Phase I clinical trial of preoperative arterial immuno-embolization with OK-432 / fibrinogen / lipiodol for resectable primary hepatocellular carcinoma

Phase I clinical trial of preoperative arterial immuno-embolization with OK-432 / fibrinogen / lipiodol for resectable primary hepatocellular carcinoma - Phase I clinical trial of preoperative immuno-embolization for resectable primary hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017902

Enrollment

Registered

2015-06-15

Start date

2013-06-20

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

Primary hepatocellular carcinoma

Interventions

TIE with embolic material containing OK-432 (2.5KE/ml), fibrinogen (60mg/ml) with lipiodol (0.5ml). Injection volume is determined depending on the tumor size (2.5-10ml). Hepatectomy will be performed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with primary hepatocellular carcinoma. 2. Patients who have resectable hepatocellular carcinoma without any previous treatment. 3. age 20-75 years old 4. ECOG performance status 0-2 5.Meets the following criteria within 14 days before enrollment. white blood count: >3,500/mm3 absolute neutrophill: >2,000/mm3 hemoglobin: >9 g/dL platelet count: >80,000/mm3 total bilirubin: < 2.0mg/dL AST and ALT: <100 U/L Creatinine =< 1.2 mg/dL CCr: =< 60mL/min 6.Patients who can take oral ingestion. 7.Patients who have no abnormal electrocardiogram within 28 days before enrollment. 8.Patients who provide a personally signed and dated informed consent document.

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet inclusion criteria. 2. Patients whohave a history of shock against OK-432, fibrinogen or r active peptic ulcer etc) 3. with active infection. 4. Serious complications (organ failure, o or pleural effusion. 5. confirm the presence of moderate ascitesbenzylpenicillin. 6. Active double cancer 7. Patients who can not discontinue anticoagulant drugs. 8.Pregnancy 9.Severe mental disorder, or central nervous system disorders 10.Serious drug allergy 11.Patients having trauma unhealed 12.Patients with allergic to iodine-based contrast agent 13.Inappropriate for this study judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Systemic immune response Histological immune responses with resected specimen	—

Countries

Japan

Contacts

Public ContactAkira Kenjo

Fukushima Medical University Department of Hepato-Biliary-Pancreatic and Transplant Surgery

a-kenjo@fmu.ac.jp024-547-1254

Outcome results

None listed

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