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Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC

2 de marzo de 2021 actualizado por: Ping Liang, Chinese PLA General Hospital

Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma

In this study, investigators aimed to evaluated the efficacy and safety of microwave ablation combined with anlotinib and TQB2450 Solution in patients with advanced hepatocellular carcinoma. Patients were randomly assigned at a one-to-one ratio to receive microwave ablation plus anlotinib and TQB2450 Solution or microwave ablation plus TQB2450 Solution. Primary end points were objective response rate(ORR). Second end points include overall survival, progression-free survival and disease control rate. Safety was assessed in all patients.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

80

Fase

  • Fase 3

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: Ping Liang
  • Número de teléfono: +8601066939530 +8601066939530
  • Correo electrónico: liangping301@126.com

Ubicaciones de estudio

    • Beijing
      • Beijing, Beijing, Porcelana, 100853
        • Chinese PLA General Hospital

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 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. ECOG PS score: 0-1, Life expectancy of 3 months or more
  2. Subjects must have confirmed diagnosis of HCC
  3. BCLC B and C grade
  4. At least 1 measurable target lesion according to mRECIST
  5. Child-Pugh score A to B
  6. No locoregional therapy within 4 weeks before enrollment for patients with unresectable HCC or tumor progression after locoregional therapy; All toxicities related to prior treatments must be resolved to Grade ≤1
  7. No prior treatment with anti-angiogenic drugs or any anti-PD-1 agent within 4 weeks before enrollment
  8. HBV DNA<500IU/mL
  9. Adequate organ function within 14 days before enrollment
  10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of study drug. Women must not be breastfeeding. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment
  11. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

  1. Prior liver transplant
  2. Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control
  3. Prior treatment with an anti-PD-L1
  4. Active autoimmune disease that has required systemic treatment in past 2 years
  5. Known or suspected allergy to Anlotinib and TQB2450 Solution or study drug components;History of severe hypersensitivity reaction to any monoclonal antibody
  6. Has received a live-virus vaccination within 30 days of planned treatment start.
  7. Subjects with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
  8. Subjects with any active, known, or suspected autoimmune disease; Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  9. HBV DNA ≥ 1000 IU/ml,HCV RNA
  10. New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months, Prolongation of QTc (Fridericia formula) interval to >480 ms
  11. Dysfunction of blood coagulation (INR>1.5 or APTT>1.5×ULN), Bleeding or thrombotic disorders
  12. Anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Antiplatelet agents and low molecular weight heparin are prohibited throughout the study
  13. Active infection (any infection requiring systemic treatment)
  14. History of solid organ or hematologic transplant
  15. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Anlotinib and TQB2450 solution
Microwave ablation will be performed according to patients' tumor number, size and liver function. Oral anlotinib (12 mg/d) will be administered and its cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks. The treatment continues until disease progression or treatment intolerance. Anlotinib and TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
Anlotinib is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
Comparador activo: TQB2450 Solution
Microwave ablation will be performed according to patients' tumor number, size and liver function. Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks.TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ORR
Periodo de tiempo: 2-year
Objective Response Rate
2-year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
OS
Periodo de tiempo: 2-year
Overall Survival
2-year
PFS
Periodo de tiempo: 2-year
Progression-free Survival
2-year
DCR
Periodo de tiempo: 2-year
Disease Control Rate
2-year
EORTC QLQ C30
Periodo de tiempo: Change from baseline health related quality of life at 2 years
Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. EORTC QLQ C30 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.
Change from baseline health related quality of life at 2 years
EORTC QLQ-HCC18
Periodo de tiempo: Change from baseline health related quality of life at 2 years
Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using HCC-specific EORTC QLQ-HCC18 questionnaire. EORTC QLQ-HCC18 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.
Change from baseline health related quality of life at 2 years
AE
Periodo de tiempo: 2-year
Incidence of Adverse Events
2-year
SAEs
Periodo de tiempo: 2-year
Incidence of Severe Adverse Events
2-year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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 (Anticipado)

5 de marzo de 2021

Finalización primaria (Anticipado)

31 de diciembre de 2022

Finalización del estudio (Anticipado)

31 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

30 de noviembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

7 de diciembre de 2020

Publicado por primera vez (Actual)

11 de diciembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 301jrcsk-lp-yj

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 and TQB2450 solution

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