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JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer

11 de setembro de 2026 atualizado por: Shanghai Junshi Bioscience Co., Ltd.

A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of JS207 in Combination With JS007 Versus Toripalimab in Combination With Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma

This is a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC.

All study participants have unresectable locally advanced, recurrent, or metastatic HCC and have not previously received systemic anti-tumor therapy for advanced disease.

Approximately 560 participants are planned to be enrolled in this study. The JS207 + JS007 group (experimental group) and the toripalimab + bevacizumab group (positive control group) are each planned to enroll 280 participants.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a multicenter, randomized, open-label, active-controlled Phase III study in participants with unresectable locally advanced, recurrent, or metastatic hepatocellular carcinoma.Tumor images will be assessed by investigator and blinded independent central review (BICR). Treatment will continue until protocol-defined discontinuation criteria are met, for a maximum of 2 years. Participants will undergo tumor assessments, safety assessments, and survival follow-up.

Anti-tumor activity will be assessed by determining best overall response (BOR), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (BICR-PFS and INV Safety will be assessed through AEs, laboratory variables, physical examination findings, vital signs, 12-lead electrocardiogram, echocardiography, and ECOG performance status. The severity of AEs will be graded per NCI-CTCAE v6.0.

Participants in the JS207 + JS007 group (experimental group) will undergo plasma concentration assessments and immunogenicity assessments for JS207 and JS007.

The EORTC QLQ-C30, EORTC QLQ-HCC18, and EQ-5D-5L questionnaires will be used to assess participants' health-related quality of life (HRQOL).

Tipo de estudo

Intervencional

Inscrição (Estimado)

560

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

Estude backup de contato

Locais de estudo

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
        • Contato:
          • Tongsen Zheng, Ph.D.
          • Número de telefone: +86 15134569619
          • E-mail: ztsgcp@126.com
        • Investigador principal:
          • Tongsen Zheng, Ph.D.
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan hospital, Fudan university
        • Contato:
        • Contato:
        • Investigador principal:
          • Jia Fan, Ph.D.
        • Subinvestigador:
          • Guoming Shi, Ph.D.

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Voluntarily participate and sign a written informed consent form.
  • Aged 18-75 years, regardless of sex.
  • Histologically/cytologically confirmed HCC, or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
  • No prior systemic therapy for HCC.
  • At least one measurable lesion per RECIST v1.1 criteria.
  • Child-Pugh liver function grade A or grade B with a score ≤7, and no history of hepatic encephalopathy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
  • Expected survival ≥ 12 weeks.
  • Adequate hematologic and end-organ function.
  • Female participants of childbearing potential and male participants with female partners of childbearing potential must use a highly effective contraceptive method during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood HCG test within 7 days prior to study enrollment and must not be breastfeeding.

Exclusion Criteria:

  • Concomitant with the following study disease states: Known intrahepatic cholangiocarcinoma (ICC) or mixed-type liver cancer, sarcomatoid hepatocellular carcinoma, and fibrolamellar carcinoma of the liver; Presence of HCC central nervous system metastasis.
  • Prior treatment-related toxicity not recovered to ≤ CTCAE Grade 1.
  • Severe infection at screening.

  • Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically apparent moderate or greater ascites at screening.

    -≥ Grade 3 (NCI-CTCAE v6.0) gastrointestinal or non-gastrointestinal fistula at screening.

  • Severe unhealed wounds, active ulcers, or untreated fractures at screening.
  • Severe cardiovascular or cerebrovascular disease:
  • History of gastrointestinal bleeding within 6 months prior to the first dose, or definite tendency for gastrointestinal bleeding.
  • Other obvious bleeding tendency or evidence of major coagulation disorders:
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
  • Malignancy other than HCC within 5 years prior to the first dose.
  • Confirmed or suspected moderate-to-severe pulmonary disease severely affecting pulmonary function.
  • Active tuberculosis.
  • Co-infection with hepatitis B and hepatitis C.
  • Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or solid organ transplantation, or other immunodeficiency.
  • Known history of severe allergy to any monoclonal antibody.
  • Other factors that, in the investigator's judgment, may affect study results or lead to forced premature termination of the study.

