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

NCT07391839 | Recruiting Phase 1

• 1 other identifier: MDN-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Hepatoma; Unresectable Hepatocellular Carcinoma (HCC)

Keywords

unresectable hepatocellular carcinoma; HCC; Yttrium-90 Microsphere

Outcome Measures

Primary Outcomes (11)

• 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.

  12 months

• 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.

  6 months

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

  12 months

• CBC (including WBC, RBC and Hb)

  12 months

• Urinalysis (including BLD, BIL and PRO)

  12 months

• Coagulation function (including PT andAPTT)

  12 months

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

  12 months

• Stool examination and OB

  12 months

• 12-lead ECG

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

  12 months

• Vital signs

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

  12 months

• Weight and Height

  Weight in kilograms and height in meters

  12 months

Secondary Outcomes (9)

• Objective remission rate

  12 months

• Time to disease progression

  12 months

• Tumor Response Rate

  12 months

• Progressively free survival

  12 months

• Overall survival

  12 months

Study Arms (1)

MDN-001 Injection(Yttrium-90 Microsphere Injection)

EXPERIMENTAL

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

Interventions

MDN-001 Injection(Yttrium-90 Microsphere Injection) DRUG

Yttrium-90 Microsphere Injection

MDN-001 Injection(Yttrium-90 Microsphere Injection)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Mednovo Yi Medical Technology Co., Ltd.: lead

Study Sites (8)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Henan Cancer Hospital

Henan, Zhengzhou, 450008, China

RECRUITING

Zhongshan hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hongzhang Zhang

CONTACT

+86 13612217714; zhanghongzhang@mednovo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 6, 2026
• Study Start: August 4, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2025-04

Locations

CN (8)