To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence)
8mg orally once a day for 1 year
One cycle of TACE postoperatively
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Recurrence-Free Survival (RFS)
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 36 months
RFS Rate at 12 and 24 Months
Time frame: up to 24 months
Overall Survival (OS)
Time frame: Randomization up to approximately 36 months
Adverse events (AEs)
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Randomization up to approximately 36 months
Quality of Life (QoL) Scale Score
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
Time frame: Baseline up to 36 months
Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported
Time frame: Baseline up to 36 months
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