- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03199677
A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer
An Exploratory Single-center, Open-label , Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer
Panoramica dello studio
Descrizione dettagliata
This is a single-center, open-label, single arm,exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.
The primary endpoint is objective response rate(ORR),the secondary endpoints include progression-free-survival(PFS);disease control rate(DCR);serum Tg、TgAb、calcitonin;safety.
If any case happens as following,including withdrawing informed consent form(ICF)、unbearable toxicity or adverse reactions、other conditions which investigators think the patients are unsuitable to go on trail,the patient will not go on trial any longer,or every subject will obtain study treatment until tumor progress with CT/MRI proof.The indicators of efficacy and safety will be always observed during the trail process.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Beijing
-
Beijing, Beijing, Cina, 100021
- Reclutamento
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contatto:
- Dawei Wu, professor
- Numero di telefono: 13521689314
- Email: cancergcp@163.com
-
Investigatore principale:
- Shengyu Zhou, professor
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- ≥18 years old,gender limitation.
- The pathologic subtype of thyroid carcinoma, which was confirmed by histopathological histology, included iodine refractory thyroid papillary carcinoma and follicular carcinoma, medullary thyroid carcinoma and undifferentiated carcinoma.
- Patients with at least one measurable lesion (RECIST1.1), at least one measurable lesion after the treatment (spiral CT scan length to diameter 10 mm or higher, according with the requirement of RESCIST version 1.1 standard).
Radioactive iodine deficiency (according with one of the following conditions):
- The target lesion was completely deprived of iodine in the treatment of radioactive iodine;
- The patients were treated with single dose of iodine (3.7 GBq) and the disease progressed in 12 months;
- The patients were given an iodine treatment interval of less than 12 months, and the dose was greater than that 3.7 GBq [≥100mCi], with at least one iodine treatment over 12 months of disease progression;
- Cumulative doses of radioactive iodine were greater than 22.2 GBq (or more than 600 mCi).
- Patients who underwent at least one failure of standard chemotherapy can be recommended to get into the group.
Organs function have to be compliant with the following specifications:
ANC≥1.5×109/L; PLT≥100×109/L; Hb≥90g/L; TBIL≤1.5×ULN; ALT &AST ≤2.5×ULN ; ALT &AST ≤5×ULN in patients with hepatic metastasis; BUN & Cr≤1×ULN, CCR≥50mL/min (Cockcroft-Gault formula); Normal coagulation function (INR<1.5 or PT<ULN+4s or APTT<1.5 ULN); Urinary protein<++ or urine protein quantitation in 24 hours ≤1.0 g.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0~2.
- Pre-menopausal women must have a negative pregnancy test within 7 days before study entry and agree to use a medically acceptable method of contraception throughout the treatment periods and for at least six weeks after treatment discontinuation.
- The subjects volunteered to participate in the study, sign informed consent forms, and compliance with follow-up.
Exclusion Criteria:
- The presence of a third interstitial fluid (such as a large amount of pleural effusion and/or peritoneal fluid, pericardial fluid) that cannot be controlled by a drainage or other methods.
- Before or at the same time with other malignant tumors, except cured skin basal cell carcinoma, cervical carcinoma in situ or other effective treatment of tumors and did not see signs of disease for five years.
- The patients who used VEGFR-TKI drugs, such as Vandetanib, Cabozantinib, Lenvatinib,Sunitinib,Sorafenib in one month.
- Inability to swallow, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption.
- major surgical or severe trauma injuries, fractures, or ulcers before 4 weeks of enrolling , 3 weeks of radiation therapy (except for partial palliative radiation), chemotherapy, and molecular target therapy in three weeks, Treatment with nitrocarbamide or mitomycin before six weeks of enrolling.
- uncontrolled hypertension (systolic blood pressure of 140mmHg or diastolic pressure is greater than 90mmHg, despite the best drug treatment).
- Patients used to suffer from severe cardiovascular diseases: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male ≥450ms, female≥470ms); According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or heart color indicate left ventricular ejection fraction (LVEF) < 50%.
- History of significant hemoptysis within 2 months prior to enrollment or daily hemoptysis is up to 2.5ml;with the trend of haemorrhage or prior treatment with an angiogenesis therapy.
