OncoMatch/Clinical Trials/NCT07391839
MDN-001 Injection for the Treatment of Unresectable Primary Hepatocellular Carcinoma.
Is NCT07391839 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MDN-001 for hepatoma.
Treatment: MDN-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any anti-tumor therapy
The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted therapy, etc.) is less than 4 weeks before the administration of the experimental drug.
Lab requirements
Blood counts
hemoglobin ≥ 80g/L; platelet count > 50×10^9/L; ANC ≥ 1.5×10^9/L; no blood transfusion or G-CSF within 14 days before consent
Kidney function
creatinine ≤1.5x ULN; creatinine clearance rate ≥50 mL/min (Cockcroft-Gault)
Liver function
Child-Pugh score A or better B (≤7); serum total bilirubin (TBIL)≤2x ULN; ALT and AST≤5x ULN; ALP≤2.5x ULN; Albumin > 30 g/L
Cardiac function
LVEF ≥50% by echocardiography
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× 10^9/L; Neutrophil count (ANC) ≥ 1.5× 10^9/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%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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