- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03224221
Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
19. juli 2017 opdateret af: The First Affiliated Hospital of Anhui Medical University
We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Esophageal cancer is one of the most common malignant tumor and esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma in China.
Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor.
New treatments were needed.
Apatinib, which was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer, is a small molecule tyrosine kinase inhibitor.
It competes with intracellular VEGFR-2's ATP binding sites highly and selectively, thereby blocking downstream signaling to achieve the goal of inhibiting neovascularization in tumor tissue.
We have observed in clinical practice that some patients with esophageal squamous cell carcinoma have benefited from the treatment of apatinib.
So we conduct a phase II clinical trial to explore the efficacy and safety of Apatinib combined with chemotherapy (platinum and fluorouracil) in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
189
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Anhui
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Hefei, Anhui, Kina, 230000
- Rekruttering
- First Affiliated Hospital of Anhui Medical University
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Kontakt:
- Guoping Sun
- Telefonnummer: 0551-62922249
- E-mail: gpsun_ahmu@126.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
Beskrivelse
Inclusion Criteria:
- 1.Male or female patients, age:≥18 years old.
- 2.Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
- 3.Patients who undergo local or recurrent metastases after surgery and / or radiotherapy and chemotherapy,at least one measurable lesion(tumor lesions CT scan length ≥ 10 mm,lymph node lesions CT scan short diameter ≥ 15 mm,scan layer thickness is not greater than 6 mm).
- 4.The ECOG physical status score: 0 to 2.
- 5.Expected survival ≥ 3 months.
- 6.Subjects received other treatment damage have been restored, which received nitroso or mitomycin interval ≥ 6 weeks; to accept other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
7.The main organs function properly:
blood routine examination standards to be met (14 days without blood transfusion and blood products):
- HB≥90g/L;
- ANC≥1.5×109/L;
- PLT≥80×109/L;
biochemical tests to meet the following criteria:
- TBIL<1.5×ULN;
- ALT and AST<2.5×ULN, and <5×ULN for patients with liver metastases
- Serum Cr≤1.5×ULN or endogenous creatinine clearance> 45ml/min (Cockcroft-Gault formula);
- 8.The women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use the appropriate method at 8 weeks after the trial and the last given test contraception.For the man, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given;
- 9.Patients should be voluntary to the trial and provide with signed informed consent
Exclusion Criteria:
- 1.Pregnant or lactating women;
- 2.Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with myocardial infarction or myocardial infarction, arrhythmia and grade II heart Incomplete function;
- 3.Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction;
- 4.Coagulation dysfunction(INR>1.5 or prothrombin time (PT)>ULN + 4 seconds or APTT>1.5×ULN),with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- 5.with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding;
- 6.Central nervous system metastasis with symptoms;
- 7.The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Apatinib with Chemotherapy
Apatinib with Chemotherapy(Fluorouracil and platinum),patients will receive Apatinib at 500mg/times,oral one times daily for 28 days.the
dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
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Patients will receive Apatinib at 500mg/times,oral one times daily for 28 days
the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
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|
Aktiv komparator: Chemotherapy
Chemotherapy (Fluorouracil and platinum),the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients.
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the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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One-year survival rate
Tidsramme: 12 months
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The probability of survival in one year
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Samlet overlevelse
Tidsramme: Fra randomiseringsdatoen til datoen for første dokumenterede progression eller dødsdato uanset årsag, alt efter hvad der kom først, vurderet op til 100 måneder
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Fra randomiseringsdatoen til datoen for første dokumenterede progression eller dødsdato uanset årsag, alt efter hvad der kom først, vurderet op til 100 måneder
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Progress free survival(PFS)
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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|
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Incidence of Treatment-Emergent Adverse Events
Tidsramme: Each follow up visit, assessed up to 12 months
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Safety evaluation according to the CTCAE4.0
standard, once every 1 cycle assessment
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Each follow up visit, assessed up to 12 months
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Quality of life using EORTC QLQ C30 - scale
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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Life quality evaluation using EORTC QLQ C30 - scale,once every 1 cycle assessment
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
23. marts 2017
Primær færdiggørelse (Forventet)
23. januar 2019
Studieafslutning (Forventet)
23. juni 2019
Datoer for studieregistrering
Først indsendt
19. juli 2017
Først indsendt, der opfyldte QC-kriterier
19. juli 2017
Først opslået (Faktiske)
21. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juli 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Esophageale neoplasmer
- Karcinom, pladecelle
- Esophageal pladecellekarcinom
- Neoplasmer, pladecelle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Proteinkinasehæmmere
- Fluorouracil
- Apatinib
Andre undersøgelses-id-numre
- AHAT-103
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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