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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: WanGuang Zhang
• Email: wgzhang@tjh.tjmu.edu.cn
• Phone: 13886195965

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• QL1706 (iparomlimab + tuvonralimab) with TACE and lenvatinib for second-line treatment of unresectable intermediate-to-advanced liver cancer

  This test will try whether adding QL1706 (iparomlimab plus tuvonralimab) to TACE and lenvatinib helps people with unresectable intermediate-to-advanced hepatocellular carcinoma who progressed after PD-1/PD-L1 plus bevacizumab.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07099274

• Combining sintilimab, lenvatinib, and HAIC for treating borderline resectable liver cancer before surgery

  This study is testing if a combination of three treatments can help people with borderline resectable liver cancer do better in surgery compared to having surgery right away.

  Recruiting Phase 2 Shandong Cancer Hospital and Institute · Jinan, Shandong · NCT06904014

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• MRG003 added to ongoing treatment after progression in EGFR-positive advanced thyroid cancer

  In this study, researchers test whether adding MRG003 to a patient’s current thyroid cancer treatment can shrink tumors for those whose cancer initially responded but later progressed.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07874321

• Cryoablation with liver-directed immunotherapy and targeted therapy for melanoma liver metastases

  This trial tests a combination therapy including cryoablation, hepatic artery delivery of QL1706, intravenous dacarbazine, and oral lenvatinib to treat liver metastases from malignant melanoma in adults.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07847359

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.