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

NCT05889325 | Unknown

• 1 other identifier: CRCLM-HEPA-HAIC-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Liver Metastases (CRCLM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival (OS)

  Up to 3 years

• Objective Response Rate (ORR)

  Up to 3 years

• Duration of Response (DoR)

  Up to 3 years

Interventions

DEB-TACE plus HAIC PROCEDURE

the patients received HepaSphere DEB-TACE plus HAIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a retrospective observation study. All of the patients included in this study were diagnosed as advanced colorectal carcinoma with unresectable liver metastasis. In additional, they received only HepaSphere DEB-TACE plus HAIC as the interventional therapy in a period of time from 2018 to 2022 . There is no any intervention in this study

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Central Study Contacts

Xu Zhu, M.D

CONTACT

+8613501146178; drzhuxu@163.com

Aiwei Feng, M.D

CONTACT

86-18643411808; ivyfeng_1026@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 5, 2023
• Study Start: July 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)