Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE

Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE - Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010291

Enrollment

Registered

2013-04-01

Start date

2013-04-01

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

Multiple hepatocellular carcinoma

Interventions

Miriplatin-TACE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) HCC histologically or clinically confirmed 2) Patients with multiple HCCs that are diagnosed as stageII-IVA and are not indication for surgical resection or local ablation 3) Patients without severe tumor thrombosis in the portal vein, hepatic vein or the bile duct *severe tumor thrombosis (Vp3, Vp4, Vv3) 4) Patients under Child-Pugh A or B 5) Patients under PS 0 or 1 6) Patients who fulfill following A) or B) A) In active clinical trial (C-385, UMIN ID:UMIN000003162), refractory patients to cisplatin or epirubicin-TACE. B) In active clinical trial (C-385, UMIN ID:UMIN000003162), inappropriate patients and patients who fulfill all of the selected criteria below 1.CRE<2.0mg/dl (In active clinical trial, CRE=<1.2mg/dl) 2.WBC>=3000/mm3 3.Plt>=5x10^4/mm3 4.Hb>=8.0g/dl 5.T-Bil=<3.0mg/dl

Exclusion criteria

Exclusion criteria: 1) Patients with another active cancer 2) Patients with extrahepatic metastasis 3) Patients with prior surgical reconstruction of the biliary tract or prior endoscopic treatment of ampulla of vater 4) Patients with clinically significant refractory ascites or pleural effusion 5) Patients with hepatic encephalopathy 6) Patients with severe co-morbidity such as cardiac failure and renal failure 7) Patients with a medical history of severe hypersensitivity 8) Patients who are pregnant, lactating or are suspected to be pregnant. 9) Patients who are concluded to be inappropriate to participate in this study by their physicians

Design outcomes

Primary

Measure	Time frame
Response rate (based on RECICL or mRECIST)	—

Secondary

Measure	Time frame
Progression free survival Disease control rate Safety 1y survival rate	—

Countries

Japan

Contacts

Public ContactYosuke Kasai

Graduate School of Medicine Kyoto University Department of Surgery

shiryou@kuhp.kyoto-u.ac.jp075-751-3608

Outcome results

None listed

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