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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\ 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, the early recurrence rate of high-risk HCC is very high, which seriously affects the overall therapeutic effect.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18-75.

• No previous local or systemic treatment for hepatocellular carcinoma.

• Child-Pugh liver function score ≤ 7.

• ECOG PS 0-1.

• No serious organic diseases of the heart, lungs, brain, kidneys, etc.

• 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.

• Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.

• Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.

Locations
Other Locations
China
Enyu Liu
RECRUITING
Jinan
Huapeng Sun
RECRUITING
Xiangyang
Contact Information
Primary
WanGuang Zhang
wgzhang@tjh.tjmu.edu.cn
13886195965
Backup
xiaoping Chen
chenxpchenxp@163.com
027-83663400
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 160
Treatments
Experimental: Neoadjuvant therapy group
Patients in the neoadjuvant group received neoadjuvant therapy prior to surgery (two cycles of HAIC combined with Tislelizumab and Lenvatinib), and adjuvant therapy (Tislelizumab for 8 cycles) after surgery.
Active_comparator: Direct liver resection group
Patients in the control group underwent liver resection directly and received adjuvant therapy (Tislelizumab for 8 cycles) after surgery.
Related Therapeutic Areas
Sponsors
Leads: Chen Xiaoping

This content was sourced from clinicaltrials.gov