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Undersøgelse af Paclitaxel Protein Bundet + Gemcitabin + Cisplatin + Hydrochloroquin som behandling ved ubehandlet bugspytkirtelkræft

23. juni 2026 opdateret af: HonorHealth Research Institute

Et fase II-studie af Paclitaxel-proteinbundet + Gemcitabin + Cisplatin+ Hydroxychlororoquin som præoperativ behandling hos patienter med ubehandlet resektabelt, borderline-resektabelt og lokalt avanceret adenokarcinom i bugspytkirtlen

At evaluere normaliseringshastigheden for CA 19-9 hos personer med ikke-metastatisk bugspytkirtelcancer efter op til 6 måneders neoadjuverende kemoterapi.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
        • HonorHealth Research Institute

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

Beskrivelse

Inklusionskriterier:

  • Patienten har histologisk eller cytologisk bekræftet resektabel, borderline resektabel eller lokalt fremskreden (ikke-opererbar) PDAC (baseret på Tempero et al 2016)
  • Alder ≥ 18 år.
  • Hvis en kvindelig patient er i den fødedygtige alder, skal hun have en negativ serumgraviditetstest (≥β-hCG) dokumenteret inden for 72 timer efter den første administration af forsøgslægemidlet
  • Hvis den er seksuelt aktiv, skal patienten og partneren acceptere at bruge prævention, som efterforskeren anser for tilstrækkelig og passende
  • Patienten må ikke have modtaget tidligere kemoterapi eller strålebehandling for PDAC
  • Patienter skal have normal organ- og marvfunktion
  • Patienten har acceptabel koagulationsstatus som angivet ved en INR ≤ 1,5 x ULN. Patienter på antikoagulering kan inkluderes efter investigatorens skøn.
  • Karnofsky Performance Status (KPS) på ≥70 %.
  • Har en forhøjet CA 19-9 (>2X ULN) i sammenhæng med normalt bilirubin

Ekskluderingskriterier:

  • Patienten vil blive udelukket fra denne undersøgelse, hvis et af følgende kriterier gælder: Bevis på metastatisk sygdom. Ingen metastatisk sygdom defineret som en eller flere af følgende; Mistænkelig lymfadenopati uden for det standardkirurgiske område (dvs. aortokavalknuder, fjerne abdominale knuder) eller radiografisk bevis for metastatisk sygdom i fjerne organer, peritoneum eller ascites
  • Aktiv, ukontrolleret bakteriel, viral eller svampeinfektion(er), der kræver systemisk terapi.
  • Kendt infektion med HIV, hepatitis B eller hepatitis C.
  • Har gennemgået en større operation, bortset fra diagnostisk kirurgi (dvs. - operation udført for at få en biopsi til diagnose uden fjernelse af et organ), inden for 4 uger før dag 1 af behandlingen i denne undersøgelse.
  • Anamnese med allergi eller overfølsomhed over for undersøgelseslægemidlerne.
  • Alvorlige medicinske risikofaktorer, der involverer et hvilket som helst af de større organsystemer, således at efterforskeren anser det for usikkert for patienten at modtage et eksperimentelt forskningslægemiddel.
  • Aktuelle, alvorlige, klinisk signifikante hjertearytmier som bestemt af investigator.
  • Patienten er uvillig eller ude af stand til at overholde undersøgelsesprocedurerne.
  • Patienten er tilmeldt et industrisponsoreret klinisk forsøg, der involverer behandling med undersøgelsesterapi. Patienter, der er tilmeldt HonorHealth-sponsorerede forskningsundersøgelser, kan være berettigede til at deltage, så længe deres deltagelse i de andre forskningsundersøgelser ikke forstyrrer de indsamlede data til denne undersøgelse.
  • Patient med en anamnese med interstitiel lungesygdom, historie med langsomt fremadskridende dyspnø og uproduktiv hoste, sarkoidose, silikose, idiopatisk lungefibrose, pulmonal overfølsomhedspneumonitis eller multiple allergier.
  • Brug af cannabinoider, der ikke er godkendt af FDA, er forbudt. Total daglig brug på op til 40 mg per dag af marinol er acceptabel.

Udelukkelseskriterier kun for hydroxychloroquin-udvidelseskohorte:

