15;76(12):2443-8. doi: 10.1002/1097-0142(19951215)76:123.0.co;2-f.
- Background: PubMed 1511446Finkenzeller G, Marme D, Weich HA, Hug H. Platelet-derived growth factor-induced transcription of the vascular endothelial growth factor gene is mediated by protein kinase C. Cancer Res. 1992 Sep 1;52(17):4821-3.
- Background: PubMed 7843420Stavri GT, Hong Y, Zachary IC, Breier G, Baskerville PA, Yla-Herttuala S, Risau W, Martin JF, Erusalimsky JD. Hypoxia and platelet-derived growth factor-BB synergistically upregulate the expression of vascular endothelial growth factor in vascular smooth muscle cells. FEBS Lett. 1995 Jan 30;358(3):311-5. doi: 10.1016/0014-5793(94)01458-d.
- Background: PubMed 17291746Mann CD, Neal CP, Garcea G, Manson MM, Dennison AR, Berry DP. Prognostic molecular markers in hepatocellular carcinoma: a systematic review. Eur J Cancer. 2007 Apr;43(6):979-92. doi: 10.1016/j.ejca.2007.01.004. Epub 2007 Feb 8.
- Background: PubMed 16629644Wada H, Nagano H, Yamamoto H, Yang Y, Kondo M, Ota H, Nakamura M, Yoshioka S, Kato H, Damdinsuren B, Tang D, Marubashi S, Miyamoto A, Takeda Y, Umeshita K, Nakamori S, Sakon M, Dono K, Wakasa K, Monden M. Expression pattern of angiogenic factors and prognosis after hepatic resection in hepatocellular carcinoma: importance of angiopoietin-2 and hypoxia-induced factor-1 alpha. Liver Int. 2006 May;26(4):414-23. doi: 10.1111/j.1478-3231.2006.01243.x.
- Background: PubMed 23162604Bassullu N, Turkmen I, Dayangac M, Yagiz Korkmaz P, Yasar R, Akyildiz M, Yaprak O, Tokat Y, Yuzer Y, Bulbul Dogusoy G. The Predictive and Prognostic Significance of c-erb-B2, EGFR, PTEN, mTOR, PI3K, p27, and ERCC1 Expression in Hepatocellular Carcinoma. Hepat Mon. 2012 Oct;12(10 HCC):e7492. doi: 10.5812/hepatmon.7492. Epub 2012 Oct 11.
- Background: PubMed 11355950Ito Y, Takeda T, Sakon M, Tsujimoto M, Higashiyama S, Noda K, Miyoshi E, Monden M, Matsuura N. Expression and clinical significance of erb-B receptor family in hepatocellular carcinoma. Br J Cancer. 2001 May 18;84(10):1377-83. doi: 10.1054/bjoc.2000.1580.
- Background: PubMed 10374394Tang Z, Qin L, Wang X, Zhou G, Liao Y, Weng Y, Jiang X, Lin Z, Liu K, Ye S. Alterations of oncogenes, tumor suppressor genes and growth factors in hepatocellular carcinoma: with relation to tumor size and invasiveness. Chin Med J (Engl). 1998 Apr;111(4):313-8.
- Background: PubMed 12846405Altimari A, Fiorentino M, Gabusi E, Gruppioni E, Corti B, D'Errico A, Grigioni WF. Investigation of ErbB1 and ErbB2 expression for therapeutic targeting in primary liver tumours. Dig Liver Dis. 2003 May;35(5):332-8. doi: 10.1016/s1590-8658(03)00077-x.
- Background: PubMed 17380077Lee TY, Kim KT, Han SY. Expression of ErbB receptor proteins and TGF-alpha during diethylnitrosamine-induced hepatocarcinogenesis in the rat liver. Korean J Hepatol. 2007 Mar;13(1):70-80.
- Background: PubMed 18167406Tanabe KK, Lemoine A, Finkelstein DM, Kawasaki H, Fujii T, Chung RT, Lauwers GY, Kulu Y, Muzikansky A, Kuruppu D, Lanuti M, Goodwin JM, Azoulay D, Fuchs BC. Epidermal growth factor gene functional polymorphism and the risk of hepatocellular carcinoma in patients with cirrhosis. JAMA. 2008 Jan 2;299(1):53-60. doi: 10.1001/jama.2007.65.
- Immunotherapy and Hepatocellular Carcinoma EditorialLink provided by the sponsor.
- 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.
Robert Lewandowski, MD principal investigator
Northwestern University
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 Carcinoma, run by Northwestern University 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 9 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 9 Sep 2020. 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: Funding Discontinued due to low accrual rate). 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?
Percentage change in angiogenic, inflammatory and immune biomarkers (time frame: 2 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 NCT03203837, which also lists 29 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 9 Sep 2020.