Neoadjuvant therapy for patients with resectable hepatocellular carcinoma using deep learning.

Efficacy and Safety of Neoadjuvant HAIC Combined With Tislelizumab and Lenvatinib in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial.

This study is testing a new treatment plan using a combination of chemotherapy and other medications for patients with early-stage liver cancer to see if it helps them live longer and reduces the chances of the cancer coming back after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: Lenvatinib
• Locations: 2 sites (Xiangyang, Hubei and 1 other locations)
• Trial ID: NCT06420440 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of neoadjuvant therapy in patients with resectable hepatocellular carcinoma (HCC) identified through a multimodal deep learning model. The approach combines hepatic arterial infusion chemotherapy, lenvatinib, and PD-1 monoclonal antibodies to reduce the risk of postoperative recurrence and improve overall survival. The study utilizes pre-treatment genetic testing, digital pathology, and enhanced MRI data to create an artificial intelligence model that predicts which patients will benefit from this treatment regimen. The trial aims to validate the effectiveness of this model in guiding treatment decisions for high-risk HCC patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resectable HCC at high risk for recurrence, as determined by imaging and genetic data.

Not a fit: Patients with distant metastasis or those who have previously received treatment for HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce recurrence rates and improve survival outcomes for patients with high-risk hepatocellular carcinoma.

How similar studies have performed: While the use of deep learning in oncology is emerging, this specific approach to neoadjuvant therapy in HCC is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-75.
2. No previous local or systemic treatment for hepatocellular carcinoma.
3. Child-Pugh liver function score ≤ 7.
4. ECOG PS 0-1.
5. No serious organic diseases of the heart, lungs, brain, kidneys, etc.
6. Enhanced MRI determines that the tumor is technically resectable but at high risk for recurrence(BCLC-A tumor diameter more than or equal to 5cm; BCLC-B; BCLC-C) ; without distant metastasis.
7. Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.
8. Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.

Exclusion Criteria:

1. Pregnant and lactating women.
2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
4. Active infection.
5. Other significant clinical and laboratory abnormalities that affect the safety evaluation.
6. Inability to follow the study protocol for treatment or follow up as scheduled.

Where this trial is running

Xiangyang, Hubei and 1 other locations

• Huapeng Sun — Xiangyang, Hubei, China (Recruiting)
• Enyu Liu — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: WanGuang Zhang

Conditions HCC; Hepatocellular carcinoma; Neoadjuvant tehrapy; recurrence; Deep learning