NCT02786342

Brief Summary

Sorafenib represents the standard care for advanced hepatocellular carcinoma (HCC). However, molecular predictors of sorafenib efficacy have not yet been identified. The primary aim of the study is to validate the prognostic or predictive role of eNOS,Ang2, HIF-1, VEGF and VEGFR polymorphisms in relation to clinical outcome (progression-free survival, PFS) of HCC patients treated with sorafenib.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5.3 years

First QC Date

May 20, 2016

Last Update Submit

February 25, 2021

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaSorafenibHCCAngiogenesisPolymorphisms

Outcome Measures

Primary Outcomes (1)

  • PFS

    prognostic/predictive role of eNOS,Ang2, HIF-1, VEGF and VEGFR polymorphisms in relation to Progression Free Survival

    up to three years

Secondary Outcomes (1)

  • OS

    up to three years

Study Arms (1)

Advanced HCC patients treated with sorafenib

Procedure: blood sample collection

Interventions

blood sample collectionPROCEDURE
Advanced HCC patients treated with sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of patients with advanced-stage hepatocellular carcinoma, according to the criteria American Association for the Study of Liver Disease (AASLD) / European Association for the Study of the Liver (EASL)

You may qualify if:

  • Signed and dated informed consent.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Male or Female, aged \>18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
  • Life expectancy of 12 weeks or more.
  • Adequate hematologic function.
  • Patients were required to have at least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
  • Concomitant antiviral systemic therapy was allowed.
  • Resolution of all acute toxic effects of any prior local treatment.
  • HCC diagnosed according to the AASLD and/or EASL criteria.

You may not qualify if:

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC.
  • Renal failure requiring hemo- or peritoneal dialysis.
  • Presence of recent (\< 6 months) or current cardiac failure Known history of human immunodeficiency virus (HIV) infection.
  • Known central nervous system tumors including metastatic brain disease.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Any prior local therapy within 4 weeks of study entry.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

IRCCS Istituto Tumori Giovanni Paolo II

Bari, BA, 70124, Italy

Location

AOU di Cagliari - PO San Giovanni di Dio

Cagliari, CA, 09124, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, FC, 47014, Italy

Location

Istituto Oncologico Veneto

Padua, PD, 35128, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, PI, 56126, Italy

Location

Oncologia medica - AOU di Parma

Parma, PR, 43126, Italy

Location

Oncologia medica , PO FAENZA, Ausl della Romagna

Faenza, RA, 48018, Italy

Location

Ospedale Civile degli Infermi

Rimini, RM, 47921, Italy

Location

Azienda Sanitaria Universitaria Integrata di Udine S. Maria della Misericordia

Udine, UD, 33100, Italy

Location

policlinico universitario Campus Bio-medico

Roma, 00128, Italy

Location

Related Publications (3)

  • Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

    PMID: 18650514BACKGROUND

  • Scartozzi M, Faloppi L, Svegliati Baroni G, Loretelli C, Piscaglia F, Iavarone M, Toniutto P, Fava G, De Minicis S, Mandolesi A, Bianconi M, Giampieri R, Granito A, Facchetti F, Bitetto D, Marinelli S, Venerandi L, Vavassori S, Gemini S, D'Errico A, Colombo M, Bolondi L, Bearzi I, Benedetti A, Cascinu S. VEGF and VEGFR genotyping in the prediction of clinical outcome for HCC patients receiving sorafenib: the ALICE-1 study. Int J Cancer. 2014 Sep 1;135(5):1247-56. doi: 10.1002/ijc.28772. Epub 2014 Feb 20.

    PMID: 24510746BACKGROUND

  • Casadei-Gardini A, Marisi G, Dadduzio V, Gramantieri L, Faloppi L, Ulivi P, Foschi FG, Tamburini E, Vivaldi C, Rizzato MD, Ielasi L, Canale M, Conti F, Rudnas B, Fornaro L, Silvestris N, Silletta M, Cardellino GG, Lonardi S, Fornari F, Orsi G, Rovesti G, Zagonel V, Cascinu S, Scartozzi M. Association of NOS3 and ANGPT2 Gene Polymorphisms with Survival in Patients with Hepatocellular Carcinoma Receiving Sorafenib: Results of the Multicenter Prospective INNOVATE Study. Clin Cancer Res. 2020 Sep 1;26(17):4485-4493. doi: 10.1158/1078-0432.CCR-19-3897. Epub 2020 May 5.

    PMID: 32371540DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, plasma and serum samples.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Andrea Casadei-Gardini, MD

    Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 1, 2016

Study Start

February 15, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

IT(10)