Transcatheter arterial chemoembolization with warmed miriplatin study

JRCT ID: jRCTs031180365

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 27/06/2017
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Miriplatin emulsion warmed at 60 degrees Celsius (maximum dose is 120mg) is injected through the catheter selectively introduced into the hepatic artery. Injection continues till tumor feeding arteries filled by emulsion (maximum dose of miriplatin is 120mg). Additional embolization with gelatin particles is performed for the patients with good liver function, minor vascular infiltration and needed higher curability.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Response rate of each lesion, adverse events, severe adverse events on imaging tests

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1.Hepatocellular carcinoma not appropriate for surgery or local ablation therapy (e.g. radiofrecuency ablation)
2.Hypervascular hepatocellular carcinoma proven by imaging test (CT, MRI, US) regardless of the presence or absence of history of TACE
3.Age greater than or equal to 20, <85
4.Written informed consent

Exclude criteria

1.Liver dysfunction (Child-Pugh C)
2.Total bilirubin greater than or equal to 3mg/dL
3.eGFR < 30mL/min/1.73m2
4.History of allergy or severe complication of TACE
5.History of severe allergy of platinum-containing drugs including miriplatin or iodine agents
6.Severe thyroid disease
7.Pregnant, unwilling to practice contraception during the study, or lactating female
8.Dementia
9.Inappropriate patients for this study judged by the physicians.

Related Information

• Primary Sponsor: Watadani Takeyuki