A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
22 de septiembre de 2026 actualizado por: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
This study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
590
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: Xin Shi
- Número de teléfono: +86-0518-82342973
- Correo electrónico: xin.shi.xs3@hengrui.com
Copia de seguridad de contactos de estudio
- Nombre: Ying Sun
- Número de teléfono: +86-0518-82342973
- Correo electrónico: ying.sun.ys1@hengrui.com
Ubicaciones de estudio
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Anhui
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Hefei, Anhui, Porcelana, 230000
- Reclutamiento
- Anhui Provincial Hospital
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Investigador principal:
- Shukui Qin
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Investigador principal:
- Lianxin Liu
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Contacto:
- Lianxin Liu
- Número de teléfono: +86-13845159888
- Correo electrónico: liulx@ustc.edu.cn
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Contacto:
- Shukui Qin
- Número de teléfono: +86-13905158713
- Correo electrónico: qinsk@csco.org.cn
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Able and willing to provide a written informed consent.
- ≥ 18 years old, both male and female.
- Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
- At least one measurable lesion based on RECIST v1.1 criteria.
- Barcelona clinic liver cancer: Stage B or C.
- No previous systemic antitumor therapy for HCC.
- ECOG PS of 0-1.
- Child-Pugh score of A or B7.
- Expected survival period ≥ 12 weeks.
- Adequate organ function.
- Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.
Exclusion Criteria:
- Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
- Patients with other malignancies currently or within the past 5 years.
- With known severe allergic reactions to any other monoclonal antibodies.
- Patients with known CNS metastasis or hepatic encephalopathy.
- Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
- Patients with symptomatic ascites or pleural effusion.
- Patients with hypertension which cannot be well controlled by antihypertensives.
- Uncontrolled cardiac diseases or symptoms.
- Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
- Major vascular disease occurred in the 6 months before randomization.
- Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
- Major surgery within 28 days before randomization or expected to require major surgery during the study period.
- Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
- Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
- Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
- Patients with other potential factors that may affect the study results.
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: SHR-8068 combinado con Adebrelimab y Bevacizumab
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SHR-8068: injection, 50 mg/10 mL, intravenous infusion Adebrelimab: injection, 600 mg/12 mL, intravenous infusion Bevacizumab: injection, 100 mg/4 mL, intravenous infusion |
|
Comparador activo: Sintilimab combinado con bevacizumab
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Bevacizumab: injection, 100 mg/4 mL, intravenous infusion Sintilimab: injection, 100 mg/10 mL, intravenous infusion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression Free Survival (PFS)
Periodo de tiempo: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
|
From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
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|
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Overall survival (OS)
Periodo de tiempo: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
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OS is defined as the time from randomization to death from any cause. |
From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
La incidencia, gravedad y relevancia para los fármacos en investigación de eventos adversos (EA) y eventos adversos graves (AAG) según NCI-CTCAE v5.0
Periodo de tiempo: Desde la fecha del ICF hasta el final del seguimiento de seguridad o inicio de nueva terapia antitumoral (hasta aproximadamente 36 meses)
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Desde la fecha del ICF hasta el final del seguimiento de seguridad o inicio de nueva terapia antitumoral (hasta aproximadamente 36 meses)
|
|
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Time to Progression (TTP)
Periodo de tiempo: From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
|
TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
|
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Disease Control Rate (DCR)
Periodo de tiempo: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
|
DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
|
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Objective Response Rate (ORR)
Periodo de tiempo: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
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ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
|
|
Duration of Response (DoR)
Periodo de tiempo: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
|
DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first). |
From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
|
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Time to Response (TTR)
Periodo de tiempo: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
|
TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
28 de octubre de 2024
Finalización primaria (Estimado)
1 de octubre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
26 de septiembre de 2024
Primero enviado que cumplió con los criterios de control de calidad
26 de septiembre de 2024
Publicado por primera vez (Actual)
1 de octubre de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SHR-8068-301
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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
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