Hepatocellular Carcinoma (HCC)NCT07483242
Individualized Surgical Guidance in HCC-BDTT
An observational study of Hepatocellular Carcinoma (HCC), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The Rboost causal model can identify patients who are most likely to benefit among HCC-BDTT patients. Adherence to the individualized recommendation improves survival. This data-driven tool offers vital support for precision surgical decision-making in this high-risk disease. Read more about this study
- Who is it for?
- Ages 31 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Bile Duct Resection
- Type of treatment
- Surgery or procedure
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Aug 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 31 to 80 years
- All sexes
- Adult, Older adult
Study population: This dual-center observational study was approved by the Institutional Review Board (IRB) of the First Affiliated Hospital of Sun Yat-sen University (approval number: [2023]016), with a waiver of informed consent. This study retrospectively enrolled patients with HCC from two campuses: Yuexiu campus (Center 1; January 2011-August 2020) and Huangpu campus (Center 2; August 2014-August 2020).
Who may be able to join
- Pathologically confirmed HCC with BDTT;
- Absence of extrahepatic malignancies at the time of HCC diagnosis;
- Undergone R0 curative hepatectomy;
- No prior antitumor therapies, such as chemotherapy or immunotherapy, before surgery;
- Availability of preoperative imaging (CT or MRI) with standardized tumor evaluation.
Who cannot join
- Pathological findings indicating concurrent cholangiocarcinoma and HCC;
- Loss to follow-up, preventing outcome evaluation, or insufficient clinical data for analysis.
- Significant comorbidities (e.g., severe cardiac or renal failure) that could affect surgical outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Surgical Guidance for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Causal Modeling Study Integrating Preoperative Imaging and Clinical Features
The Rboost causal model can identify patients who are most likely to benefit among HCC-BDTT patients. Adherence to the individualized recommendation improves survival. This data-driven tool offers vital support for precision surgical decision-making in this high-risk disease.
Read the detailed description
This dual-center study recruited 151 HCC-BDTT patients who underwent radical hepatectomy (training cohort: 92; validation cohort: 59). An XGBoost-based R-learner (Rboost) algorithm was developed to estimate the individualized treatment effect (ITE) on 5-year overall survival (OS) between BDR and NBDR. Patients were stratified into ITE tertiles: BDR-recommended, ambiguous benefit, and NBDR-recommended. Model performance assessed with heterogeneity metrics (C-for-benefit, adjusted Qini index). Survival outcomes were compared within ITE strata between surgeries concordant and discordant with model recommendations (Kaplan-Meier/log-rank). Two-year disease-free survival (DFS) served as a treatment-proximal validity check.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Bile Duct Resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bile Duct ResectionProcedure or surgery
This group includes biliary/enteric reconstruction, bile duct resection with thrombectomy, and biliary tract interventions
| Study group | Role | What they receive |
|---|---|---|
| Bile Duct Resection (BDR) group | Not described Receives: Procedure: Bile Duct Resection | |
| Non-Bile Duct Resection (NBDR) group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effects
5-year overall survival (OS)
Measured: 2025.09.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Aug 2024
- Primary completion1 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Danyang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483242
- Sponsor's protocol ID
- SYSUFAH20251021
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All primary data are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Surgical Guidance for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Causal Modeling Study Integrating Preoperative Imaging and Clinical Features
- ClinicalTrials.gov ID
- NCT07483242
- Acronym / sponsor ID
- SYSUFAH20251021
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 19 Mar 2026 (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 Rboost causal model can identify patients who are most likely to benefit among HCC-BDTT patients. Adherence to the individualized recommendation improves survival. This data-driven tool offers vital support for precision surgical decision-making in this high-risk disease.
Detailed description
This dual-center study recruited 151 HCC-BDTT patients who underwent radical hepatectomy (training cohort: 92; validation cohort: 59). An XGBoost-based R-learner (Rboost) algorithm was developed to estimate the individualized treatment effect (ITE) on 5-year overall survival (OS) between BDR and NBDR. Patients were stratified into ITE tertiles: BDR-recommended, ambiguous benefit, and NBDR-recommended. Model performance assessed with heterogeneity metrics (C-for-benefit, adjusted Qini index). Survival outcomes were compared within ITE strata between surgeries concordant and discordant with model recommendations (Kaplan-Meier/log-rank). Two-year disease-free survival (DFS) served as a treatment-proximal validity check.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bile Duct Resection (BDR) group | – | Procedure: Bile Duct Resection |
| Non-Bile Duct Resection (NBDR) group | – | – |
Who may qualify
- Ages
- 31 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This dual-center observational study was approved by the Institutional Review Board (IRB) of the First Affiliated Hospital of Sun Yat-sen University (approval number: [2023]016), with a waiver of informed consent. This study retrospectively enrolled patients with HCC from two campuses: Yuexiu campus (Center 1; January 2011-August 2020) and Huangpu campus (Center 2; August 2014-August 2020).
Key inclusion criteria (5 listed)
- Pathologically confirmed HCC with BDTT;
- Absence of extrahepatic malignancies at the time of HCC diagnosis;
- Undergone R0 curative hepatectomy;
- No prior antitumor therapies, such as chemotherapy or immunotherapy, before surgery;
- Availability of preoperative imaging (CT or MRI) with standardized tumor evaluation.
Key exclusion criteria (3 listed)
- Pathological findings indicating concurrent cholangiocarcinoma and HCC;
- Loss to follow-up, preventing outcome evaluation, or insufficient clinical data for analysis.
- Significant comorbidities (e.g., severe cardiac or renal failure) that could affect surgical outcomes.
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 |
|---|---|---|
| Bile Duct ResectionThis group includes biliary/enteric reconstruction, bile duct resection with thrombectomy, and biliary tract interventions | Procedure or surgery | Bile Duct Resection (BDR) group |
Primary outcome
Treatment Effects
Time frame: 2025.09.01
5-year overall survival (OS)
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 19 Mar 2026.
- Individual participant dataSharing planned: Undecided. All primary data are available from the corresponding author upon reasonable request.
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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.
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 Hepatocellular Carcinoma (HCC), run by First Affiliated Hospital, Sun Yat-Sen University 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 5 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: finished, as of the sponsor's last update on 19 Mar 2026. 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?
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?
Treatment Effects (time frame: 2025.09.01). 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 19 Mar 2026.