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NCT Number: NCT06008548

A New Conception About Individualized Treatment Allocation for HCC

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.

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Key information

Conditions

HCC Resection Transarterial Chemoembolization

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with HCC
  • Receiving LR or TACE therapy
  • Complete clinical information
  • Preserved liver function (Child-Pugh Score [CPS] ≤ 7)
  • PS 0-1

Exclusion criteria

  • Vascular invasion or extrahepatic spread;
  • Ecompensated liver cirrhosis ;
  • Younger than 18 years;
  • Duration of follow-up of fewer than 30 days.

Treatment and study plan

TACE

Procedure

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Collaborators

  • Air Force Military Medical University, China
  • Army Medical University, China
  • Shaanxi Provincial People's Hospital
  • Sun Yat-sen University
  • The First Affiliated Hospital of Shanxi Medical University
  • Xi'an Jiaotong University
  • Xijing Hospital

Registry information

Official study title

A New Conception About Individualized Treatment Allocation for HCC-Using Machine Learning

Acronym: PTA4HCC

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2023
Registry last updated
Aug 23, 2023

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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