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: JS207 plus JS007
Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion
Medicamento: JS207
PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
Medicamento: JS007
CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Comparador Ativo: Toripalimab plus bevacizumab
Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion
Medicamento: Toripalimab
PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Medicamento: Bevacizumab
VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Prazo: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Time from randomization to the first documented disease progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Overall Survival (OS)
Prazo: From randomization to death from any cause; assessed up to 66 months.
Time from randomization to death from any cause. After safety follow-up, survival status is assessed every 2 months until death, loss to follow-up, withdrawal of consent, or study termination.
From randomization to death from any cause; assessed up to 66 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Prazo: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Time from randomization to first documented disease progression assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Objective Response Rate Assessed by BICR (ORR)
Prazo: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR). Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Objective Response Rate Assessed by the Investigator (ORR)
Prazo: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR). Responses and progression are assessed by the investigator per RECIST v1.1.
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Disease Control Rate Assessed by BICR (DCR)
Prazo: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD). Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Disease Control Rate Assessed by the Investigator (DCR)
Prazo: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD). Responses and progression are assessed by the investigator per RECIST v1.1.
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Duration of Response Assessed by BICR (DoR)
Prazo: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders. Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Duration of Response Assessed by the Investigator (DoR)
Prazo: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders. Responses and progression are assessed by the investigator per RECIST v1.1.
From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Number of Participants With Adverse Events
Prazo: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Adverse events (AEs) are summarized by incidence, severity, and outcome. Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Number of Participants With Serious adverse events (SAEs)
Prazo: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Serious adverse events (SAEs) are summarized by incidence, severity, and outcome. Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Number of Participants With Immune-related AEs
Prazo: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Immune-related AEs are summarized by incidence, severity, and outcome. Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Blood Concentrations of JS207
Prazo: Up to 27 months
Concentrations of JS207 in serum, measured using the validated bioanalytical assay.
Up to 27 months
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (ADAs) for JS207
Prazo: Up to 27 months
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Up to 27 months
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (NAb) for JS207
Prazo: Up to 27 months
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Up to 27 months
Blood Concentrations of JS007
Prazo: Up to 27 months.
Concentrations of JS007 in serum, measured using the validated bioanalytical assay.
Up to 27 months.
Immunogenicity of JS007 assessed by the presence of antidrug antibodies (ADAs) for JS007
Prazo: Up to 27 months.
Presence of antidrug antibodies (ADAs) for JS007 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Up to 27 months.
Immunogenicity of JS007 assessed by the presence of antidrug antibodies (NAb) for JS007
Prazo: Up to 27 months
Presence of antidrug antibodies (ADAs) for JS007 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Up to 27 months
EORTC QLQ-C30 Scores
Prazo: Up to 25 months
Patient-reported scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scale and item scores range from 0 to 100.
Up to 25 months
EORTC QLQ-HCC18 Scores
Prazo: Up to 25 months.
Patient-reported scores on the EORTC hepatocellular carcinoma-specific quality-of-life questionnaire (QLQ-HCC18). Symptom and problem scores range from 0 to 100.
Up to 25 months.
EQ-5D-5L
Prazo: Up to 25 months
There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measures health state.
Up to 25 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Junshi Bioscience Co., Ltd.

Investigadores

  • Investigador principal: Jia Fan, Ph.D., Fudan University

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 (Estimado)

8 de outubro de 2026

Conclusão Primária (Estimado)

30 de outubro de 2029

Conclusão do estudo (Estimado)

30 de outubro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

11 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2026

Primeira postagem (Real)

16 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 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

  • JS207-017-III-HCC

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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 .

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