Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .

Detailed Description
-----------------
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. The purpose of this study is to evaluate the safety and efficacy of TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.

Official Title
-----------------
Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: TACE+ICIs
* Procedure: TACE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with HCC by radiology, histology, or cytology; patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received; during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group; patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy. Exclusion Criteria: exceeding the time interval of the combination therapy defined above; missing follow-up data;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group: TACE+ICIs<br>TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); ICIs: atezolizumab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab or other ICIs | Other: TACE+ICIs<br>* TACE plus ICIs ( with or without molecular targeted therapies)<br>|
| Control group: TACE<br>TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); | Procedure: TACE<br>* TACE without combination of ICIs ( with or without molecular targeted therapies)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival(PFS) | The PFS is defined as the time from the initiation of any combination treatment to progression according to mRECIST or death from any cause. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy). | up to approximately 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) | The OS is defined as the time from the initiation of any combination treatment to death from any cause. | up to approximately 2 years | 
| Time to Progression(TTP) | The TTP is defined as the time from the initiation of any combination treatment to progression according to mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm. | up to approximately 1 years | 
| Objective response rate(ORR) | The ORR is defined as the proportion of patients with a documented complete response or partial response per mRECIST. | 6-8 week after TACE | 
| Disease control rate(DCR) | The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST. | 6-8 week after TACE | 
| Adverse event(AE) | Number and degree of the AEs according to CTCAE version 5.0. | baseline to end of study (approximately 2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
real-world study, hepatocellular carcinoma, transarterial chemoembolization, immune checkpoint iInhibitors