This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with sorafenib and tislelizumab in patients with advanced hepatocellullar carcinoma (HCC).
This is a Phase II study to evaluate the efficacy and safety of TACE combined with sorafenib and tislelizumab in patients with advanced HCC. 30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer \[BCLC\] stage C, or China liver cancer staging \[CNLC\] IIIa and IIIb) will be enrolled in the study. Both sorafenib (400mg P.O. Bid) and tislelizumab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination. Sorafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sorafenib administration will be delayed in cases of grade ≥2 hand-foot syndrome, grade \>3 hematologic toxicities or grade ≥3 hypertension. After recovery, sorafenib will be reintroduced at a reduced dose according the sorafenib dose delay and reduction guidelines. Treatment of tislelizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have sorafenib or tislelizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sorafenib (400mg P.O. Bid) and tislelizumab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of tislelizumab will last up to 24 months. Patients will be allowed to have sorafenib or tislelizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
The 2nd Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause.
Time frame: 24 months
Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Time frame: 24 months
Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST).
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 24 months
Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST.
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Time frame: 24 months
Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST.
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).
Time frame: 24 months
Duration of response (DOR) assessed by investigators according to RECIST 1.1 and irRECIST.
The time from the first occurrence of a documented objective response to disease progression (PD) or death.
Time frame: 24 months
PFS assessed by investigators according to Modified RECIST (mRECIST).
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The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 24 months
ORR assessed by investigators according to mRECIST.
The percentage of patients who had a best overall tumor response rating of CR or PR.
Time frame: 24 months
DCR assessed by investigators according to mRECIST.
The percentage of patients who had a tumor response rating of CR, PR, or SD.
Time frame: 24 months
DOR assessed by investigators according to mRECIST.
The time from the first occurrence of a documented objective response to PD or death.
Time frame: 24 months