An observational study in Hepatocellular Carcinoma, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Fudan University · Observational
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in Patients with Advanced Hepatocellular Carcinoma treated with TACE Combined with PD-1 Inhibitor.
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in Patients with Advanced Hepatocellular Carcinoma treated with TACE Combined with PD-1 Inhibitor. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.
3,180 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 752 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in Patients with Advanced Hepatocellular Carcinoma treated with TACE Combined with PD-1 Inhibitor.
Exclusion Criteria:
Drug: PD-1 inhibitor · Procedure: TACE
An approved agent (e.g., Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, etc.) will be selected based on clinical practice and administered at standard doses and schedules.
TACE is performed by using embolic agent combined with Lipiodol-pirarubicin emulsion per Investigator decision
Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.
Time frame: max 24 months
Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (S.D)
Time frame: max 24 months
Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment.
Time frame: max 24 months
Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed
Time frame: max 24 months
Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)
Time frame: max 24 months
Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death
Time frame: max 42 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
Time frame: max 42 months
Translational study
Proportion of different immune cell types in tumors based on single-cell RNA sequencing between two groups.
Time frame: max 42 months
Plan to share: No
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Fudan University