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The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer

25. september 2017 opdateret af: Lin Chen, Chinese PLA General Hospital

The Exploratory Study of Conversion Surgery for Apatinib in Combination With Oxaliplatin/S-1(SOX) for Patients With Unresectable Gastric Cancer

This is a Prospective,Single-center,Single-arm,Open-label exploratory clinical trial evaluating the efficacy and safety of Conversion Surgery for Apatinib plus SOX for patients with unresectable gastric cancer.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Gastric cancer is the second most common cause of cancer-related deaths worldwide, and surgical resection during the early stage has improved treatment outcomes.However, many patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Systemic chemotherapy is the leading treatment that prolongs survival times for such patients.

Approximate 20 patients with unresectable gastric cancer will be enrolled in this study,the investigators will evaluate the efficacy and security of Apatinib + SOX(oxaliplatin+S-1) for unresectable gastric cancer.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

      • Beijing, Kina, 100853
        • Rekruttering
        • The Chinese PLA General Hospital
        • Kontakt:
          • Lin Chen, Master
          • Telefonnummer: 13801290395

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Histologically proved gastric adenocarcinoma;
  2. At least a unresectable factor before operation via CT, MRI, or PET-CT: difficult resection of locally advanced gastric cancer(T4b); hepatic metastasis (H1; at most five lesions, total diameter ≤8 cm); Peritoneal metastasis(CY1, P1) ;
  3. Definitely diagnosed as unresectable gastric cancer via exploratory laparoscopy or laparotomy;
  4. ECOG performance status 0-2;
  5. Age 18-70 years old, Life expectancy estimated than 3 months;
  6. For results of blood routine test and biochemical tests:

    1. Hgb ≥ 80g/L,
    2. WBC ≥ 4000/mm3,
    3. ANC ≥ 1.5×109/L,
    4. platelets ≥ 80×109/L
    5. ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL(Hematogenous metastases),
    6. Serum Total bilirubin ≤ 1.5 X UNL,
    7. Serum Creatine ≤ 1.5 x UNL ;
  7. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;
  8. Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);
  9. informed consent.

Exclusion Criteria:

  1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction; Patients with positive urinary protein;
  2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  3. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
  4. Contraindications include allergy to apatinib and/or its accessories, active bleeding, intestinal perforation, intestinal obstruction, within 30 days after surgery, drugs with poor-controlled hypertension, Class Ⅲ-Ⅳ cardiac dysfunction (NYHA standard), severe hepatic and renal dysfunction(level 4)if apatinib use is considered;
  5. Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed;
  6. Pregnant or lactating women;
  7. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
  8. Treatment with prior radiotherapy, chemotherapy, Targeted therapy or immunotherapy;
  9. Other conditions regimented at investigators' discretion.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Apatinib plus Oxaliplatin/S-1
  1. Apatinib :

    A starting dose of apatinib was administered 500 mg daily on days 1 through 21 of each 3-week cycle.

  2. Oxaliplatin:130 mg/m2,d1,ivgtt,in a 21 day cycle.
  3. S-1:40mg,bid,d1-14,po,in a 21 day cycle.
Apatinib :A starting dose of apatinib was administered 500 mg daily
Andre navne:
  • Apatinib mesylat tabletter
Oxaliplatin:130 mg/m2,d1,ivgtt,in a 21 day cycle
S-1:40mg,bid,d1-14,po,in a 21 day cycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
reaction rate
Tidsramme: 4 months
4 months

Sekundære resultatmål

Resultatmål
Tidsramme
uønskede hændelser
Tidsramme: 6 måneder
6 måneder
Samlet overlevelse
Tidsramme: 3 år
3 år
Objective Response Rate
Tidsramme: an expected average of 6 weeks
an expected average of 6 weeks
Disease-free survival
Tidsramme: an expected average of 6 weeks
an expected average of 6 weeks
Progression-Free Survival
Tidsramme: an expected average of 6 weeks
an expected average of 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Lin Chen, The Chinese PLA General 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

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. november 2016

Primær færdiggørelse (Forventet)

1. november 2018

Studieafslutning (Forventet)

1. november 2018

Datoer for studieregistrering

Først indsendt

28. december 2016

Først indsendt, der opfyldte QC-kriterier

29. december 2016

Først opslået (Skøn)

2. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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 .

Kliniske forsøg med Mavekræft

Kliniske forsøg med Apatinib

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