This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.
Ablation is one of the main treatments for early recurrent HCC, and its immune stimulation is expected to improve the efficacy of anti-PD-1 immune checkpoint inhibitor therapy. Tislelizumab is a new immunotherapy agent with independent intellectual property rights in China, which is highly efficient and safe. It is of great value to combine Tislelizumab with ablation to reduce the risk of recurrence in HCC patients. In this study, early-stage HCC patients with high risk of recurrence would be included and randomly assigned to receive ablation plus Tislelizumab or ablation alone. The tumor recurrence, overall survival and safety would be observed and recorded to analyze whether Tislelizumab can reduce the recurrence rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
200mg, iv. drip, Q3W. Tislelizumab will start within 3-7 days after ablation treatment. The longest course of treatment is 12 months.
After local anesthesia and intravenous sedative injection, the unipolar needle would be gradually inserted into the lesion and placed on the deepest edge of the lesion. The ablation electrode is a unipolar needle with a bare end of 2 or 3 cm (adjusted to tumor size). The ablation power is 150 watts (range from 100 to 200 watts). In general, the average ablation time for each lesion is about 12 minutes (ranging from 10 to 15 minutes).
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, China
RECRUITING1-year recurrence-free survival (RFS) rate
It is defined as the percentage of patients who achieve a time interval of 1 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment, whichever occurs first.
Time frame: 1 year
2-year recurrence-free survival (RFS) rate
It is defined as the percentage of patients who achieve a time interval of 2 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment.
Time frame: 2 years
3-year recurrence-free survival (RFS) rate
It is defined as the percentage of patients who achieve a time interval of 3 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment.
Time frame: 3 years
Overall survival (OS)
It is defined as the time from date of randomization to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates.
Time frame: 3 years
Time to Recurrence (TTR)
It is defined as the time between the date of enrollment and the date of first recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis).
Time frame: From date of randomization up to 5 years, approximately
Safety of ablation and ablation plus Tislelizumab
Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in all treated patients.
Time frame: From date of randomization up to 5 years, approximately
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Biomarkers in tumor and peripheral blood to evaluate association with clinical efficacy and/or incidence of AEs.
Correlation of selected biomarkers with efficacy (RFS rate and OS) and safety (incidence of AEs) endpoints.
Time frame: From date of randomization up to 5 years, approximately
Evaluate the patient's cancer-related QoL using the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ), the EORTC QLQ-C30 and the EORTC QLQ-HCC18.
Change in sub-scale and total scores of EORTC QLQ-C30 and EORTC QLQ- HCC18 from baseline through follow-up.
Time frame: From date of randomization up to 5 years, approximately