Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study

Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study - B-TACE study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029504

Enrollment

Registered

2017-10-11

Start date

2017-10-26

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

Balloon occluded transarterial chemoembolization using miriplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1). Histologically or clinically confirmed hepatocellular carcinoma. The largest tumor is<= 5cm. The number of HCC in the patient is within 4 (local recurrent lesion is not allowed). 2). Without major portal invasion (Vp3 or Vp4) 3). Target lesion is not treated. 4). Child-Pugh A or B 5). not the candidate of surgery 6). Adequate organ functions: bone marrow, Heart, renal function (14 days before entry) Neutro =>1,500/mm3 HGB =>8.5g/dl Plt >=5.0x104/mm3 T-Bil <=2.0mg/dl AST <= 5 times ULN ALT <= 5 times ULN PT% > 50% Serum Cre <=1.5 times ULN 7). Over 18 years old 8). ECOG Performance Status 0 or 1 9). Expected survival time over 12 weeks 10). Written informed consent

Exclusion criteria

Exclusion criteria: 1) Bile duct injury(bile duct dilatation), reconstruction of the biliary tract history, history of endoscopic biliary treatment 2) Severe arterio-portal shunting 3) Severe arterial stenosis or obstruction in CECT or AAG 4) Severe ascites or pleural effusion 5) Major portal invation (Vp3 or Vp4) 6) Severe complication (cardiac failure, arrhythmia, angina pectoris, myocardial infarction within 6 months, double cancer, active infection, gastrointestinal bleeding, severe hepatic encephalopathy, severe allergya for contrast media or medicine) 7) Pregnant, nursing or possible pregnant woman 8) Qualified ineligible patients being this clinical trial by responsible doctor

Design outcomes

Primary

Measure	Time frame
Response rate in largest tumor (3 months after treatment)	—

Secondary

Measure	Time frame
Adverse events, progression-free survival, overall survival, response rate of HCC treated by B-TACE (3 months), achievement rate of B-TACE	—

Countries

Japan

Contacts

Public ContactAkira Yamamoto

Osaka Metropolitan Univercity Department of Radiology

loveakirayamamoto@gmail.com06-6645-3831

Outcome results

None listed

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