TACENCT06483594
Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (CHANCE 2407)
An observational study of TACE and HCC - Hepatocellular Carcinoma, run by Shengjing Hospital.
Trial summary
Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TACE, HCC - Hepatocellular Carcinoma, Liver Abscess
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Jun 2025
- 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: HCC patients from hospital interventional wards receiving TACE
Who may be able to join
- Case group inclusion criteria:
- Time period of inclusion: 2009-2023 (15 years)
- Patients with HCC diagnosed by clinical or pathological criteria according to the National Health Commission guidelines for the diagnosis and treatment of primary liver cancer who underwent TACE after surgery and developed postoperative liver abscess.
- Appendix: Diagnostic criteria for liver abscess after TACE:
- Condition 1: CT images show typically low-density lesions with or without air and fluid levels
- Condition 2:
Show all 12Show fewer
- positive blood culture
- Percutaneous drainage or aspiration is purulent or culture-positive
- Symptoms of infection such as fever/chills, accompanied by elevated inflammatory markers such as white blood cell count, C-reactive protein, or procalcitonin.
- Control group inclusion criteria
- Patients with HCC without liver abscess who underwent TACE in the same center within the week of treatment in the case group.
- -
Who cannot join
- <!-- -->
- Clinical and follow-up data were incomplete
- Loss to follow-up
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma : a Retrospective Multicenter Nested Case-control Study (CHANCE 2407)
Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.
- Conditions
- TACE, HCC - Hepatocellular Carcinoma, Liver Abscess
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver abscess formation after TACE for HCC | Not described | |
| Patients without liver abscess after TACE with HCC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether combined targeted therapy was a risk factor for liver abscess formation after TACE.
The targeted treatment of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.
Measured: one year
Whether combined immunotherapy was a risk factor for liver abscess formation after TACE.
The immunotherapy of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.
Measured: one year
Secondary outcomes (1)
Survival time of patients with liver abscess formation after TACE.
Patients with liver abscess formation after TACE were followed up regularly to determine their survival status.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TACEStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Zhongda Hospital, Changzhou No.2 People's Hospital, Tianjin Medical University General Hospital, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Zhihui Chang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483594
- Sponsor's protocol ID
- 2024PS1094K
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma : a Retrospective Multicenter Nested Case-control Study (CHANCE 2407)
- ClinicalTrials.gov ID
- NCT06483594
- Acronym / sponsor ID
- 2024PS1094K
- Conditions
- TACE, HCC - Hepatocellular Carcinoma, Liver Abscess
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Zhongda Hospital, Changzhou No.2 People's Hospital, Tianjin Medical University General Hospital, Huazhong University of Science and Technology
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Jul 2024 (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.
Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with liver abscess formation after TACE for HCC | – | – |
| Patients without liver abscess after TACE with HCC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients from hospital interventional wards receiving TACE
Key inclusion criteria (12 listed)
- Case group inclusion criteria:
- Condition 1: CT images show typically low-density lesions with or without air and fluid levels
- Control group inclusion criteria
- -
Key exclusion criteria (3 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whether combined targeted therapy was a risk factor for liver abscess formation after TACE.
Time frame: one year
The targeted treatment of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.
Whether combined immunotherapy was a risk factor for liver abscess formation after TACE.
Time frame: one year
The immunotherapy of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.
1 secondary outcome
Survival time of patients with liver abscess formation after TACE.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of TACE and HCC - Hepatocellular Carcinoma, run by Shengjing Hospital.
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 12 inclusion and 3 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Zhihui Chang (＋86-18940258437, Changzh@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether combined targeted therapy was a risk factor for liver abscess formation after TACE. (time frame: one 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 3 Jul 2024.