- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02489409
Recombinant Human Endostatin (EndostarTM) Injection in Treatment of Recurrent Metastatic Breast Cancer
12. juli 2017 opdateret af: Shun-E Yang, Xinjiang Medical University
EndostarTM Injection Combined With Gemcitabine+Platinum (GP)/Navelbine+Platinum (NP)/Gemcitabine+Xeloda (GX)/Navelbine+Xeloda (NX) in Treatment of Recurrent Metastatic Breast Cancer: A Randomized, Opened and Controlled Clinical Study
Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors.
Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC).
However, the research about the efficacy of Endostatin on breast cancer has just started.
Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy.
Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations.
So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad.
To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Large amounts of studies have proved that the development of tumor vessels mainly depend on the activation, proliferation, adhesion and maturity of vascular endothelial cells, which may also become the targets of vascular inhibitors.
At present, Avastin, an anti-angiogenesis drug, has been marketed in Euopean and American countries, and another 30 kinds of vascular inhibitors are still in trails.
Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors.
Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC).
However, the research about the efficacy of Endostatin on breast cancer has just started.
Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy.
Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations.
So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad.
To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
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
-
-
Xinjiang
-
Urumchi, Xinjiang, Kina, 830000
- Rekruttering
- Third Affiliated Hospital of Xinjiang Medical University
-
Kontakt:
- Shun-E Yang, Professor
- Telefonnummer: 15805197983
- E-mail: 319889719@qq.com
-
Kontakt:
- Xun Li, Assistant
- Telefonnummer: 7819371 0991-7819372
- E-mail: yangshune@medmail.com.cn
-
-
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
Kvinde
Beskrivelse
Inclusion Criteria:
- Age: 18~70 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1 score;
- All patients were diagnosed as recurrent metastatic breast cancer retreatment by histopathology and computed tomography (CT) examination;
- The measurable nidus≥1: Patients whose nidus diameter ≥ 20 mm by normal CT or magnetic resonance image (MRI) scanning, and ≥ 10 mm by spiral CT scanning;
- Patients whose blood routine, hepatorenal function, electrolyte and cardiac function were basically normal without dysfunction of primary organs. White blood cell count (WBC) ≥4.0×109/L, neutrophile granulocyte count ≥1.5×109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥95 g/L, serum bilirubin (BIL) ≤1.5-fold upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2-fold upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
- The expected survival time >3 months;
- Patients who could understand this study status and had signed the informed consent forms.
Exclusion Criteria:
- Patients who had history of allergic responses to biological agents;
- Patients who were receiving other anti-tumor therapies;
- Patients without measureable nidus;
- Others, including one of the following conditions: patients with uncontrolled central nervous system (CNS) metastatic nidi, with dysfunction of important organs and severe cardiac diseases (congestive heart failure, uncontrollable arrhythmia, and angina pectoris, valvular heart disease, myocardial infarction and refractory hypertension that required long-term drug administration), with chronic infectious wound and with history of uncontrollable psychosis, and women in pregnant or lactation period.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Experimental group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14; EndostarTM Injection: 210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h).
|
210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
Andre navne:
1.0 m/m2, iv 0.5h, d1, 8
Andre navne:
40 mg/d, iv, d1, 8
Andre navne:
30 mg/m2, iv 3h, d1-3
Andre navne:
2 000 mg/m2, po, d1-14
Andre navne:
|
Aktiv komparator: Control group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14.
|
1.0 m/m2, iv 0.5h, d1, 8
Andre navne:
40 mg/d, iv, d1, 8
Andre navne:
30 mg/m2, iv 3h, d1-3
Andre navne:
2 000 mg/m2, po, d1-14
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
response rate
Tidsramme: 2 years
|
response rate that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment.
ORR=(CR+ CRu+ PR)cases/total cases×100%.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
clinical benefit rate
Tidsramme: 2 years
|
clinical benefit rate that defined as the total ratio of study subjects with complete response,partial response and stable disease more than 24 months after treatment.
|
2 years
|
progression-free survival
Tidsramme: 2 years
|
Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died from the start of randomization.
|
2 years
|
median survival time
Tidsramme: 2 years
|
median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.
|
2 years
|
overall survival
Tidsramme: 2 years
|
overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization
|
2 years
|
adverse responses
Tidsramme: 2 years
|
adverse responses that defined as the evaluated by rates of all adverse reactions caused by Recombinant Human Endostatin and the changes of all indexes before and after treatment
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shun-E Yang, Professor, Third Affiliated Hospital of Xinjiang Medical University
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. oktober 2015
Primær færdiggørelse (Forventet)
1. maj 2018
Studieafslutning (Forventet)
1. juli 2018
Datoer for studieregistrering
Først indsendt
1. juli 2015
Først indsendt, der opfyldte QC-kriterier
1. juli 2015
Først opslået (Skøn)
3. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Gemcitabin
- Vinorelbin
- Endostatiner
Andre undersøgelses-id-numre
- XinjiangMU001
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 .
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