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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal AI-guided Neoadjuvant Therapy + Surgery | Experimental | Participants identified as high-risk for recurrence by the multimodal deep learning (PRE) model receive neoadjuvant therapy prior to curative liver resection. The neoadjuvant regimen consists of hepatic arterial infusion chemotherapy (HAIC) with the mFOLFOX6 regimen, combined with a PD-1 inhibitor and Lenvatinib. This is followed by standard curative liver resection. |
|
| Surgery Alone (High-Risk) | Active Comparator | Participants identified as high-risk for recurrence by the multimodal deep learning (PRE) model proceed directly to standard curative liver resection without receiving neoadjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant HAIC + Lenvatinib + PD-1 Inhibitor | Combination Product | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wu, M.D. | Contact | +8613636076910 | 255001907@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 438700 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| Curative Liver Resection | Procedure | Standard 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 |
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| Multimodal AI Risk Stratification | Other | The 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. |
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| From the start of neoadjuvant therapy until 30 days after the last dose of neoadjuvant drugs |
| 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. | Up to 3 years post-surgery |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |