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

NCT ID: NCT05889325

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-11-30

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

Detailed Description

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Conditions

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Colorectal Liver Metastases (CRCLM)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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DEB-TACE plus HAIC

the patients received HepaSphere DEB-TACE plus HAIC

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xu Zhu, M.D

Role: CONTACT

+8613501146178

Aiwei Feng, M.D

Role: CONTACT

86-18643411808

Facility Contacts

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Xu Zhu

Role: primary

13501146178

Aiwei Feng

Role: backup

18643411808

Other Identifiers

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CRCLM-HEPA-HAIC-001

Identifier Type: -

Identifier Source: org_study_id

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