RecruitingPhase 1/2

Multimodal Deep Learning for Postoperative Liver Cancer Risk Stratification and Intervention

China144 participantsStarted 2025-10-26

Plain-language summary

This study is for patients with early-stage liver cancer who are planning to have surgery. The goal of this research is to see if a personalized treatment plan, guided by a computer model (an artificial intelligence tool), can help prevent the cancer from coming back after surgery. First, the computer model will analyze each patient's medical images and health data to predict their personal risk of the cancer returning. Patients whom the model predicts have a high risk of the cancer coming back will be offered a special treatment plan. This plan involves receiving medication (neoadjuvant therapy) before surgery and additional medication (adjuvant therapy) after surgery. The effectiveness of this plan will be compared to the standard approach of surgery alone. The main goal is to see if this new, personalized plan can better prevent the cancer from returning within 2 years after surgery. The study will also closely monitor the safety of the medications used. All patients in the study will be followed closely for 2 years with regular scans and check-ups to monitor their health.

Who can participate

Age range

18 Years – 75 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: * Age and Consent: Patients aged 18-75 years who are able to understand and voluntarily sign an Informed Consent Form. * Diagnosis: Clinical diagnosis of BCLC stage 0-A hepatocellular carcinoma, confirmed by histopathology or non-invasive imaging criteria per guidelines. * Surgical Candidacy: Scheduled to undergo curative-intent liver resection. * Risk Stratification: Predicted as high-risk for aggressive recurrence by the pre-operative multimodal deep learning model (PRE score ≥ 0.5). * Liver Function: Child-Pugh liver function class A (score ≤ 7). * Performance Status: ECOG Performance Status of 0 or 1. * Imaging Requirement: Availability of a standard pre-operative MRI scan (including non-contrast, arterial, portal venous, and delayed phases) performed within 1 month prior to enrollment, with acceptable image quality. * Follow-up Commitment: Willing and able to comply with the study procedures and scheduled follow-up for at least 2 years. Exclusion Criteria: * Pathology: Postoperative pathological confirmation of non-HCC malignancy (e.g., cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma). * Other Malignancies: History of other active malignancies within the past 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or other cancers with a very low risk of recurrence. * Early Mortality/Loss: Death from any cause or loss to follow-up within 90 days after surgery. * Contraindications to Protoc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

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?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

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.

What they're measuring

2-year Recurrence-free Survival (RFS) Rate

Timeframe: 2 years post-surgery

Trial details

NCT IDNCT07282184

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Yang Wu, M.D.

+8613636076910 255001907@qq.com

View on ClinicalTrials.gov More Hepotacellular Carcinoma trials