NCT07014150

Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma

An Exploratory Study on the Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the neoadjuvant therapy of iIparomlimab and Tuvonralimab plus lenvatinib works to treat hepatocellular carcinoma(HCC) patients with high risk of recurrence. It will also learn about the safety of the combination of iIparomlimab and Tuvonralimab plus lenvatinib. The main questions it aims to answer are: Does the combination therapy improve the major pathological response rate and reduce the risk of disease recurrence or progression in HCC patients? What medical problems do participants have when taking this combination regimen? Researchers will compare this combination to previous studies to evaluate its efficacy and safety in managing HCC. Participants will: Take iIparomlimab and Tuvonralimab every 3 weeks for three times and lenvatinib everyday for 9 weeks. Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms and the number of times when taking the combination regimen.

Detailed description

This study is a single-center, single-arm, open-label phase II clinical trial, aiming to evaluate the impact of the neoadjuvant treatment regimen ofIparomlimab and Tuvonralimab plus lenvatinib on postoperative recurrence, survival, and drug safety in patients with hepatocellular carcinoma. Primary objective: Major Pathological response Secondary objectives: Efficacy indicators: Pathological complete response, progression-free survival, overall survival, recurrence-free survival, objective response rate, disease control rate. Safety indicators: Vital signs, laboratory parameters, adverse events (AE), serious adverse events (SAE), drug-related AE and SAE, and specific AE of this type of drug. Exploratory objective: To explore the impact of the combined treatment regimen on the tumor immune microenvironment in tumor tissues and peripheral blood of patients. The target patients are：Patients with hepatocellular carcinoma (HCC) in CNLC stage Ib to IIIa who have at least one of the following high-risk factors for postoperative recurrence: AFP \> 400 ng/ml; a single tumor \> 5 cm; more than 3 tumors or any one of them \> 3 cm; presence of vascular tumor thrombus or tumor adjacent to major vessels, etc. Researchers will recruit 30 patients who will receive: Iparomlimab and Tuvonralimab at 7.5 mg/kg administered intravenously every three weeks (q3w) for three cycles; Lenvatinib orally at 8 mg/day for patients weighing ≤60 kg and 12 mg/day for those \>60 kg, taken daily for 9 weeks. Researchers will evaluate whether the combination therapy improve the major pathological response rate and reduce the risk of disease recurrence or progression in HCC patients.

Conditions

• Hepatocellular Carcinoma Resectable

Interventions

Type	Name	Description
DRUG	Lenvatinib	daily,8mg/ day for less than 60kg, 12mg/ day for more than 60kg, for 9 weeks
DRUG	Iparomlimab and Tuvonralimab	7.5mg/kg, every 3 weeks, for 3cycles.

Timeline

• Start date: 2025-06-10
• Primary completion: 2027-05-01
• Completion: 2027-05-31
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China