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

P

Peking University Cancer Hospital & Institute

Status

Not yet enrolling

Conditions

Colorectal Liver Metastases (CRCLM)

Treatments

Procedure: DEB-TACE plus HAIC

Study type

Observational

Funder types

Other

Identifiers

NCT05889325
CRCLM-HEPA-HAIC-001

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Xu Zhu, M.D; Aiwei Feng, M.D

Data sourced from clinicaltrials.gov

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