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Trial Title:
To Evaluate the Performance of HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy on Unresectable Colorectal Liver Metastases
NCT ID:
NCT05889325
Condition:
Colorectal Liver Metastases (CRCLM)
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
DEB-TACE plus HAIC
Description:
the patients received HepaSphere DEB-TACE plus HAIC
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
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Xu Zhu
Phone:
13501146178
Email:
drzhuxu@163.com
Contact backup:
Last name:
Aiwei Feng
Phone:
18643411808
Email:
ivyfeng_1026@163.com
Start date:
July 1, 2023
Completion date:
November 2023
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889325