  • Forlænget QTcF > 450 ms for mænd og > 470 ms for kvinder ved screening. Elektrolyt ubalancer (f.eks. hypokaliæmi/hypomagnesæmi/hypocalcæmi) skal korrigeres før første dosis hydroxychloroquin.
  • Kendt anden eller tredje grads atrioventrikulær blokering.
  • Patienten tager samtidig medicin, der har "kendt" risiko for QT-forlængelse eller torsdades de pointe.
  • Patienten har allerede eksisterende retinopati.
  • Patienten har kendt overfølsomhed over for hydroxychloroquin eller andre 4-aminoquinolinforbindelser.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Behandling
Paclitaxel Proteinbundet + Gemcitabin + Cisplatin + Hydrochloroquin
Medicin: Cisplatin
kombinationsterapi
Medicin: Gemcitabin
kombinationsterapi
Medicin: Paclitaxel protein bundet
kombinationsterapi
Medicin: Hydroxychloroquin
kombinationsterapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CA 19-9 Normalization
Tidsramme: From enrollment to the end of study, up to 30 weeks.
Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured.
From enrollment to the end of study, up to 30 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resectability Rate (R0)
Tidsramme: After end of treatment, from 6 months up to 2 years.
The percentage of participants whose tumors could be completely removed by surgery after receiving study regimen with no cancer cells left at margins (R0).
After end of treatment, from 6 months up to 2 years.
Pathologic Complete Response Rate (pCR)
Tidsramme: After end of treatment, from 6 months up to 2 years.
Pathological complete response rate (pCR) is defined here as the absence of detectable cancer after surgical resection. Participants received a CT/MRI scan after surgical resection to monitor response using RECIST 1.1 criteria.
After end of treatment, from 6 months up to 2 years.
Radiological Response - Complete Response (CR) or Partial Response (PR)
Tidsramme: From enrollment to end of study, up to 30 weeks.
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; >30% decrease in tumor size).
From enrollment to end of study, up to 30 weeks.
Radiological Response - All Responses
Tidsramme: From enrollment to the end of study, up to 30 weeks.
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; >30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; >20% increase in tumor size or new lesions).
From enrollment to the end of study, up to 30 weeks.
2-Year Survival
Tidsramme: 2 years after study completion
Participants were contacted by telephone every 12 weeks to monitor survival until date of death. Participants surviving up to 2 years are reported.
2 years after study completion
Overall Survival
Tidsramme: Every 12 weeks from study entry, up to 32 months.
Participants were contacted by telephone every 12 weeks to monitor survival until date of death.
Every 12 weeks from study entry, up to 32 months.
Adverse Events Related to Study Agents
Tidsramme: From enrollment to end of study, up to 30 weeks.

The number of patients who experienced an adverse event (AE) determined to be related to one or more of the study agents. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline:

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling.

Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
From enrollment to end of study, up to 30 weeks.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score
Tidsramme: From enrollment to end of study, up to 30 weeks.

The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain severity was assessed with a scale range of 0-10, 0=no pain, 10=worst imaginable. Multiple question results were combined into a single pain severity score per patient on the 0-10 scale range.

Data is presented as the median of baseline scores ("Baseline") (n=11), median of end of treatment (EOT) scores ("End of Treatment (EOT)") (n=11), and median of within-subject change scores calculated as EOT minus baseline scores ("Change Between Baseline and EOT") (n=11).
From enrollment to end of study, up to 30 weeks.
Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score
Tidsramme: From enrollment to end of study, up to 30 weeks.

The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain interference was assessed with a scale range of 0-10, 0=does not interfere, 10=completely interferes. Multiple question results were combined into a single pain interference score per patient on the 0-10 scale range.

Data is presented as the median of baseline scores ("Baseline") (n=11), median of end of treatment (EOT) scores ("End of Treatment (EOT)") (n=11), and median of within-subject change scores calculated as EOT minus baseline scores ("Change Between Baseline and EOT") (n=11).
From enrollment to end of study, up to 30 weeks.
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score
Tidsramme: From enrollment to end of study, up to 30 weeks.

The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Core symptom severity within the last 24 hours was assessed with a scale range of 0-10, 0=not present, 10=worst imaginable. The reported severity of multiple symptoms was combined into a single overall symptom severity score for each patient on the 0-10 scale range.

Data is presented as the median of baseline scores ("Baseline") (n=11), median of end of treatment (EOT) scores ("End of Treatment (EOT)") (n=11), and median of within-subject change scores calculated as EOT minus baseline scores ("Change Between Baseline and EOT") (n=11).
From enrollment to end of study, up to 30 weeks.
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), GI Module Score
Tidsramme: From enrollment to end of study, up to 30 weeks.

The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. The GI module asks specific questions related to GI symptoms and asks users to rank the severity of symptoms using a 0-10 scale, 0=not present, 10=worst imaginable. The reported severity of multiple GI symptoms was combined into a single GI module score for each patient on the 0-10 scale range.

Data is presented as the median of baseline scores ("Baseline") (n=11), median of end of treatment (EOT) scores ("End of Treatment (EOT)") (n=11), and median of within-subject change scores calculated as EOT minus baseline scores ("Change Between Baseline and EOT") (n=11).
From enrollment to end of study, up to 30 weeks.
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Overall Symptom Interference With Daily Life Score
Tidsramme: From enrollment to end of study, up to 30 weeks.

The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Symptom interference with daily life activities within the last 24 hours was measured using a 0-10 scale, 0=does not interfere, 10=interferes completely. The reported interference for multiple daily activities was combined into a single symptom interference score for each patient on the 0-10 scale range.

Data is presented as the median of baseline scores ("Baseline") (n=11), median of end of treatment (EOT) scores ("End of Treatment (EOT)") (n=11), and median of within-subject change scores calculated as EOT minus baseline scores ("Change Between Baseline and EOT") (n=11).
From enrollment to end of study, up to 30 weeks.

Samarbejdspartnere og efterforskere

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

Sponsor

HonorHealth Research Institute

Efterforskere

  • Ledende efterforsker: Erkut Borazanci, MD, HonorHealth Research Institute

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)

1. december 2020

Primær færdiggørelse (Faktiske)

21. februar 2024

Studieafslutning (Faktiske)

31. juli 2025

Datoer for studieregistrering

Først indsendt

1. december 2020

Først indsendt, der opfyldte QC-kriterier

14. december 2020

Først opslået (Faktiske)

16. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HCQ NABPLAGEM-NEO 2020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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