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HepatomaPhase 1NCT07391839

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

A Phase 1 study testing MDN-001 Injection(Yttrium-90 Microsphere Injection) in people with Hepatoma and Unresectable Hepatocellular Carcinoma (HCC), run by Suzhou Mednovo Yi Medical Technology Co., Ltd. at 8 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
MDN-001 Injection(Yttrium-90 Microsphere Injection)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
8 sitesChina
Study dates
4 Aug 2025to 31 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to join this study and sign the informed consent form.
  • Age: 18~80 years old (inclusive), regardless of gender.
  • Clinically diagnosed hepatocellular carcinoma or pathologically diagnosed hepatocellular carcinoma.
  • ECOG performance status of 1 or less
  • Child-Pugh score A or better B (≤7).
  • Patients who are assessed by researchers as currently unacceptable for surgical resection or ablation, or who refuse to undergo surgical resection or ablation.
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  • According to mRECIST standard, in contrast-enhanced MRI or CT images, there must be at least one measurable liver target lesion with the longest diameter ≥1 cm. If there are multiple target lesions, the researcher will choose them.
  • According to the researcher's evaluation, the expected survival time is ≥3 months.
  • There is no extrahepatic metastasis, and there are no other malignant tumors besides liver cancer.
  • The main organs function normally and meet the following requirements: blood routine: no blood transfusion or colony stimulating factor (G-CSF) treatment within 14 days before signing the informed consent form, and hemoglobin ≥ 80g/L; Platelet count > 50× 109/L; Neutrophil count (ANC) ≥ 1.5× 109/L. Liver function: serum total bilirubin (TBIL)≤2 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤5.0 times ULN；; Alkaline phosphatase (ALP)≤2.5 times ULN；; Albumin > 30 g/L. Renal function: creatinine (Cr)≤1.5 times ULN；; Creatinine clearance rate ≥50 mL/min (calculated according to Cockcroft-Gault formula). Coagulation function: INR, PT and APTT)≤1.5 times ULN. If the subjects take warfarin or heparin for anticoagulant therapy, it is necessary to ensure that they meet the requirements of the protocol when they stop taking the drug or not. Cardiovascular function: echocardiography: LVEF (left ventricular ejection fraction) ≥50%.
  • According to the standard of CTCAE5.0, all the adverse events of previous systemic anti-tumor therapy were restored to baseline or ≤1 grade [except: the neuropathy induced by previous anti-tumor therapy was stable (≤2 grade); Hair loss, fatigue, etc., which are judged by the researchers based on the actual clinical situation, cannot be restored to ≤1 level and will be in a stable state for a long time; Stable hypothyroidism after hormone replacement therapy].
  • Women and men of childbearing age must agree to take strict and effective contraceptive measures after signing informed consent, during the study period and within 6 months after the end of the experiment; Men are forbidden to donate sperm during this period, and the pregnancy test results of female subjects of childbearing age during the screening period and within 24 hours before administration must be negative.

Who cannot join

  • Participants who meet any of the following criteria are not allowed to participate in this study:
  • Severe liver dysfunction: including severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome.
  • Patients who are suitable for surgical resection or ablation after evaluation by researchers: 1) patients who are suitable for surgical resection include but are not limited to the following situations: a) patients with good liver reserve function in CNLC Ia~IIa stage; B) If the tumor is confined to the same hepatic segment or ipsilateral hemihepatis, after MDT discussion, the patients with CNLC IIb stage who may get better effect by surgical resection than other treatments; 2) Suitable for ablation treatment includes but is not limited to the following situations: A)CNLC Ia patients; B) patients with CNLC Ib stage and Child-Pugh score of liver function grade A or better grade B (≤7).
  • The liver area has received external radiotherapy before.
  • Severe pulmonary insufficiency (FEV1/FVC\&1t; 50% or FEV1\&1t: 50% expected value or maximum ventilation per minute < 50 L/min), patients with obvious chronic obstructive pulmonary disease or interstitial pneumonia.
  • Arterial perfusion imaging of technetium [99mTc] polymerized albumin (99mTc-MAA) showed that the percentage of hepatopulmonary shunt was more than 20%, or the absorbed dose of single lung radiation was more than 30 Gy, or the accumulated absorbed dose of lung radiation was more than 50 Gy.
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  • Hepatic arteriography and 99mTc-MAA hepatic artery perfusion imaging showed gastrointestinal shunts, which may not be corrected by vascular interventional techniques.
  • Can't intubate hepatic artery, such as vascular malformation, allergic to contrast agent, allergic to anesthetic, etc.
  • There is a tumor thrombus in the main portal vein.
  • The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted therapy, etc.) is less than 4 weeks before the administration of the experimental drug.
  • Participation in other clinical studies within 4 weeks before the first administration of the study drug.
  • It is expected that any other forms of anti-tumor therapy will be needed during the study.
  • Those who have been vaccinated with live attenuated vaccine within 28 days before the administration of the first study drug or plan to be vaccinated within 60 days after the treatment of the study drug.
  • People with previous history of epilepsy.
  • Patients who have undergone major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first use of the study drug, or need to undergo elective surgery during the trial.
  • Patients who have undergone bone marrow transplantation or solid organ transplantation in the past.
  • Untreated or being treated tuberculosis patients, including but not limited to tuberculosis; Those who have been treated with standardized anti-tuberculosis treatment and confirmed to have been cured by researchers can be included.
  • Patients with active infection of grade ≥2 who need systemic treatment of antibiotics within 2 weeks before the administration of the study drug.
  • Patients who have been diagnosed with immunodeficiency disease and/or who have tested positive for human immunodeficiency virus (HIV) at the time of screening.
  • Patients with clinically significant cardiovascular and cerebrovascular diseases within 6 months before the first administration of the study drug, including but not limited to: acute myocardial infarction; Severe/unstable angina pectoris; History of arterial thromboembolism, including but not limited to cerebrovascular accidents; Congestive heart failure [new york Heart Association (NYHA) > Grade II; Any clinically significant resting ECG rhythm, abnormal conduction or morphology, complete left bundle branch block, degree III cardiac block, degree II cardiac block, and PR interval > 250 ms；; The average corrected QT interval (QTCF) obtained by three ECG examinations is > 450 msec (C male) or > 470 msec (female) (only when the first ECG prompts QTCF to be > 450 msec (male) or > 470 msec (female), it is necessary to retest and take the average corrected value for three times (corrected according to Fridericia formula); Hypertension beyond the control of antihypertensive drugs (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg). Other cardiovascular and cerebrovascular diseases that researchers think are not suitable for selection.
  • Have a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid treatment, or any evidence of clinically active ILD.
  • Patients with mental illness that is known to interfere with trial compliance or still need drug control.
  • Pregnant or lactating female patients.
  • Any patient with severe, acute or chronic medical or mental illness or laboratory abnormality who may increase the risk of participating in the study or using the study drugs or may interfere with the interpretation of the study results and who the researcher thinks will not be suitable for participating in the study.
  • According to the investigator's judgment, any other circumstances that prevent the patient from participating in the clinical trial (for safety reasons) or hinder the compliance of the clinical trial procedure (for example, difficulty in venous blood collection).

