A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezo… (NCT06618664) | Clinical Trial Compass
RecruitingPhase 3
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
China590 participantsStarted 2024-10-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
✕. 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.
✕
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: 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)
2
Overall survival (OS)
Timeframe: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)