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OpenTrials
Completed

NCT Number: NCT07483242

Individualized Surgical Guidance in HCC-BDTT

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.

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Key information

Age range

31 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China, Guangdong

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Bile Duct Resection

Procedure

This group includes biliary/enteric reconstruction, bile duct resection with thrombectomy, and biliary tract interventions

Primary outcomes

  1. Treatment Effects

    Time frame: 2025.09.01

    5-year overall survival (OS)

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Individualized Surgical Guidance for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Causal Modeling Study Integrating Preoperative Imaging and Clinical Features

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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