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Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma

Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma - Lip-TACE for HCC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020810
Enrollment
20
Registered
2016-01-31
Start date
2005-11-24
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

One TACE for one HCC. administrated dose
d cm= Dx10 mg

Sponsors

Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: unresectable HCC with contraindication of local ablation therapy confirmed histologically or clinically by diagnostic imaging; no extrahepatic metastasis; tumor size less than 10 cm and tumor located in one segmental area or three subsegmental areas; no lingering effects of previous therapy; Eastern Cooperative Oncology Group performance status of 0 to 2; Child-Pugh classification A or B; maintenance of adequate bone marrow, kidney, cardiac function, and meeting clinical laboratory test criteria; age more than 20 years; life expectancy more than 3 months; and provision of written informed consent.

Exclusion criteria

Exclusion criteria: obvious development of feeding artery from an extrahepatic artery (e.g., inferior phrenic artery, inferior adrenal artery, internal mammary artery) to tumor; previous pancreato-biliary surgery or endoscopic sphincteropapillotomy; serious complications other than chronic hepatitis or liver cirrhosis; a history of allergy to iodine-containing agents or contrast media; extrahepatic metastasis; concomitant malignancy; active clinically serious infections; advanced arteriovenous shunt or arterioportal shunt; pregnant or lactating women, or women of childbearing potential; and other serious medical conditions.

Design outcomes

Primary

MeasureTime frame
2-year local disease-free survival rate

Secondary

MeasureTime frame
safety, time to progression and 2-year overall survival rate

Countries

Japan

Contacts

Public ContactHideyuki Nishiofuku

Nara Medical University Radiology

hmn@naramed-u.ac.jp0744-29-8900

Outcome results

None listed

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