RecruitingPhase 1NCT07391839

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).


Sponsor

Suzhou Mednovo Yi Medical Technology Co., Ltd.

Enrollment

40 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new injected drug called MDN-001 for people with primary liver cancer (hepatocellular carcinoma) that cannot be surgically removed or ablated. This is an early-phase study examining how safe the drug is and whether it shows signs of shrinking tumors. **You may be eligible if...** - You are 18 to 80 years old - You have been clinically or pathologically diagnosed with primary liver cancer (hepatocellular carcinoma) - Your liver function is reasonably preserved (Child-Pugh A or mild B) - Your cancer cannot be removed by surgery or ablation, or you prefer not to have those procedures - You have at least one measurable liver tumor that is at least 1cm - Your general health is good (ECOG score 0–1) and expected survival is at least 3 months **You may NOT be eligible if...** - You have already received certain prior cancer treatments that conflict with this trial - Your liver function is severely impaired - You have serious heart, kidney, or blood problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMDN-001 Injection(Yttrium-90 Microsphere Injection)

Yttrium-90 Microsphere Injection


Locations(8)

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Zhongda Hospital

Nanjing, Jiangsu, China

Shandong Cancer Hospital

Jinan, Shandong, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Henan Cancer Hospital

Henan, Zhengzhou, China

Zhongshan hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07391839


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