Actively Recruiting
MDN-001 Injection for the Treatment of Unresectable Primary Hepatocellular Carcinoma.
Led by Suzhou Mednovo Yi Medical Technology Co., Ltd. · Updated on 2026-02-06
40
Participants Needed
8
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MDN-001 Injection for the Treatment of Unresectable Primary Hepatocellular Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to join this study and sign the informed consent form.
- Age between 18 and 80 years old, any gender.
- Clinically or pathologically diagnosed hepatocellular carcinoma.
- ECOG performance status of 1 or less.
- Child-Pugh score A or better B (≤7).
- Assessed as unsuitable for surgical resection or ablation, or refusal of these treatments.
- At least one measurable liver lesion ≥1 cm on contrast-enhanced MRI or CT by mRECIST.
- Expected survival time of 3 months or more.
- No extrahepatic metastasis and no other malignant tumors besides liver cancer.
- Normal main organ function meeting specific laboratory criteria for blood, liver, renal, coagulation, and cardiovascular function.
- Adverse events from previous anti-tumor therapy resolved to baseline or grade 1, with specified exceptions.
- Women and men of childbearing age agree to strict contraception during and for 6 months after the study; males prohibited from donating sperm during this time; negative pregnancy test for females during screening and within 24 hours before treatment.
You will not qualify if you...
- Severe liver dysfunction such as severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
- Suitable for surgical resection or ablation after evaluation.
- Prior external radiotherapy to the liver area.
- Severe pulmonary insufficiency or significant lung diseases.
- Hepatopulmonary shunt >20% or lung radiation dose limits exceeded.
- Gastrointestinal shunts not correctable by vascular intervention.
- Inability to intubate hepatic artery due to vascular malformation or allergies.
- Tumor thrombus in the main portal vein.
- Anti-tumor treatment within 4 weeks before study drug administration.
- Participation in other clinical studies within 4 weeks before first dose.
- Need for other anti-tumor therapies during the study.
- Recent live attenuated vaccination or planned vaccination within specified periods.
- History of epilepsy.
- Major organ surgery or significant trauma within 4 weeks before first dose.
- Past bone marrow or solid organ transplantation.
- Untreated or active tuberculosis.
- Active infection requiring systemic antibiotics within 2 weeks before treatment.
- Immunodeficiency or HIV positive at screening.
- Significant cardiovascular or cerebrovascular disease within 6 months before treatment.
- History of interstitial lung disease or related conditions.
- Mental illness interfering with trial compliance.
- Pregnant or breastfeeding women.
- Severe medical or mental illness or lab abnormalities increasing risk or interfering with study.
- Other conditions judged by investigators as preventing participation or compliance.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
2
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
3
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
4
Zhongda Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
5
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
7
Henan Cancer Hospital
Henan, Zhengzhou, China, 450008
Actively Recruiting
8
Zhongshan hospital
Shanghai, China, 200032
Actively Recruiting
Research Team
H
Hongzhang Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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