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

NCT07562763 | Completed

• 1 other identifier: PA-TACE-ITE
• Study Type: observational
• Target: 1,005
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adjuvant Therapy; Hepatocellular Carcinoma (HCC); Transarterial Chemoembolization; Machine Learning; Treatment Effectiveness

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  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.

  From January 2018 to December 2023

Secondary Outcomes (1)

• Overall survival

  From January 2018 to December 2023

Study Arms (4)

Discovery cohort

The cohort is used for training of the causal machine learning model

Validation cohort

The cohort is used for validation of the causal machine learning model

Adjuvant Tace Group

Patients who received adjuvant TACE as postoperative treatment

Active Surveillance Group

Patients who received active surveillance as postoperative treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCC patients with high-risk factors of tumor relapse, who received adjuvant TACE or active postoperative survelliance as treatment.

You may qualify if:

• (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.

You may not qualify if:

• (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%.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of USTC

Hefei, Anhu, 23000, China

Location

Related Publications (3)

• Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.

  PMID: 29420221 BACKGROUND

• Wei W, Jian PE, Li SH, Guo ZX, Zhang YF, Ling YH, Lin XJ, Xu L, Shi M, Zheng L, Chen MS, Guo RP. Adjuvant transcatheter arterial chemoembolization after curative resection for hepatocellular carcinoma patients with solitary tumor and microvascular invasion: a randomized clinical trial of efficacy and safety. Cancer Commun (Lond). 2018 Oct 10;38(1):61. doi: 10.1186/s40880-018-0331-y.

  PMID: 30305149 BACKGROUND

• Ma T, Bai X, Zhang Q, Chen W, Huang K, Qian T, Xu Y, Sun P, Chen Y, Xiao W, Sun K, Gao S, Liang T. Adjuvant transarterial chemoembolization for hepatocellular carcinoma following curative resection: A randomized, open-label, phase 3 trial. Hepatology. 2025 Nov 1;82(5):1112-1121. doi: 10.1097/HEP.0000000000001233. Epub 2025 Jan 14.

  PMID: 39808820 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

FFPE and frozen tumor samples were obtained from the biobank of the First Affiliated Hospital of University of Science and Technology of China for hematoxylin and eosin (HE) staining, Oil Red O staining, and immunohistochemistry staining.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lianxin Liu, Ph.D.

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: January 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)