This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab 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. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab 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
50
Tislelizumab 200mg IV Q3W
TACE will be performed after curative resection (4±1w)
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITING2-year Recurrence Free Survival Rate (2-year RFS rate)
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
Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first.
Time frame: 24 months
Time to recurrence (TTR)
TTR is defined as the time from the date of curative resection to the first documented recurrence.
Time frame: 24 months
Overall Survival (OS)
OS is defined as the time from the date of curative resection until death due to any cause.
Time frame: 24 months
1-year RFS rate
1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 years after curative resection.
Time frame: 12 months
1-year OS rate/2-year OS rate
OS rate is defined as the proportion of patients who have not experienced death from any cause at 12 and 24 months after curative resection.
Time frame: 12 months/24 months
Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.