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A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy

12. november 2019 opdateret af: Bristol-Myers Squibb

Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy

A study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

The central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1426

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New Jersey
      • Princeton, New Jersey, Forenede Stater, 08543
        • Bristol Myers Squibb, CORDS Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study cohort will be selected from the Flatiron database according to the inclusion and exclusion criteria.

Participants will be eligible for inclusion in this study if:

  1. Diagnosed with advanced Hepatocellular Carcinoma (aHCC) in the Flatiron database;
  2. Aged 18 years or older at index date; and
  3. Received second or third line nivolumab monotherapy or combination therapy for aHCC.

Participants will be excluded if:

  1. Received clinical study drugs prior to, on, or post the index date;
  2. Have less than 1 month of medical data following and including the index date. Those meeting the inclusion and exclusion criteria will be further stratified by lines of therapy and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score.

Beskrivelse

Inclusion Criteria:

  • Adult aHCC participants in the Flatiron database as defined by:
  • Diagnosed with HCC International Classification of Diseases (ICD)-9 155.x or ICD-10 C22.x)
  • Pathology consistent with advanced HCC
  • Age 18 years or older at index
  • At least two clinic encounters on different days in the Flatiron database occurring on or after January 1, 2011
  • Participants who received second or third line nivolumab monotherapy or combination therapy for aHCC

Exclusion Criteria:

  • Participants with <1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date
  • Participants with clinical study drug during prior or post study index periods

Other protocol-defined inclusion/exclusion criteria could apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Advanced Hepatocellular Carcinoma (aHCC) cohort
aHCC cohort selected from the Flatiron Health Oncology electronic health record (EHR) data from January 2011 to the most recent data available. The index date will be defined as the start of second or third line nivolumab therapy for aHCC between January 1, 2011 and the most recent data available.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment patterns
Tidsramme: From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)
Nivolumab second and third lines of therapy will be described including prior lines of therapy, duration of nivolumab therapy and time from aHCC diagnosis date to first nivolumab treatment
From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)
Overall Survival
Tidsramme: From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)
The initial second or third line nivolumab therapy date will be used as the start date for the OS analysis. Occurrence of death will be considered as event and the duration for event will be calculated as time from 2L or 3L nivolumab therapy date to death date. Patients who survived will be censored and their duration period will be the time between the initial 2L or 3L nivolumab therapy date and the last date of their post-period follow up
From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. oktober 2018

Primær færdiggørelse (Faktiske)

15. november 2018

Studieafslutning (Faktiske)

19. november 2018

Datoer for studieregistrering

Først indsendt

12. november 2019

Først indsendt, der opfyldte QC-kriterier

12. november 2019

Først opslået (Faktiske)

13. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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