A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: SHR-8068+ Adebrelimab+ Bevacizumab, SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo, SHR-8068 Placebo +Adebrelimab+ Bevacizumab.
- Кому может быть актуально
- Состояния в реестре: Hepatocellular Carcinoma. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma
Обзор
This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma. Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
Вмешательства
- Препарат SHR-8068+ Adebrelimab+ Bevacizumab
SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE) - Препарат SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion，Transarterial Chemoembolization(TACE) - Препарат SHR-8068 Placebo +Adebrelimab+ Bevacizumab
SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)
Первичные конечные точки
- Progression-free survival (PFS) assessed by investigator [Срок оценки: Until progression, assessed up to approximately 2 years]
Вторичные конечные точки (9)
- Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC) [Срок оценки: Until progression, assessed up to approximately 2 years]
- Overall survival (OS) [Срок оценки: Until study completion, assessed up to approximately 2 years]
- Objective response rate (ORR) [Срок оценки: Until study completion,assessed up to approximately 2 years]
- Disease control rate (DCR) [Срок оценки: Until study completion,assessed up to approximately 2 years]
- Duration of objective tumor response (DoR) [Срок оценки: Until study completion,assessed up to approximately 2 years]
- Adverse events (AEs) [Срок оценки: Until study completion,assessed up to approximately 2years]
- Serious adverse events (SAEs) [Срок оценки: Until study completion,assessed up to approximately 3 years]
- Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration [Срок оценки: Approximately 90 days post-last dose]
- Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb) [Срок оценки: Approximately 90 days post-last dose]
Критерии участия
Критерии включения
- Age 18-75 years old, male or female;
- Diagnosis confirmed HCC by pathologically or clinically;
- At least one measurable lesion;
- Child-Pugh liver function grade A;
- ECOG-PS score: 0 or 1;
- Eligible for TACE treatment as assessed by the investigator;
- Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period;
- Consent to contraception
Критерии исключения
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
- Participants with any active, known or suspected autoimmune disorder;
- Participants with hypertension which cannot be well controlled by antihypertensives;
- Uncontrolled cardiac diseases or symptoms;
- Participants with hepatic encephalopathy;
- Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
- History of gastrointestinal perforation and/or fistula,
- Participants with other potential factors that may affect the study results.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Zhongshan Hospital，Fudan University — Шанхай
Идентификаторы
NCT: NCT07691762 · SHR-8068-305