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- Essai clinique NCT02943252
The Clinical Study of Apatinib Plus S1 for Patients With Advanced Non-squamous Head and Neck Cancer
21 octobre 2016 mis à jour par: Xiaohui He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PhaseⅡSingle-center, Open-label, Exploratory Clinical Study of Apatinib in Combination With S1 for the Patients With Advanced Non-squamous Head and Neck Cancer
This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.
Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy.
Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis.
S1 is a new kind of oral fluorouracil antineoplastic chemotherapy drugs.
In vitro, apatinib has synergy effect with fluorouracil.
In this study, the investigators try to evaluate the efficacy and safety of apatinib and S1 in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.
Type d'étude
Interventionnel
Inscription (Anticipé)
30
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100021
- Recrutement
- Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
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Contact:
- Xiaohui He, B.D.
- Numéro de téléphone: +86-13810670129
- E-mail: xiaohuih2008@163.com
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Contact:
- Lin Gui, M.D.
- Numéro de téléphone: +86-13520372817
- E-mail: guilindoctor@126.com
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Chercheur principal:
- Xiaohui He, B.D.
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Sous-enquêteur:
- Lin Gui, M.D.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 18 years to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
- Life expectancy of more than 12 weeks;
- At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months;
- Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma;
- Recurrent and or metastatic lesions which are not suitable for local treatment;
- For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months;
- For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases;
- Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) < 1.5 or PT < ULN+4s or activated partial thromboplastin time (APTT) < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs;
- For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
- Signed informed consent.
Exclusion Criteria:
- Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
- Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
- Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
- Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration;
- Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
- Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
- History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization;
- Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan;
- Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI);
- Treatment with other investigational drugs or other anti-cancer therapy;
- Previous therapy with other VEGFR inhibitors (other than bevacizumab);
- Treatment in another investigational trial =< 4 weeks prior to registration;
- History of hypersensitivity to apatinib and/or the excipients of the trial drugs;
- Active or chronic hepatitis C and/or B infection, or other active uncontrolled infection;
- History of immunodeficiency disease (including HIV positive), concurrent acquired or congenital immunodeficiency syndrome, or history of organ transplantation;
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration;
- History of arterial or venous thromboembolic events (e.g. cerebrovascular accident, cardiovascular accident, deep venous thrombosis and pulmonary embolism) =< 12 months prior to randomization;
- Administration of strong/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days;
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study;
- History of mental diseases;
- Other conditions regimented at investigators' discretion.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Apatinib plus S1
Patients received oral apatinib 500 mg in tablet once daily.
Patients also received oral S1 in capsule 40-60mg bid, days 1-14.
A treatment cycle was defined as 21 days (3 weeks).
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apatinib 500 mg in tablet once daily
Autres noms:
S-1 40-60mg bid, days 1-14 , every 3 weeks
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Response Rate
Délai: up to 3 years
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up to 3 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Survie sans progression
Délai: jusqu'à 3 ans
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jusqu'à 3 ans
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La survie globale
Délai: jusqu'à 3 ans
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jusqu'à 3 ans
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Nombre de participants présentant des événements indésirables liés au traitement, évalués par CTCAE v4.0
Délai: jusqu'à 3 ans
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jusqu'à 3 ans
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Autres mesures de résultats
Mesure des résultats |
Délai |
---|---|
serum soluble VEGFR2
Délai: baseline
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baseline
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expressions du VEGFR2 phosphorylé tumoral (p-VEGFR2)
Délai: ligne de base
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ligne de base
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Xiaohui He, B.D., Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
- Le Tourneau C, Razak AR, Levy C, Calugaru V, Galatoire O, Dendale R, Desjardins L, Gan HK. Role of chemotherapy and molecularly targeted agents in the treatment of adenoid cystic carcinoma of the lacrimal gland. Br J Ophthalmol. 2011 Nov;95(11):1483-9. doi: 10.1136/bjo.2010.192351. Epub 2010 Dec 22.
- Yamashita T, Shinden S, Watabe T, Shiotani A. Outpatient chemotherapy with S-1 for recurrent head and neck cancer. Anticancer Res. 2009 Feb;29(2):577-81.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2016
Achèvement primaire (Anticipé)
1 octobre 2019
Achèvement de l'étude (Anticipé)
1 octobre 2021
Dates d'inscription aux études
Première soumission
19 octobre 2016
Première soumission répondant aux critères de contrôle qualité
21 octobre 2016
Première publication (Estimation)
24 octobre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
24 octobre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 octobre 2016
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CH-H&N-008
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Tumeurs de la tête et du cou
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Mathematica Policy Research, Inc.Boston Children's Hospital; Department of Health and Human ServicesPas encore de recrutementIntervention précoce, éducation (Head Start et Early Head Start Access and Participation)États-Unis
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Novartis PharmaceuticalsRecrutementAdvanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,MélanomePays-Bas, Corée, République de, Espagne, Taïwan, Japon, Italie, États-Unis, Singapour, Canada
Essais cliniques sur Apatinib
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Peking University Cancer Hospital & InstituteRecrutement
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Lei LiComplétéChimiothérapie | Carcinome cervical récurrent | Apatinib | Thérapie ciblée | Carcinome cervical avancé persistant | Inhibiteur du facteur de croissance endothélial vasculaire 2Chine
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Huazhong University of Science and TechnologyInconnue
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Ruijin HospitalActif, ne recrute pasAdénocarcinome de la jonction gastrique et gastro-oesophagienne (GEJ)Chine
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The First Affiliated Hospital of Zhengzhou UniversityRecrutementCancer de l'œsophage selon le stade AJCC V8Chine
-
Peking UniversityJiangsu HengRui Medicine Co., Ltd.Recrutement
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The First Affiliated Hospital of Zhengzhou UniversityRecrutement
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Peking Union Medical College HospitalComplétéCancer de la thyroïdeChine
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Beijing HospitalChinese Society of Clinical OncologyRecrutement
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Peking Union Medical College HospitalJiangsu HengRui Medicine Co., Ltd.RecrutementNéoplasie trophoblastique gestationnelleChine