- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03788174
Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma
8. maj 2019 opdateret af: Fujian Cancer Hospital
Phase II Study on the Second-line Treatment of Gastric Adenocarcinoma With Apatinib Combined With POF(Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)
In previous studies,the investigators found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer.
Apatinib is an orally antiangiogenic agent.
It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer.
Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer.
Now the investigators are going to start a phase 2 trial with apatinib 500mg + POF as second-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
26
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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-
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Fuzhou, Kina, 350014
- Rekruttering
- Rongbo Lin
-
Kontakt:
- Rongbo Lin
- Telefonnummer: 13705919382 13705919382
- E-mail: rongbo_lin@163.com
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Rekruttering
- Rongbo Lin
-
-
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:
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
- Previous first-treatment with chemotherapy or radiation therapy failed. Ability to take medications orally. With measurable lesions. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
- Life expectancy ≥3 months. With normal electrocardiogram results and no history of congestive heart failure.
- Without bleeding and thrombosis disease. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
- With good compliance and agree to accept follow-up of disease progression and adverse events.
Exclusion Criteria:
- Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
- Patients with brain or central nervous system metastases, including leptomeningeal disease.
- Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound, ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
- History of a stroke or CVA within 6 months. Clinically significant peripheral vascular disease. Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
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 |
|---|---|
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Eksperimentel: Apatinib plus POF
Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
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Apatinib (500 mg qd p.o.) indtil sygdomsprogression eller utålelig toksicitet eller afvist af patienterne.
POF-kuren bestod af en 3-timers infusion af paclitaxel (135 mg/m2) efterfulgt af oxaliplatin (85 mg/m2) og Calcium Levofolinat (200 mg/m2). Efterfølgende en 46-timers infusion af fluorouracil (2400 mg/m2). m2) blev administreret ved hjælp af en ambulatorisk pumpe, gentaget cyklus hver 14. dag.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective response rate
Tidsramme: From enrollment to 3 months after treatment
|
According to RECIST 1.1
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From enrollment to 3 months after treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progression-free survival
Tidsramme: From enrollment to progression of disease. Estimated about 12 months.
|
The length of time from enrollment until the time of progression of disease
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From enrollment to progression of disease. Estimated about 12 months.
|
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Overall survival
Tidsramme: From enrollment to death of patients. Estimated about 18 months
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The length of time from enrollment until the time of death
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From enrollment to death of patients. Estimated about 18 months
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Toxicity According to NCI CTCAE 4.03 criteria
Tidsramme: From enrollment to 3 months after treatment
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According to NCI CTCAE 4.03 criteria
|
From enrollment to 3 months after treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2019
Primær færdiggørelse (Forventet)
1. december 2019
Studieafslutning (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
23. december 2018
Først indsendt, der opfyldte QC-kriterier
25. december 2018
Først opslået (Faktiske)
27. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. maj 2019
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FNF013
Plan for individuelle deltagerdata (IPD)
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