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 setembro de 2026 atualizado 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).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
590
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Xin Shi
- Número de telefone: +86-0518-82342973
- E-mail: xin.shi.xs3@hengrui.com
Estude backup de contato
- Nome: Ying Sun
- Número de telefone: +86-0518-82342973
- E-mail: ying.sun.ys1@hengrui.com
Locais de estudo
-
-
Anhui
-
Hefei, Anhui, China, 230000
- Recrutamento
- Anhui Provincial Hospital
-
Investigador principal:
- Shukui Qin
-
Investigador principal:
- Lianxin Liu
-
Contato:
- Lianxin Liu
- Número de telefone: +86-13845159888
- E-mail: liulx@ustc.edu.cn
-
Contato:
- Shukui Qin
- Número de telefone: +86-13905158713
- E-mail: qinsk@csco.org.cn
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: SHR-8068 combinado com Adebrelimabe e Bevacizumabe
|
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 Ativo: Sintilimabe combinado com Bevacizumabe
|
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion Sintilimab: injection, 100 mg/10 mL, intravenous infusion |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression Free Survival (PFS)
Prazo: 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)
|
|
|
Overall survival (OS)
Prazo: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
A incidência, gravidade e relevância para medicamentos em investigação de eventos adversos (EA) e eventos adversos graves (SAE) de acordo com NCI-CTCAE v5.0
Prazo: Desde a data da CIF até o final do acompanhamento de segurança ou início de nova terapia antitumoral (até aproximadamente 36 meses)
|
Desde a data da CIF até o final do acompanhamento de segurança ou início de nova terapia antitumoral (até aproximadamente 36 meses)
|
|
|
Time to Progression (TTP)
Prazo: 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)]
|
|
Disease Control Rate (DCR)
Prazo: 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)
|
|
Objective Response Rate (ORR)
Prazo: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
|
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)
Prazo: 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)
|
|
Time to Response (TTR)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de outubro de 2024
Conclusão Primária (Estimado)
1 de outubro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
26 de setembro de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de setembro de 2024
Primeira postagem (Real)
1 de outubro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SHR-8068-301
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .