- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02668380
An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer (AHEAD-G202)
28. januar 2016 opdateret af: Peking Union Medical College Hospital
This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle.
To evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
In the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mGC).
New evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care.
After failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival.
Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor, Had been approved by the CFDA for the treatment of advanced gastric cancer, However, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer.
Therefore, an Open Label, Prospective, Multicentre, Non-interventional Study could evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100032
- Rekruttering
- Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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Ledende efterforsker:
- Xiao yi Li, Doctor
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Kontakt:
- Lin Zhao, Master
- Telefonnummer: +86(10)69158315
- E-mail: wz20010727@aliyun.com
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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
Ikke-sandsynlighedsprøve
Studiebefolkning
Advanced Metastatic Gastric Cancer
Beskrivelse
Inclusion Criteria:
- 》18 years old
- Advanced Metastatic Gastric Cancer
- The doctor evaluate that patients had benefit from treatment
- The patients signed the written informed consent
Exclusion Criteria:
- Apatinib has been confirmed for allergy sufferers
- Pregnant or lactating women
- Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
- Doctors think doesn't inclusion
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 |
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Apatinib
Apatinib Tablets: 850 mg,po, once daily , 28 days for a cycle
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Adverse Events
Tidsramme: 1 years
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Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
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1 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall survival
Tidsramme: 1 years
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Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.
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1 years
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Progression-free survival
Tidsramme: 8 months
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A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
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8 months
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Objective response rate
Tidsramme: 5 months
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Number of participants who achieve complete response or partial response.
Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.
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5 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Chunmei Bai, MD, Peking Union Medical College Hospital
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.
Generelle publikationer
- Li N, Bai C, Zhang R, Ma L, Ren X, Zhang J, Fu Z, Zhao L. Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer. Transl Oncol. 2021 Feb;14(2):101004. doi: 10.1016/j.tranon.2020.101004. Epub 2020 Dec 28.
- Wang X, Zhang R, Du N, Yang M, Zang A, Liu L, Yu J, Gao J, Zhang J, Fu Z, Ren Y, Ma L, Guo J, Li Q, Li X, Fan Z, Song X, Liu Z, Zhang Y, Li G, Yu Z, Diao J, Jia J, Liang F, Wang H, Sun J, Gao Y, Yang P, Bai C, Ren X, Zhong D. An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202). Ther Adv Med Oncol. 2020 Mar 19;12:1758835920905424. doi: 10.1177/1758835920905424. eCollection 2020.
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
1. september 2015
Primær færdiggørelse (Forventet)
1. marts 2018
Studieafslutning (Forventet)
1. maj 2019
Datoer for studieregistrering
Først indsendt
5. december 2015
Først indsendt, der opfyldte QC-kriterier
28. januar 2016
Først opslået (Skøn)
29. januar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AHEAD-G202
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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