NCT07391839

MDN-001 Injection for the Treatment of Unresectable Primary Hepatocellular Carcinoma.

A Multicenter, Open-label, Single-Arm Phase I/II Clinical Study to Evaluate the Safety and Efficacy of a Single Dose of MDN-001 Injection in Patients With Unresectable Primary Hepatocellular Carcinoma (HCC).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Suzhou Mednovo Yi Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to evaluate the safety and efficacy of MDN-001 injection(Yttrium-90 Microsphere Injection)in the treatment of unresectable hepatocellular carcinoma. Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.

Detailed description

A multicenter, open and single-arm phase I clinical study to evaluate the safety and efficacy of MDN-001 injection(Yttrium-90 Microsphere Injection) in the treatment of unresectable hepatocellular carcinoma. The study aims to recruit 40 patients over a period of 24 months.

Conditions

• Hepatoma
• Unresectable Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	MDN-001 Injection(Yttrium-90 Microsphere Injection)	Yttrium-90 Microsphere Injection

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-08-30
• Completion: 2027-05-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

8 sites across 1 country: China