This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring. Until now there is no standard postoperative adjuvant therapy. Various adjuvant treatment methods including immunotherapy, targeted therapy, TACE are being studied. This study is to explore the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Drug: Tislelizumab Tislelizumab 200mg IV q3w Other Names: BGB-A317, Immunotherapy, Anti-PD-1 antibody Drug: Sitravatinib Sitravatinib 100mg PO qd Other Name: tyrosine kinase inhibitor, TKI
Anhui province hospital
Hefei, Anhui, China
RECRUITINGRFS rate
2-year Recurrence Free Survival Rate (2-year RFS rate) \[Time Frame: Observation period 24 months\] 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.
Time frame: Observation period 24 months
TTR
1.Time to recurrence (TTR) \[Time Frame: 24 months\] TTR is defined as the time from the date of curative resection to the first documented recurrence.
Time frame: 24 months
RFS
2.Recurrence-Free Survival (RFS) \[Time Frame: 24 months\] RFS is defined as the time from the date of curative resection to the first documented recurrenceor death due to any cause, whichever occurs first.
Time frame: 24 months
RFS rate
3.1-year RFS rate \[Time Frame: 12 months\] 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 yearsafter curative resection.
Time frame: 12 months
OS
4.Overall Survival (OS)\[Time Frame: 24 months\] OS is defined as the time from the date of curative resection until death due to any cause.
Time frame: 24 months
OS rate
5.1-year OS rate/2-year OS rate \[Time Frame: 12 months/24 months\] OS rate is defined as the proportion of patients who have not experienced death from any causeat 12 and 24 months after curative resection.
Time frame: 12 months/24 months
AEs
6.Adverse Events (AEs) \[ Time Frame: 24 months \] The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
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Time frame: 24 months