Adjuvant Therapy, Hepatocellular Carcinoma (HCC), Machine Learning, Transarterial Chemoembolization, Treatment Effectiveness
Conditions
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.
Interventions
None listed
Sponsors
Anhui Provincial Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sun Yat-Sen University Cancer Center
No.2 People's Hospital of Fuyang City
Affiliated Hospital of Qinghai University
Anhui Provincial Cancer Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLianxin Liu, Ph.D.
The First Affiliated Hospital of USTC
Outcome results
None listed