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.
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).
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 Protocol Therapy: Known hypersensitivity to any component of the neoadjuvant therapy regimen (e.g., oxaliplatin, fluorouracil, PD-1 inhibitors, lenvatinib).
Parallel
Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor
Combination productA combination drug regimen used as neoadjuvant therapy. Includes Hepatic Arterial Infusion Chemotherapy (HAIC) with mFOLFOX6 (Oxaliplatin, Leucovorin, Fluorouracil), oral Lenvatinib, and an intravenous PD-1 inhibitor.
Curative Liver Resection
Procedure/SurgeryStandard anatomic or non-anatomic liver resection with the intention of achieving complete tumor removal with negative margins. This is the standard surgical procedure for resectable hepatocellular carcinoma
Multimodal AI Risk Stratification
Other interventionThe use of a pre-established deep learning model (PRE/POST model) to analyze preoperative imaging and clinical data to stratify patients' risk of aggressive recurrence. This stratification is used to determine treatment arm assignment.
2-year Recurrence-free Survival (RFS) Rate
The primary outcome is the proportion of patients who remain free of recurrence at 2 years after curative liver resection. Recurrence is defined as radiologically confirmed (via contrast-enhanced CT or MRI according to RECIST 1.1 criteria) appearance of new lesions (intrahepatic or extrahepatic) or death from any cause, whichever occurs first. This outcome will be compared between the intervention arm (AI-guided neoadjuvant therapy + surgery) and the control arm (surgery alone).
Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAEs)
The proportion of patients in the intervention arm who experience at least one Grade 3 or higher adverse event that is judged by the investigator to be related to the neoadjuvant therapy regimen (HAIC + Lenvatinib + PD-1 inhibitor). Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Overall Survival (OS)
The time from the date of randomization (or enrollment for non-randomized studies) to the date of death from any cause. Patients who are still alive at the time of analysis will be censored at the last known date they were alive.
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