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Transcatheter arterial chemoembolization with warmed miriplatin study

Efficacy and safety of transcatheter arterial chemoembolization with warmed miriplatin for unresectable hepatocellular carcinoma - Miriplatin TACE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180365
Enrollment
30
Registered
2019-03-18
Start date
2017-06-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

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 arterie

Sponsors

Watadani Takeyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Response rate of each lesion, adverse events, severe adverse events on imaging tests

Contacts

Public ContactTakeyuki Watadani

The University of Tokyo Hospital

watadat-tky@umin.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026