Advanced Hepatocellular Carcinoma (HCC)NCT05862181
The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
An observational study of Advanced Hepatocellular Carcinoma (HCC), run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- DEB-TACE plus HAIC or HAIC alone
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xu Zhu, M.D, 0086-10-88196330, drzhuxu@163.xom
Xu Zhu, M.D
About this study
Official title: Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
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
Read the 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
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- DEB-TACE plus HAIC or HAIC alone
- Keywords
- HepaSphere, Transarterial chemoembolization, TACE, Hepatic Arterial Infusion Chemotherapy, HAIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACE plus HAIC or HAIC aloneProcedure or surgery
the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study
| Study group | Role | What they receive |
|---|---|---|
| HEPA-HAIC group | HEPA-HAIC group is composed of advanced HCC patients treated with HepaSphere DEB-TACE combined with HAIC as the interventional therapy Receives: Procedure: DEB-TACE plus HAIC or HAIC alone | |
| HAIC group | HAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy Receives: Procedure: DEB-TACE plus HAIC or HAIC alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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
Measured: Up to 3 year
Overall Survival (OS)
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
Measured: Up to 3 year
Secondary outcomes (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
Measured: Up to 3 year
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
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jan 2023
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862181
- Sponsor's protocol ID
- HCC-HEPA-HAIC-001
- Status last verified
- Mar 2023
- First submitted
- 8 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05862181
- Acronym / sponsor ID
- HCC-HEPA-HAIC-001
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Keywords
- HepaSphere, Transarterial chemoembolization, TACE, Hepatic Arterial Infusion Chemotherapy, HAIC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEPA-HAIC group | – | Procedure: DEB-TACE plus HAIC or HAIC aloneHEPA-HAIC group is composed of advanced HCC patients treated with HepaSphere DEB-TACE combined with HAIC as the interventional therapy |
| HAIC group | – | Procedure: DEB-TACE plus HAIC or HAIC aloneHAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEB-TACE plus HAIC or HAIC alonethe patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study | Procedure or surgery | HAIC group, HEPA-HAIC group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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)
Time frame: 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
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 3 year
Duration of Response (DoR)
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Hepatocellular Carcinoma (HCC), run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Zhu, M.D (86-13501146178, drzhuxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.