Phase II randomized controlled trial of epirubicin hydrochloride and miriplatin hydrate as anticancer agents for transcatheter arterial chemoembolization of hepatocellular carcinoma

Phase II randomized controlled trial of epirubicin hydrochloride and miriplatin hydrate as anticancer agents for transcatheter arterial chemoembolization of hepatocellular carcinoma - NHO-TGMC-2013-02 (HCC-Epirubicin &Miriplatin-P-II)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011785

Enrollment

Registered

2013-09-20

Start date

2013-09-20

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

transcatheter arterial chemoembolization for hepatocellular carcinoma by epirubicin transcatheter arterial chemoembolization for hepatocellular carcinoma by miriplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or clinically diagnosed hepatocellular carcinoma (HCC). 2) No previous history of TACE by epirubicin or miriplatin 3) No previous history of treatment with anticancer agents (neither by systemic nor arterial infusion) 4) No tyreatment effect expected by locoregional treatment. 5) Advanced HCC (BCLC stage-B or C). 6) Child-Pugh A or B. 7) Age of 20 years or more. 8) ECOG Performance Status of 0 or 1 or 2. 9) Existence of mesurable lesion by modified RECIST. 10) No major organ failure and all the laboratory data, below are conserved. 11) At least 3 months survival expected. 12) Written informed consent obtained from the patient.

Exclusion criteria

Exclusion criteria: 1) Drug allergy by miriplatin or epirubicin. 2) Extrahepatic metastasis. 3) Portal venous invasion in the major trunk or first order branch. 4) Remarkable arterio-portal or arterio-venous shunting. 5) Hepatic artery occlusion. 6) Biliary reconstruction. 7) Comorbid diseases *Cardiac failure *Renal failure *Active infection *Active gastrointestinal bleeding *Active associated cancers *Hepatic encephalopathy *Refractory ascites or pleural effusion 8) Fever (more than 38 degrees Celsius) 9) Allergy to contrast media 10) Pregnant or lactating 11) Other reasons not indicated to this study judged by doctors.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
frequency of adverse events, changes of tumor markers, overall survival, one year survival rate, progression free survival	—

Countries

Japan

Contacts

Public ContactMiyuki Toma

Takasaki General Medical Center, National Hospital Organization Clinical Research Department

tcr-jimu3@takasaki-hosp.jp027-322-5901

Outcome results

None listed

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