NCT07562763Completed
Estimation and Prediction of Individual Benefit From Postoperative Adjuvant Transcatheter Arterial Chemoembolization For Patients With Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1005 (actual)
- First submitted
- 26 Apr 2026
- Start date
- 1 Jan 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07562763
What you commit to
- Study type: Observational
- Participants enrolled: 1005
- From 1 Jan 2018 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- (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%.
Who the study is looking for
- (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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of USTC Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.