- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04080154
Study of Anlotinib After Lenvatinib in Patients With Hepatocellular Carcinoma (ALTER-H-002)
1 de abril de 2020 actualizado por: Shanghai Zhongshan Hospital
A Single Arm, Open-label Study of Anlotinib in Patients With Hepatocellular Carcinoma (HCC) After Lenvatinib
This clinical study evaluates the efficacy and safety of anlotinib in patients with hepatocellular carcinoma who have progressed on lenvatinib treatment.
It is a single arm, open-label clinical trial conducted in China, and plan to recruit 28 patients.
Primary endpoint of the study is Progress Free Survival.
Descripción general del estudio
Descripción detallada
Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling.
The prime targets of anlotinib include receptor tyrosine kinases vascular endothelial growth factor receptor1 to 3 (VEGFR1-3), fibroblast growth factor receptor 1 to 4 (FGFR1-4), platelet-derived growth factor receptor α and β (PDGFR α, β), and stem cell factor receptor.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
28
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xiaowu Huang, doctor
- Número de teléfono: 86-21-60268618
- Correo electrónico: huang.xiaowu@zs-hospital.sh.cn
Copia de seguridad de contactos de estudio
- Nombre: Qiman Sun
- Correo electrónico: sun.qiman@zs-hospital.sh.cn
Ubicaciones de estudio
-
-
-
Shanghai, Porcelana, 200032
- Reclutamiento
- 180 Fenglin Road
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients participate in the study voluntarily and sign informed consent.
- Histological or cytological confirmation of hepatocellular carcinoma (HCC) or non-invasive diagnosis of HCC as per Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition).
- Barcelona Clinic Liver Cancer stage Category C or B that cannot benefit from local treatment.
- Liver function status Child-Pugh Class A or Class B (≤7 points).
- Failure to prior treatment with lenvatinib according to the RECIST1.1. The last dose of lenvatinib should be over 2 weeks and within 10 weeks before the first dose of anlotinib.
- At least one measurable lesion according to the RECIST1.1.
- Eastern Cooperative Oncology Group Performance Status 0 or 1. Life expectancy of at least 3 months.
- Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, Platelet count (PLT) ≥ 60×109/L, Albumin≥ 28g/L, Total bilirubin (TBIL) ≤ 2.0 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 ×ULN, Serum creatinine (Cr) ≤ 1.5× ULN, Hepatitis B virus DNA (HBV-DNA)<1000copy/ml.)
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion Criteria:
- Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms).
- Liver function status Child-Pugh Class C, with malignant ascites.
- Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than Common Terminology Criteria for Adverse Events (CTCAE) 3 grade within 4 weeks prior to enrollment.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Prior systemic treatment for HCC, except lenvatinib. Intolerance of lenvatinib (defined as not less than 20 days at a minimum daily dose of 400 mg within the last 28 days).
- Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- Known history or symptomatic metastatic brain or meningeal tumors.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
- History of gastrointestinal bleeding due to severe gastroesophageal varices or definite tendency of gastrointestinal bleeding, or definite gastrointestinal bleeding tendency due to other causes, such as active ulcer, ulcerative colitis, etc. Fecal occult blood ≥ ++.
- Any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>16 s, Activated partial thromboplastin time (APTT) >48 s, Thrombin time (TT)>21 s, International normalized ratio (INR)>2, fibrinogen (FIB)<2 g/L.
- Patients who underwent major surgery within 4 weeks.
- Patients who have got non remissive toxic reactions derived from lenvatinib treatment, which is over level 2 in CTC AE (4.0).
- Patients with any severe and/or unable to control diseases,including: Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥480ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g.
- Patients whose tumors had invaded important blood vessels by imaging or who, as determined by the researchers, were likely to invade important blood vessels during follow-up trial, resulting in fatal bleeding.
- Female patients who are pregnant or breastfeeding.
- Patients with drug abuse history and unable to get rid of or patients with mental disorders.
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Anlotinib
Anlotinib p.o., qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent.
|
12mg orally (p.o.) every day (qd) for 2 weeks of every 3 week cycle (i.e. 2 weeks on, 1 week off)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progress free survival (PFS)
Periodo de tiempo: each 42 days up to progressive disease (PD) or death (up to 24 months)
|
Progress free survival is defined as the time from first day of anlotinib treatment until the first date of either objective disease progression or death due to any cause, whichever occurs first.
|
each 42 days up to progressive disease (PD) or death (up to 24 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Survival (OS)
Periodo de tiempo: From first day of anlotinib treatment until death (up to 24 months)
|
Overall survival is defined as the time from first day of anlotinib treatment until the date of death due to any cause or the date of the last contact, at which the patients will be censored.
|
From first day of anlotinib treatment until death (up to 24 months)
|
Objective Response Rate (ORR)
Periodo de tiempo: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST1.1).
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Disease Control Rate (DCR)
Periodo de tiempo: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST1.1.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Periodo de tiempo: Until 30 day safety follow-up visit
|
Until 30 day safety follow-up visit
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Xiaowu Huang, doctor, Shanghai Zhongshan Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de septiembre de 2019
Finalización primaria (Anticipado)
1 de febrero de 2021
Finalización del estudio (Anticipado)
1 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
3 de septiembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2019
Publicado por primera vez (Actual)
6 de septiembre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
1 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2019-173R
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Anlotinib
-
First People's Hospital of HangzhouChia Tai Tianqing Pharmaceutical Group Co., Ltd.ReclutamientoGlioma de alto grado recurrentePorcelana
-
Peking Union Medical College HospitalReclutamientoFeocromocitoma | ParagangliomaPorcelana
-
Peking Union Medical College HospitalReclutamientoParaganglioma Extra-Adrenal | Feocromocitoma maligno de la glándula suprarrenal | Paraganglioma Maligno | Feocromocitoma Metastásico | Paraganglioma MalignoPorcelana
-
First Hospital of Shijiazhuang CityDesconocidoCarcinoma | Cáncer de pulmón de células no pequeñas | Neoplasia pulmonarPorcelana
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.TerminadoCarcinoma medular de tiroidesPorcelana
-
Sun Yat-sen UniversityChia Tai Tianqing Pharmaceutical Group Co., Ltd.ReclutamientoSarcoma de tejido blandoPorcelana
-
First Hospital of Shijiazhuang CityDesconocidoCarcinoma | Cáncer de pulmón de células pequeñas | Neoplasia pulmonarPorcelana
-
The First Affiliated Hospital of Zhengzhou UniversityAún no reclutandoCáncer de cuello uterino
-
Hunan Cancer HospitalFuzhou Pulmonary Hospital of Fujian; Chia Tai Tianqing Pharmaceutical Group Co...ReclutamientoCáncer de pulmón de células pequeñasPorcelana
-
Peking Union Medical College HospitalReclutamientoCáncer colonrectalPorcelana