A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
687
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangxi Medical University Affiliated Tumor Hospital
Nanjin, Guangzhou, China
Guizhou Cancer Hospital
Guiyang, Guizhou, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Time frame: Randomization up to approximately 43 months
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Time frame: Randomization up to 24 months and up to 36 months
Time to Recurrence (TTR) as determined by the investigator and by BIRC
TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC
Time frame: Randomization up to approximately 43 months
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Time frame: Randomization up to approximately 43 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline up to approximately 43 months
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China