- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03376191
Apatinib in Advanced Non-squamous,NSCLC
Prospective, Multicenter, Non-intervention Clinical Trial of Apatinib in the Treatment of Advanced Non-squamous,Non-small Cell Lung Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a multi-center, non-interventional clinical study. The number of patients that planned to be recruited is: from May 2017 to April 2019, the actual number of cases recruited into this study.
If the clinicians thought the patient is suitable to take apatinib treatment, and give the patient apatinib treatment, the patient can be recruited into this study. Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication. The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop.
During the course of the study, the researchers will not intervene the treatment of the patients, but only record the efficacy and adverse reactions.
Main evaluation criteria: PFS Secondary evaluation criteria: OS,DCR and ORR (according to RECIST1.1). Main safety indicators:AE, SAE (according to NCI CTCAE V4.0) and QOL scores (Quality of Life Questionnaire-lung cancer).
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age: ≥ 18 years old;
- Histologically or cytologically confirmed, locally advanced or stage IV non-squamous, non-small cell lung cancer;
- Regardless of the past anti-tumor treatments (no limited to the number of past treatment lines), the doctors believe that apatinib can bring benefits to patients;
- The patient is voluntarily to join the study, and signed informed consent, good compliance, with follow-up.
Exclusion Criteria:
If any of the following criteria is met, the subject shall be excluded:
- Squamous cell carcinoma and/or small cell lung cancer patients;
- There are contraindications to apatinib (active bleeding, thrombosis, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency, major surgery within 30 days, severe liver and kidney dysfunction, etc.);
- Allergic to apatinib and / or its excipients;
- Pregnant or lactating women;
- According to the researcher's judgment, there are other situations that may increase the risk associated with participating in this study or the drug, which may lead to patients not being eligible for enrollment in the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
PFS (Progression-Free survival)
Tidsramme: From the date Into this study (signed ICF) to tumor progression or death for any reason,whichever came first, assessed up to 36 months
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From the date Into this study (signed ICF) to tumor progression or death for any reason.
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From the date Into this study (signed ICF) to tumor progression or death for any reason,whichever came first, assessed up to 36 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
OS (Overall survival)
Tidsramme: From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months.
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From the date Into this study (signed ICF) to death for any reason.
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From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months.
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DCR (Disease control rate)
Tidsramme: From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.
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The rate of CR, PR plus SD
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From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.
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ORR (objektiv kontrolhastighed)
Tidsramme: Fra datoen Ind i denne undersøgelse (signeret ICF) til tumorprogression, vurderet op til 36 måneder.
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Satsen for CR og PR
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Fra datoen Ind i denne undersøgelse (signeret ICF) til tumorprogression, vurderet op til 36 måneder.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
AE (Adverse events)
Tidsramme: From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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AE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).
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From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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SAE (Severe adverse events)
Tidsramme: From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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SAE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).
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From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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QOL scores
Tidsramme: From the date Into this study (signed ICF) to tumor progression, exit this research, or death,whichever came first, assessed up to 36 months.
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Quality of life scores
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From the date Into this study (signed ICF) to tumor progression, exit this research, or death,whichever came first, assessed up to 36 months.
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
- Didkowska J, Wojciechowska U, Manczuk M, Lobaszewski J. Lung cancer epidemiology: contemporary and future challenges worldwide. Ann Transl Med. 2016 Apr;4(8):150. doi: 10.21037/atm.2016.03.11.
- Hall RD, Le TM, Haggstrom DE, Gentzler RD. Angiogenesis inhibition as a therapeutic strategy in non-small cell lung cancer (NSCLC). Transl Lung Cancer Res. 2015 Oct;4(5):515-23. doi: 10.3978/j.issn.2218-6751.2015.06.09.
- Zhang H. Apatinib for molecular targeted therapy in tumor. Drug Des Devel Ther. 2015 Nov 13;9:6075-81. doi: 10.2147/DDDT.S97235. eCollection 2015.
- Fontanella C, Ongaro E, Bolzonello S, Guardascione M, Fasola G, Aprile G. Clinical advances in the development of novel VEGFR2 inhibitors. Ann Transl Med. 2014 Dec;2(12):123. doi: 10.3978/j.issn.2305-5839.2014.08.14.
- Zhang L, Shi M, Huang C et al. A phase II, multicenter, placebo-controlled trial of apatinib in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after two previous treatment regimens. J Clin Oncol 2012; 30: Abst 7548.
- Mi YJ, Liang YJ, Huang HB, Zhao HY, Wu CP, Wang F, Tao LY, Zhang CZ, Dai CL, Tiwari AK, Ma XX, To KK, Ambudkar SV, Chen ZS, Fu LW. Apatinib (YN968D1) reverses multidrug resistance by inhibiting the efflux function of multiple ATP-binding cassette transporters. Cancer Res. 2010 Oct 15;70(20):7981-91. doi: 10.1158/0008-5472.CAN-10-0111. Epub 2010 Sep 28.
- Ding L, Li QJ, You KY, Jiang ZM, Yao HR. The Use of Apatinib in Treating Nonsmall-Cell Lung Cancer: Case Report and Review of Literature. Medicine (Baltimore). 2016 May;95(20):e3598. doi: 10.1097/MD.0000000000003598.
- Fan M, Zhang J, Wang Z, Wang B, Zhang Q, Zheng C, Li T, Ni C, Wu Z, Shao Z, Hu X. Phosphorylated VEGFR2 and hypertension: potential biomarkers to indicate VEGF-dependency of advanced breast cancer in anti-angiogenic therapy. Breast Cancer Res Treat. 2014 Jan;143(1):141-51. doi: 10.1007/s10549-013-2793-6. Epub 2013 Dec 1.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Apatinib
Andre undersøgelses-id-numre
- APTN-NIS-NSCLC-BCH
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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