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Not yet recruitingNCT05889325Updated Jun 5, 2023

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

An observational study in Colorectal Liver Metastases (CRCLM), sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Peking University Cancer Hospital & Institute · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Colorectal Liver Metastases (CRCLM)
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 100 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedureDEB-TACE plus HAIC

    the patients received HepaSphere DEB-TACE plus HAIC

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What researchers measure

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

    Time frame: Up to 3 years

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival is defined as the time from the start of treatment with HepaSphere DEB-TACE plus HAIC until death due to any cause

    Time frame: Up to 3 years

  2. Objective Response Rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1

    Time frame: Up to 3 years

  3. Duration of Response (DoR)

    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

    Time frame: Up to 3 years

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05889325
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Sep 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Jun 5, 2023

Study contacts

Xu Zhu, M.D
Contact
drzhuxu@163.com
+8613501146178
Aiwei Feng, M.D
Contact
ivyfeng_1026@163.com
86-18643411808

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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