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A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas

A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas - A romdomized controlled study of effectiveness between CDDP-TACE and EPI-TACE for multiple HCCs

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003162
Enrollment
160
Registered
2010-04-01
Start date
2010-04-01
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 hepatocellar carcinomas

Interventions

Epirubicin-TACE Cisplatin-TACE

Sponsors

Department of Surgery, Graduate School of Medicine Kyoto Uinversity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with HCC that are histologically or clinically confirmed 2)Patients with multiple HCCs that are diagnosed as stage2-4a and cannot be selected for surgical resection or local ablation 3)Patients without severe tumor thrombosis in the portal vein, hepatic vein and the bile duct 4)Patients under Child-Pugh A or B 5)Patients under PS 0 or 1 6)Patients who fulfill all of the selected criteria below 1.WBC>=3000/mm3 2.Plt>=5x10^4/mm3 3.Hb>=8.0g/dl 4.T-Bil=<3.0mg/dl 5.ALB=<2.8g/dl 6.CRE=<1.2mg/dl 7)Patients who are 20 years and older and who are autonomous independent adults

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 who have taken doses of chemotherapeutic agents with cardiac toxicity exceeding a set threshold. 8)Patients with a medical history of severe hypersensitivity 9)Patients who are pregnant, lactating or are suspected to be pregnant. 10)Patients who are concluded to be inappropriate to participate in this study by their physicians

Design outcomes

Primary

MeasureTime frame
Response rate(based on EASL criteria)

Secondary

MeasureTime frame
Overall survival Progression free survival Response rate(based on the General Rules for the Clinical and Pathological Study of Primary Liver Cancer) Safety

Countries

Japan

Contacts

Public ContactHatano Etsuro

Graduate School of Medicine Kyoto Uinversity Department of Surgery

etsu@kuhp.kyoto-u.ac.jp075-751-4323

Outcome results

None listed

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