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

May 25, 2023 updated by: Peking University Cancer Hospital & Institute

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DoR)
Time Frame: 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
Up to 3 years
Overall Survival (OS)
Time Frame: 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
Up to 3 years
Objective Response Rate (ORR)
Time Frame: 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
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCLM-HEPA-HAIC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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