The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
For the first 6 patients in the safety lead-in period, the starting dose of epalrestat was 50 mg, three times per day. If dose-limiting toxicity (DLT) occurred in the first 6 patients, the dose for the second round of 6 patients in the safety lead-in period would be adjusted to 50 mg, twice per day. If DLT occurred in the second round of 6 patients, the dose for the third round of 6 patients in the safety lead-in period would be adjusted to 50 mg, once per day.
donafenib 0.2g BID, tislelizumab 200mg/21days
Include FOLFOX and RALOX.
The First Hospital of China Medical University
Shenyang, Liaoning, China
12-month Event-free survival (EFS) Rate
The proportion of patients who have remained event-free from the start of treatment until the 12-month time point.(Predefined events include: progression of disease, death for any reason, terminate the treatment due to intolerable AEs.)
Time frame: From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.
Event-free survival (EFS)
Defined as the time from treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs).
Time frame: From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.
Overall survival (OS)
The OS is defined as the time from the enrollment to death due to any cause.
Time frame: Up to approximately 2 years
Progression free survival(PFS) (Overall)
The PFS is defined as the time from the enrollment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame: From enrollment to progressive disease (according to mRECIST) or death due to any cause, up to 2 years.
Progression free survival(PFS) of intra-hepatic lesions
The PFS is defined as the time from the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.
Time frame: From the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, up to 2 years.
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Progression free survival(PFS) of extra-hepatic lesions
The PFS is defined as the time from the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.
Time frame: From the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, up to 2 years.
Objective response rate(ORR) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Time frame: Up to approximately 2 years
ORR per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Time frame: Up to approximately 2 years
PVTT response rate per mRECIST
The PVTT response rate is defined as the proportion of patients with a documented CR or PR of PVTT. According to the Vp classification: CR: PVTT disappears or the portal vein becomes completely unobstructed. PR: Decrease in VP classification. SD: Without PR and PD. PD: Increase in VP classification.
Time frame: Up to approximately 2 years
Disease control rate(DCR) per RESCIST 1.1
The DCR is defined as the proportion of patients with a documented complete response(CR), partial response(PR) or stable disease(SD) per RECIST 1.1.
Time frame: Up to approximately 2 years
DCR per mRECIST
The DCR is defined as the proportion of patients with a documented complete response(CR), partial response(PR) or stable disease(SD) per mRECIST.
Time frame: Up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Time frame: Up to approximately 2 years