An observational study in Hepatocellular Carcinoma (HCC), sponsored by Zhongda Hospital. Not yet recruiting at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Zhongda Hospital · Observational
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with Tislelizumab and Lenvatinib in patients with advanced-stage hepatocellular carcinoma (HCC).
Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. Tislelizumab is a PD-1 monoclonal antibody approved by the National Medical Products Administration (NMPA) of China for first-line and second-line treatment of patients with HCC. The purpose of this real-world study is to evaluate the safety and efficacy of TACE in combination with Tislelizumab and Lenvatinib in patients with advanced-stage HCC.
Patients with advanced HCC who received Tislelizumab and Lenvatinib with/without TACE under real-world practice conditions.
Exclusion Criteria:
TACE + Tislelizumab + Lenvatinib TACE was performed within 3 months before or after the first Tislelizumab /Lenvatinib treatment. The interval between first use Tislelizumab and Lenvatinib ≤1 week；
Tislelizumab + Lenvatinib The interval between first use Tislelizumab and Lenvatinib ≤1 week；
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Time frame: up to approximately 2 years
Progression free survival(PFS) per RECIST 1.1
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years
PFS per mRECIST
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame: up to approximately 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
Duration of Response (DOR) per RESCIST 1.1
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 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
DOR per mRECIST
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years
DCR per mRECIST
DCR is defined as the percentage of participants who have a best overall response of CR, 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
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Zhongda Hospital