Advanced Hepatocellular Carcinoma (HCC)
Conditions
Keywords
HepaSphere, Transarterial chemoembolization, TACE, Hepatic Arterial Infusion Chemotherapy, HAIC
Brief summary
Transarterial chemoembolization (TACE) is widely applied and shows good efficacy in advanced hepatocellular carcinoma (HCC). Recently, hepatic arterial infusion chemotherapy (HAIC) has also gained popularity in the treatment of HCC. Several studies have described the comparison between HAIC and TACE or TACE combined with HAIC. However, the evaluation between TACE plus HAIC and HAIC is rarely reported. Here, we will evaluate the performance of HepaSphere DEB-TACE combined with HAIC (HEPA-HAIC) comparing to HAIC in patients with advanced HCC
Detailed description
This is a double-arm, retrospective, observational study. The patients diagnosed as advanced HCC and treated with HepaSphere plus HAIC or single HAIC in the interventional therapy department of Peking University Cancer Hospital & Institute from May 2018 to May 2022. These patients are grouped into two cohorts. One is HEPA-HAIC group, the other is HAIC group. To access the effect of HepaSphere plus HAIC and single HAIC on the treatment of advanced HCC, the treatment efficacy and safety will be analyzed between these two cohorts. To avoid the selection bias, Propensity score matching (PSM) will be also conducted. The primary endpoints are progression-free survival (PFS) and overall survival (OS); the secondary endpoint includes objective response rate (ORR), disease control rate (DCR) and safety
Interventions
PROCEDUREDEB-TACE plus HAIC or HAIC alone
the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study
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 * Diagnosed as primary hepatocellular carcinoma histologically or clinically * Imaging data within 31 days at enrollment and at least one measurable lesion (according to mRECIST criteria) is available * Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) or HAIC alone during the observation period * Child-Pugh: A-B * ECOG: 0-2.
Exclusion criteria
* Other cancer diseases are co-existed * Drug-eluting beads from other manufacturers were used during DEB-TACE * DEB-TACE combined with HAIC or HAIC alone 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 year | Progression-free survival is defined as the time from the start of treatment DEB-TACE plus HAIC or HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first |
| Overall Survival (OS) | Up to 3 year | Overall survival is defined as the time from the start of treatment with DEB-TACE plus HAIC or HAIC until death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 3 year | 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 ContactBaojiang Liu, M.D
Outcome results
None listed