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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
MDN-001 Injection(Yttrium-90 Microsphere Injection)
DrugYttrium-90 Microsphere Injection
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MDN-001 Injection(Yttrium-90 Microsphere Injection)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
12 months2
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.
Time frame
6 months3
Blood biochemistry (including ALT, AST, ALP, Cr and CCr)
Time frame
12 months4
CBC (including WBC, RBC and Hb)
Time frame
12 monthsSecondary outcomes
1
Objective remission rate
(According to mRECIST and RECIST v1. 1 standards)Objective remission rate of liver target lesions assessed by researchers.
Time frame
12 months2
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
Time frame
12 months3
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.
Time frame
12 months4
Progressively free survival
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov