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Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

19. juni 2017 opdateret af: FanQingxia, The First Affiliated Hospital of Zhengzhou University

A Prospective, Open-label, Randomized Controlled Clinical Study of Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

Esophageal cancer is a common malignant tumor in china, occupies the second place of malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • Henan
      • Zhengzhou, Henan, Kina, 450000

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age: 18 years old to 75 years old, male and female is ok.
  • Esophageal squamous cell carcinoma diagnosed by histopathology and immunohistochemistry. At least one treated measurable lesion (spiral CT scan length ≥10mm, in line with RESCIST version 1.1 standard requirements);
  • Patients with advanced esophageal cancer treated by radiotherapy and treatment;
  • ECOG PS Rating: 0-1 points;
  • Expected survival ≥12 weeks;
  • Without molecular targeted drug therapy.
  • The main organ function is normal, that is to meet the following criteria:

Blood test:a.HB≥90 g/L;b.ANC≥1.5×109/L;c.PLT ≥80×109/L; Biochemical tests:a.ALB≥30g / L;b. ALT和AST<2ULN;ALT and AST <2ULN;c.TBIL≤1.5ULN;Plasma Cr ≤ 1.5ULN;

  • Subjects volunteered to join the study, signed informed consent, compliance, with follow-up.
  • Researchers believe that patients can benefit.

Exclusion Criteria:

  • Patients who have been confirmed to be allergic to apatinib and / or its excipients;
  • Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy), with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
  • Patients with a clear tendency to gastrointestinal bleeding, including the following: localized ulcer lesions, and fecal occult blood (++) can not be grouped; 2 months with black, hematemesis history;
  • Coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), with bleeding tendency;
  • (Eg, no swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) that affect the absorption of oral medications;
  • The patients with active brain metastases(without medical control) , cancer meningitis, spinal cord compression, or screening of imaging CT or MRI examination found that the brain or pia mater disease (21 days before the completion of treatment and symptoms of stable brain Metastasis patients can be grouped, but the need for transcranial MRI, CT or intravenous angiography, confirmed as no cerebral hemorrhage symptoms)
  • Pregnant or lactating women
  • Subject with other malignancies within 5 years(except the skin basal cell carcinoma and cervical in situ cancer that have already cured )
  • Subject with a history of psychiatric abuse and who can not be abused or have mental disorders;
  • Subject who participated in other drug clinical trials within 4 weeks.
  • Subject who have received VEGFR inhibitors such as sorafenib, sunitinib;
  • According to the investigator's judgment, there are serious illnesses that compromise the patient's safety or affect the patient's completion of the study;
  • Researchers think it is not suitable for inclusion.

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
Eksperimentel: Apatinib
Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .
Andre navne:
  • Docetaxel
Aktiv komparator: docetaxel
Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .
Andre navne:
  • Docetaxel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 6 months
The first day of treatment to the date that disease progression is reported.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Survival (OS)
Tidsramme: up to 24 months
the first day of treatment to death or last survival confirm date
up to 24 months

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)

1. oktober 2016

Primær færdiggørelse (Forventet)

30. december 2018

Studieafslutning (Forventet)

30. december 2019

Datoer for studieregistrering

Først indsendt

17. juni 2017

Først indsendt, der opfyldte QC-kriterier

19. juni 2017

Først opslået (Faktiske)

20. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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