NCT07483242

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 8, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment Effects

    5-year overall survival (OS)

    2025.09.01

Study Arms (2)

Bile Duct Resection (BDR) group

Procedure: Bile Duct Resection

Non-Bile Duct Resection (NBDR) group

Interventions

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

Bile Duct Resection (BDR) group

Eligibility Criteria

Age31 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China, Guangdong

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 19, 2026

Study Start

August 1, 2024

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations