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

Not yet recruiting

• Conditions: Colorectal Liver Metastases (CRCLM)

• Registration Number: NCT05889325
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05
• Study Start: 2023-07-01
• Primary Completion: 2023-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 3 years	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 3 years	Overall survival is defined as the time from the start of treatment with HepaSphere DEB-TACE plus HAIC until death due to any cause
Objective Response Rate (ORR)	Up to 3 years	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Duration of Response (DoR)	Up to 3 years	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

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China