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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 596 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Zhongda Hospital is the lead sponsor of 104 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with advanced HCC who received Tislelizumab and Lenvatinib with/without TACE under real-world practice conditions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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；
This study also gives Lenvatinib. No intervention listed here names it: that was found by reading the record.
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
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
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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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