- Significant clinical significance of bleeding symptoms or a definite bleeding tendency happened in three months prior to screening, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.
- Active brain metastasis, cancer meningitis, Spinal cord oppressor activity of brain metastases of, cancer, spinal cord compression patients, CT or MRI examination revealed brain or soft meningeal disease (patients who completed treatment and get stable symptoms with brain metastases can be into the group in 21 days prior to screening, without symptoms of cerebral hemorrhage).
- Imaging (CT or MRI) showed that tumor lesions were less than 5mm from the large blood vessels, or the central type of tumor that had penetrated the large blood vessels, or there is a clear pulmonary void or necrotic tumor.
- Patients accept other anti-tumor therapies at the same time.
- Treatment of thyroid cancer radiation was received 28 days prior to screening.
- Participated in other clinical trials within 4 weeks.
- Active or chronic hepatitis c and/or hepatitis b infection and other active infections (determined by the investigators).
- History of immunodeficiency disease, including human immunodeficiency virus infect(HIV), or acquired immunodeficiency disease (AID) and Congenital immunodeficiency disease, or history of organs for transplantation.
- Abdominal fistula, digestive tract perforation or intra-abdominal abscess happened within six months prior to screening.
- Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack (TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Received a powerful CYP3A4 inhibitor treatment in the first 7 days before the group, or received a powerful CYP3A4 inducer in the first 12 days before the study.
- According to the investigator's judgment, there is serious illness to endanger the safety of patients, the completion of the study (e.g: severe diabetes, renal insufficiency).
- A history of specific neurological or psychiatric disorders, including epilepsy or dementia.
- Other cases that the investigator found ineligible.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: apatinib with 500mg qd po
Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.
|
Apatinib is an oral tyrosine kinase inhibitor.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
objective response rate
Lasso di tempo: 1 year
|
ORR is defined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to Response Evaluation Criteria Solid Tumors(RECIST 1.1).
|
1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
progression-free-survival(PFS)
Lasso di tempo: 1 year
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
|
1 year
|
disease control rate(DCR)
Lasso di tempo: 1 year
|
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1).
|
1 year
|
serum Tg、TgAb、calcitonin
Lasso di tempo: 1 year
|
Evaluating the change of serum level of Tg,TgAb or calcitonin,assessed up to 12 months.
|
1 year
|
Adverse Events(AEs)
Lasso di tempo: 1 year
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
|
1 year
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Neoplasie per sede
- Malattie del sistema endocrino
- Neoplasie delle ghiandole endocrine
- Malattie della tiroide
- Neoplasie della testa e del collo
- Neoplasie tiroidee
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Apatinib
Altri numeri di identificazione dello studio
- AHEAD-RTC001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro refrattario
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutanteStadio III Adenocarcinoma della prostata AJCC v7 | Stadio II Adenocarcinoma prostatico AJCC v7 | Fase I Adenocarcinoma della prostata American Joint Committee on Cancer (AJCC) v7Stati Uniti
Prove cliniche su Apatinib
-
Elevar TherapeuticsCompletatoCarcinoma adenoideo cisticoStati Uniti, Corea, Repubblica di
-
Shanghai Jiao Tong University Affiliated Sixth...SconosciutoSarcoma dei tessuti molli
-
Tianjin Medical University Cancer Institute and...SconosciutoCancro polmonare a piccole celluleCina
-
Peking University Cancer Hospital & InstituteReclutamento
-
Wuhan Union Hospital, ChinaRitiratoCancro colorettale | Chemioterapia | Angiogenesi
-
Lei LiCompletatoChemioterapia | Carcinoma cervicale ricorrente | Apatinib | Terapia mirata | Carcinoma cervicale avanzato persistente | Inibitore del fattore di crescita endoteliale vascolare 2Cina
-
The First Affiliated Hospital of Zhengzhou UniversityReclutamentoCancro esofageo secondo lo stadio AJCC V8Cina
-
Peking UniversityJiangsu HengRui Medicine Co., Ltd.Reclutamento
-
The First Affiliated Hospital of Zhengzhou UniversityReclutamento
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.Sconosciuto