Carcinoma, HepatocellularNCT05352204
Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas
An observational study of Carcinoma, Hepatocellular, run by Zhejiang University at 2 sites in China.
Trial summary
Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- transcatheter arterial chemoembolization
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 2 sitesChina
- Study dates
- 30 Apr 2020to 14 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From June 2014 to April 2018, HCC patients who underwent liver resection in our center were retrospectively reviewed.
Who may be able to join
- (1) pathologically confirmed HCC (2) achievement of R0 resection.
Who cannot join
- (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.
Trial locations and contacts
2 sites in 1 country.
China2 sites
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: The Guiding Value of Tumor Micronecrosis for Using Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas
Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- transcatheter arterial chemoembolization
- Keywords
- hepatocellular carcinoma, TACE, tumor necrosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter arterial chemoembolizationProcedure or surgery
transcatheter arterial chemoembolization after liver resection
| Study group | Role | What they receive |
|---|---|---|
| micronecrosis(+) group | Not described Receives: Procedure: transcatheter arterial chemoembolization | |
| micronecrosis(-) group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
Measured: after liver resection until June 1, 2020
Secondary outcomes (1)
disease-free survival
the number of months from the date of surgery to the date of first confirmable recurrence or death
Measured: after liver resection until June 1, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start30 Apr 2020
- Primary completion1 Jan 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352204
- Sponsor's protocol ID
- PTHCC
- Status last verified
- Feb 2023
- First submitted
- 22 Apr 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Guiding Value of Tumor Micronecrosis for Using Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas
- ClinicalTrials.gov ID
- NCT05352204
- Acronym / sponsor ID
- PTHCC
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- hepatocellular carcinoma, TACE, tumor necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 28 Apr 2022 (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.
Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micronecrosis(+) group | – | Procedure: transcatheter arterial chemoembolization |
| micronecrosis(-) group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From June 2014 to April 2018, HCC patients who underwent liver resection in our center were retrospectively reviewed.
Key inclusion criteria (1 listed)
- (1) pathologically confirmed HCC (2) achievement of R0 resection.
Key exclusion criteria (1 listed)
- (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.
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 |
|---|---|---|
| transcatheter arterial chemoembolizationtranscatheter arterial chemoembolization after liver resection | Procedure or surgery | micronecrosis(+) group |
Primary outcome
overall survival
Time frame: after liver resection until June 1, 2020
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
1 secondary outcome
disease-free survival
Time frame: after liver resection until June 1, 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Zhejiang University at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: after liver resection until June 1, 2020). 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 14 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.