MDN-001 Injection for the Treatment of Unresectable Primary Hepatocellular Carcinoma.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Mednovo Yi Medical Technology Co., Ltd.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MDN-001 Injection(Yttrium-90 Microsphere Injection)
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov