A Multimodal Deep Learning-Driven Study for Perioperative Risk Stratification and Precision Intervention in Hepatocellular Carcinoma Recurrence
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 2-year Recurrence-free Survival (RFS) Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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).
- •Severe, uncontrolled medical conditions including but not limited to: Uncontrolled cardiac disease (e.g., NYHA Class III or IV heart failure), Severe renal dysfunction, Uncontrolled hypertension.
- •Inability to Participate: Any condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study or interfere with the evaluation of the study objectives.
结局指标
主要结局
2-year Recurrence-free Survival (RFS) Rate
时间窗: 2 years post-surgery
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).
次要结局
- Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAEs)(From the start of neoadjuvant therapy until 30 days after the last dose of neoadjuvant drugs)
- Overall Survival (OS)(Up to 3 years post-surgery)