A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma

Официальное название

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma

Обзор

THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.

Вмешательства

• Препарат SHR-8068
  SHR-8068: injection, 50 mg/10 mL, intravenous infusion
• Препарат Adebrelimab
  Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
• Препарат Bevacizumab
  Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
• Препарат Sintilimab
  Sintilimab: injection, 100 mg/10 mL, intravenous infusion
• Препарат Atezolizumab injection
  Atezolizumab injection.

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: 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) [Срок оценки: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)]

Вторичные конечные точки (6)

• Time to Progression (TTP) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]
• The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0 [Срок оценки: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Provincial Hospital — Хэфэй

Идентификаторы

NCT: NCT06618664 · SHR-8068-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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