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Trial Title:
The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
NCT ID:
NCT05862181
Condition:
Advanced Hepatocellular Carcinoma (HCC)
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
HepaSphere
Transarterial chemoembolization
TACE
Hepatic Arterial Infusion Chemotherapy
HAIC
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
DEB-TACE plus HAIC or HAIC alone
Description:
the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational
study
Arm group label:
HAIC group
Arm group label:
HEPA-HAIC group
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
Criteria for eligibility:
Study pop:
all of patients were diagnosed as HCC. Some of them may received the treatment before
enrollment. They only received HepaSphere plus HAIC or HAIC alone as the interventional
therapy during this study.
Sampling method:
Non-Probability Sample
Criteria:
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
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
Status:
Recruiting
Contact:
Last name:
Xu Zhu, M.D
Phone:
0086-10-88196330
Email:
drzhuxu@163.xom
Investigator:
Last name:
Xu Zhu, M.D
Email:
Principal Investigator
Start date:
January 1, 2023
Completion date:
December 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/NCT05862181