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hongzhang Zhang contact

+86 13612217714

zhanghongzhang@mednovo.com.cn

8 sites in 1 country

China8 sites, 8 recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Recruiting

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Recruiting

  • Henan Cancer Hospital

    Henan, Zhengzhou, 450008

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • Zhongda Hospital

    Nanjing, Jiangsu, 210009

    Recruiting

  • Zhongshan hospital

    Shanghai, 200032

    Recruiting

Other trials in China

About this study

Official title: 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).

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.

Read the 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.

Being tested
MDN-001 Injection(Yttrium-90 Microsphere Injection)
Keywords
unresectable hepatocellular carcinoma, HCC, Yttrium-90 Microsphere
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDN-001 Injection(Yttrium-90 Microsphere Injection)Drug

    Yttrium-90 Microsphere Injection

Study groups in NCT07391839
Study groupRoleWhat they receive
MDN-001 Injection(Yttrium-90 Microsphere Injection)ExperimentalNot described
Receives: Drug: MDN-001 Injection(Yttrium-90 Microsphere Injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs)

    Record the types, frequencies and severity of AEs, SAEs, TEAEs and TRAEs, and grade them according to CTCAE v5.0.

    Measured: 12 months

  2. Objective remission rate（IRC）

    The objective remission rate of liver target lesions evaluated by independent review committee (IRC) 6 months after administration of MDN-001 injection.

    Measured: 6 months

  3. Blood biochemistry (including ALT, AST, ALP, Cr and CCr)

    Measured: 12 months

  4. CBC (including WBC, RBC and Hb)

    Measured: 12 months

  5. Urinalysis (including BLD, BIL and PRO)

    Measured: 12 months

  6. Coagulation function (including PT andAPTT)

    Measured: 12 months

  7. Cardiac enzyme panel (including CK, CK-MB and cTn)

    Measured: 12 months

  8. Stool examination and OB

    Measured: 12 months

  9. 12-lead ECG

    OT interval (milliseconds), Rate (times per minute)

    Measured: 12 months

  10. Vital signs

    Body temperature (℃), Pulse/Heart rate (beats per minute, bpm)

    Measured: 12 months

  11. Weight and Height

    Weight in kilograms and height in meters

    Measured: 12 months

Secondary outcomes (9)

  1. Objective remission rate

    (According to mRECIST and RECIST v1. 1 standards)Objective remission rate of liver target lesions assessed by researchers.

    Measured: 12 months

  2. Time to disease progression

    (According to mRECIST and RECIST v1. 1 standards)The time from liver target lesion to disease progression evaluated by researchers and IRC

    Measured: 12 months

  3. Tumor Response Rate

    (According to mRECIST and RECIST v1. 1 standards)The duration of remission (DOR), disease control rate (DCR) and complete remission rate (CRR) are evaluated by the researchers and IRC.

    Measured: 12 months

  4. Progressively free survival

    Measured: 12 months

  5. Overall survival

    Measured: 12 months

  6. Changes of tumor marker alpha-fetoprotein before and after administration

    Measured: 12 months

  7. Actual distribution of yttrium-90

    Actual distribution of yttrium -90 in human body within 24 hours after administration.

    Measured: 24 hours

  8. Radioactivity of Yttrium-90 in blood, urine and feces of Participants

    Radioactivity of Yttrium -90 in blood, urine and feces of subjects after administration.

    Measured: 14 days

  9. Absorbed dose and effective dose of internal irradiation after administration

    Absorbed dose and effective dose of internal irradiation after administration: The tumor/normal liver uptake ratio (T/N ratio) and liver shunt fraction (LSF) were calculated according to SPECT/CT or PET/CT data.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start4 Aug 2025
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07391839
Sponsor's protocol ID
MDN-001
Status last verified
Apr 2025
First submitted
17 Dec 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDN-001 Injection(Yttrium-90 Microsphere Injection) in people with Hepatoma and Unresectable Hepatocellular Carcinoma (HCC), run by Suzhou Mednovo Yi Medical Technology Co., Ltd. at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongzhang Zhang (+86 13612217714, zhanghongzhang@mednovo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) (time frame: 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07391839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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