- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03707639
Study of the Combination of Apatinib and POF
Phase II Study of the Combination of Apatinib and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Rongbo Lin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
No previous treatment with chemotherapy or radiation therapy. 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
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: Experimental: Apatinib plus POF
Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
|
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
|
From enrollment to 3 months after treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
From enrollment to progression of disease. Estimated about 12 months.
|
|
Overall survival
Tidsramme: From enrollment to death of patients. Estimated about 18 months
|
The length of time from enrollment until the time of death
|
From enrollment to death of patients. Estimated about 18 months
|
|
Toxicity According to NCI CTCAE 4.03 criteria
Tidsramme: From enrollment to 3 months after treatment
|
According to NCI CTCAE 4.03 criteria
|
From enrollment to 3 months after treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Rongbo Lin, Fujian Cancer Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
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
Andre undersøgelses-id-numre
- FNF011
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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-
Jiangsu Cancer Institute & HospitalIkke rekrutterer endnuEsophagogastric Junction/Gastric Adenocarcinoma
-
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-
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-
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-
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-
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-
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-
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-
Guangzhou Virotech Pharmaceutical Co., Ltd.Rekruttering
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