Estimation and Prediction of Individual Benefit From Postoperative Adjuvant Transcatheter Arteria… (NCT07562763) | Clinical Trial Compass
CompletedNot Applicable
Estimation and Prediction of Individual Benefit From Postoperative Adjuvant Transcatheter Arterial Chemoembolization For Patients With Hepatocellular Carcinoma
China1,005 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%.
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.