HCCPTA4HCCNCT06008548
A New Conception About Individualized Treatment Allocation for HCC
An observational study of HCC and Transarterial Chemoembolization, run by Tang-Du Hospital.
Trial summary
The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HCC, Transarterial Chemoembolization, Resection
- What is being tested?
- TACE
- Type of treatment
- Surgery or procedure
- How many people
- 4,991 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Oct 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was diagnosed based on either imaging or pathological results as previously described
Who may be able to join
- Diagnosed with HCC
- Receiving LR or TACE therapy
- Complete clinical information
- Preserved liver function (Child-Pugh Score [CPS] ≤ 7)
- PS 0-1
Who cannot join
- Vascular invasion or extrahepatic spread;
- Ecompensated liver cirrhosis ;
- Younger than 18 years;
- Duration of follow-up of fewer than 30 days.
About this study
Official title: A New Conception About Individualized Treatment Allocation for HCC-Using Machine Learning
The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients allocated to different treatments.
Read the detailed description
Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE were included in the study. Various prognostic AI algorithms were modeled using data from a large multi-institutional cohort, where LR and TACE were considered independent factors. The C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC) were calculated to estimate the AI models.
- Conditions
- HCC, Transarterial Chemoembolization, Resection
- Being tested
- TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TACE group | Incorporated HCC patients underwent TACE therapy. Receives: Procedure: TACE | |
| Liver resection group | Incorporated HCC patients underwent liver resection therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival (OS) was defined as the time interval between initial TACE or LR and all-cause death. Patients who survived up to the last follow-up date
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jan 2010
- Primary completion30 Jan 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,991 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Army Medical University, China, The First Affiliated Hospital of Shanxi Medical University, Sun Yat-sen University, Shaanxi Provincial People's Hospital, Xijing Hospital, Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Lei Liu, doctor, Study director, The Second Affiliated Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008548
- Sponsor's protocol ID
- liulei
- Acronym
- PTA4HCC
- Status last verified
- Aug 2023
- First submitted
- 2 Apr 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Conception About Individualized Treatment Allocation for HCC-Using Machine Learning
- ClinicalTrials.gov ID
- NCT06008548
- Acronym / sponsor ID
- PTA4HCC / liulei
- Conditions
- HCC, Transarterial Chemoembolization, Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,991 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Army Medical University, China, The First Affiliated Hospital of Shanxi Medical University, Sun Yat-sen University, Shaanxi Provincial People's Hospital, Xijing Hospital, Xi'an Jiaotong University
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 23 Aug 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.
The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients allocated to different treatments.
Detailed description
Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE were included in the study. Various prognostic AI algorithms were modeled using data from a large multi-institutional cohort, where LR and TACE were considered independent factors. The C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC) were calculated to estimate the AI models.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE group | – | Procedure: TACEIncorporated HCC patients underwent TACE therapy. |
| Liver resection group | – | –Incorporated HCC patients underwent liver resection therapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was diagnosed based on either imaging or pathological results as previously described
Key inclusion criteria (5 listed)
- Diagnosed with HCC
- Receiving LR or TACE therapy
- Complete clinical information
- Preserved liver function (Child-Pugh Score [CPS] ≤ 7)
- PS 0-1
Key exclusion criteria (4 listed)
- Vascular invasion or extrahepatic spread;
- Ecompensated liver cirrhosis ;
- Younger than 18 years;
- Duration of follow-up of fewer than 30 days.
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 |
|---|---|---|
| TACE | Procedure or surgery | TACE group |
Primary outcome
overall survival
Time frame: 5 years
Overall survival (OS) was defined as the time interval between initial TACE or LR and all-cause death. Patients who survived up to the last follow-up date
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 23 Aug 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.
Lei Liu, doctor study director
The Second Affiliated Hospital of Air Force Military Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of HCC and Transarterial Chemoembolization, run by Tang-Du 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 5 inclusion and 4 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 23 Aug 2023. 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?
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: 5 years). 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 23 Aug 2023.