Colorectal Liver Metastases (CRCLM)
Conditions
Brief 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
Interventions
PROCEDUREDEB-TACE plus HAIC
the patients received HepaSphere DEB-TACE plus HAIC
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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 |
| Objective Response Rate (ORR) | 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 |
| Duration of Response (DoR) | 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 |
Countries
China
Contacts
Primary ContactXu Zhu, M.D
Backup ContactAiwei Feng, M.D
Outcome results
None listed