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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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).

MDN-001 Injection for the Treatment of Unresectable Primary Hepatocellular Carcinoma. (NCT07391839) is a Phase 1 interventional studying Hepatoma and Unresectable Hepatocellular Carcinoma (HCC), sponsored by Suzhou Mednovo Yi Medical Technology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Hepatoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Volunteer to join this study and sign the willing to sign a consent form form. - Age: 18\~80 years old (inclusive), regardless of gender. - Clinically diagnosed hepatocellular carcinoma or pathologically diagnosed hepatocellular carcinoma. - You should be able to carry out daily activities with 1 level of ability (ECOG 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. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. * 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. Exclusion Criteria: 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. * 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).

Treatments Being Tested

DRUG

MDN-001 Injection(Yttrium-90 Microsphere Injection)

Yttrium-90 Microsphere Injection

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07391839), the sponsor (Suzhou Mednovo Yi Medical Technology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07391839 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07391839?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07391839?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07391839. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07391839. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.