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

11 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Интервенционный

Регистрация (Оцененный)

560

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Jiazheng Yan, Project Manager
  • Номер телефона: +86 158 2259 6147
  • Электронная почта: jiazheng_yan@junshipharma.com

Учебное резервное копирование контактов

  • Имя: Feng Li
  • Номер телефона: +86 186 2772 1499
  • Электронная почта: feng_li@junshipharma.com

Места учебы

  • Китай
    • Heilongjiang
      • Harbin, Heilongjiang, Китай, 150081
        • Harbin Medical University Cancer Hospital
        • Контакт:
          • Tongsen Zheng, Ph.D.
          • Номер телефона: +86 15134569619
          • Электронная почта: ztsgcp@126.com
        • Главный следователь:
          • Tongsen Zheng, Ph.D.
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 200032
        • Zhongshan hospital, Fudan university
        • Контакт:
        • Контакт:
        • Главный следователь:
          • Jia Fan, Ph.D.
        • Младший исследователь:
          • Guoming Shi, Ph.D.

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: JS207 plus JS007
Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion
Лекарство: JS207
PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
Лекарство: JS007
CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Активный компаратор: Toripalimab plus bevacizumab
Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion
Лекарство: Toripalimab
PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Лекарство: Bevacizumab
VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Временное ограничение: 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)
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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.

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Blood Concentrations of JS207
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Shanghai Junshi Bioscience Co., Ltd.

Следователи

  • Главный следователь: Jia Fan, Ph.D., Fudan University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

8 октября 2026 г.

Первичное завершение (Оцененный)

30 октября 2029 г.

Завершение исследования (Оцененный)

30 октября 2031 г.

Даты регистрации исследования

Первый отправленный

11 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

11 сентября 2026 г.

Первый опубликованный (Действительный)

16 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

11 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • JS207-017-III-HCC

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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