Estimation and Prediction of Individual Benefit From Postoperative Adjuvant Transcatheter Arterial Chemoembolization For Patients With Hepatocellular Carcinoma

Adjuvant transarterial chemoembolization (TACE) is widely adopted in China for resectable hepatocellular carcinoma (HCC), yet its efficacy remains inconsistent. We aimed to identify factors influencing individual patient benefit using causal machine learning. To this end, we retrospectively collected HCC patients with high risk factors for tumor recurrence from four centers of China, divided into the discovery cohort and the validation cohort . The primary endpoint was disease-free survival (DFS). The primary endpoint was overall survival (OS).Individual treatment effects (ITEs) were estimated within a causal machine learning framework. An ITE < 0 was considered recommendation for adjuvant TACE , while ITE ≥ 0 indicated active surveillance. The model would be validated in the validation cohort. The contribution of each variable to ITE was assessed using the Shapley Additive Explanations (SHAP). An online calculator would be developed for future use by public.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Adjuvant Therapy Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Machine Learning Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Transarterial Chemoembolization Treatment Effectiveness

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of USTC

Hefei, Anhu, 23000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) pathologic diagnosis of HCC; (2) received potentially curative hepatectomy with negative cut margins confirmed by pathology; (3) high risk of recurrence, meeting any of the following criteria: largest tumor >5 cm, multiple lesions, poor histological differentiation (Edmondson-Steiner grade III or IV), presence of microvascular invasion or satellite nodules, (4) received adjuvant TACE or active surveillance as postoperative treatment; (5) at least one year of follow-up.

Exclusion criteria

(1) history of other malignancies; (2) received preoperative anti-tumor treatment; (3) presence of vascular invasion or extrahepatic metastasis; (4) tumor recurred within 4 weeks postoperatively; (5) residual tumor was detected by digital subtraction angiography (DSA); (6) received other types of adjuvant therapy; (7) cases with missing data exceeding 10%.

Treatment and study plan

Primary outcomes

Disease free survival

Time frame: From January 2018 to December 2023

Disease-free survival (DFS) was defined as the time from the date of curative-intent HCC surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause, whichever came first. Patients without any of these events were censored at the last follow-up.

Secondary outcomes

Overall survival

Time frame: From January 2018 to December 2023

Overall Survival (OS) was defined as the time from the date of curative-intent HCC surgery to the first occurrence of death from any cause. Patients who were still alive at the last follow-up were censored at the date of the last follow-up.

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Collaborators

Affiliated Hospital of Qinghai University
Anhui Provincial Cancer Hospital
No.2 People's Hospital of Fuyang City
Sun Yat-Sen University Cancer Center
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Acronym: HCC

Important dates

Study start: 2018
Primary completion: 2025
Study completion: 2025
First posted: May 1, 2026
Registry last updated: Jul 9, 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.

Published trials that share one or more normalized conditions with this study.

Completed