A New Conception About Individualized Treatment Allocation for HCC

HCC Clinical Trial

— PTA4HCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06008548
• Other study ID #: liulei
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: October 1, 2021

Study information

• Verified date: August 2023
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4991
• Est. completion date: October 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• HCC
• Resection
• Transarterial Chemoembolization

Intervention

Procedure:
• TACE

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Tang-Du Hospital	Air Force Military Medical University, China, Army Medical University, Health Science Center of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Sun Yat-sen University, The First Affiliated Hospital of Shanxi Medical University, Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years