To Evaluate the Performance of HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy on Unresectable Colorectal Liver Metastases

Study Overview
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Brief Summary
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Both drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) are recommended for unresectable colorectal liver metastases (CRLM) treatment. However, the combined application of DEB-TACE and HAIC is not widely accepted. The aim of this single-center retrospective study was to evaluate the efficacy and safety of Irinotecan-eluting HepaSphere chemoembolization combined with HAIC for unresectable CRLM

Official Title
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Efficacy and Safety of Irinotecan-eluting HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy for Unresectable Colorectal Liver Metastases

Conditions
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Colorectal Liver Metastases (CRCLM)

Intervention / Treatment
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* Procedure: DEB-TACE plus HAIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥18 years old Gender: no limitation Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable) Subjects must have at least one measurable lesion per RECIST v1.1 Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) as interventional therapy during the observation period Child-Pugh: A-B ECOG: 0-2. Exclusion Criteria: Other malignant tumors in the past 5 years Drug-eluting beads from other manufacturers were used during DEB-TACE DEB-TACE combined with HAIC was used as postoperative adjuvant therapy Pre- or post-surgery relevant examination results were unavailable Imaging information for effectiveness evaluation was unavailable Follow-up failure due to patient information errors, loss, refusal, etc

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: DEB-TACE plus HAIC|the patients received HepaSphere DEB-TACE plus HAIC|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | Progression-free survival is defined as the time from the start of treatment HepaSphere DEB-TACE plus HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival is defined as the time from the start of treatment with HepaSphere DEB-TACE plus HAIC until death due to any cause | Up to 3 years | 
| Objective Response Rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 | Up to 3 years | 
| Duration of Response (DoR) | Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first | Up to 3 years |