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Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

21 maj 2021 uppdaterad av: Tianjin Medical University Cancer Institute and Hospital

A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.

The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.

Studietyp

Interventionell

Inskrivning (Förväntat)

39

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Tianjin
      • Tianjin, Tianjin, Kina, 300000
        • Rekrytering
        • Tianjin Medical University Cancer Institute and Hospital
        • Kontakt:
        • Kontakt:
          • chuntao Gao, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
  • Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
  • ECOG score 0-2
  • Adequate organ and bone marrow function
  • The expected survival time is ≥ 12 weeks
  • Had normal swallowing function, without dysfunction of gastrointestinal absorption
  • Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures

Exclusion Criteria:

  • The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
  • The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
  • Known to be allergic to the active ingredients or excipients in this study.
  • Had other active malignant tumors within 5 years before entering the study.
  • Subject with cerebral metastasis
  • Have a clear history of serious and uncontrolled other disease or mental disorders;
  • Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
  • Other situations that the researcher considers inappropriate to participate in the research.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: SHR-1020 combined with albumin-bound paclitaxel
Läkemedel: SHR-1020+albumin-bound paclitaxel
SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer
Andra namn:
  • Nab-paclitaxel， Paclitaxel-albumin

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ORR (Objective Response Rate)
Tidsram: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DCR (Disease Control Rate)
Tidsram: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
PFS (Progression-Free-Survival)
Tidsram: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
6mPFS
Tidsram: Up to 6 months
6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Up to 6 months
OS (overall survival)
Tidsram: From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
From date of treatment start to any cause death or last follow-up.
From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
Adverse events (per CTCAE v5.0 criteria)
Tidsram: Up to 12months
To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel
Up to 12months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 april 2021

Primärt slutförande (Förväntat)

1 juli 2023

Avslutad studie (Förväntat)

1 juli 2023

Studieregistreringsdatum

Först inskickad

17 mars 2021

Först inskickad som uppfyllde QC-kriterierna

22 mars 2021

Första postat (Faktisk)

24 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 maj 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 maj 2021

Senast verifierad

1 december 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PANC-2nd-IIT-FMTN-naP

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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