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A prospective randomized controlled trial of preoperative transarterial chemoembolization of the selective, whole liver or no preoperative transarterial chemoembolization for hepatocellular carcinoma

A prospective randomized controlled trial of preoperative transarterial chemoembolization of the selective, whole liver or no preoperative transarterial chemoembolization for hepatocellular carcinoma - Preoperative TACE vs. no preoperative TACE for HCC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004963
Enrollment
120
Registered
2011-01-26
Start date
2004-01-01
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

A primary hepatocellular carcinoma case

Interventions

Preoperative transarterial chemoembolization of whole liver for hepatocellular carcinoma Preoperative transarterial chemoembolization of the selective liver for hepatocelullar carcinoma No preoperativ

Sponsors

Departement of Surgery, Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)no preceded treatment 2)no extrahepatic lesion or major vascular invasion 3)performance status 0-2 4) bone marrow function and hepatic/renal functions are well maintained a)White blood cell count: 2000- 10000/mm3 b)Platelet count of 50000/mm3 or more c)Hemoglobin of 8.0g/dL or more d)Serum total bilirubin of 2.0mg/dL or less e)Prothronbin time of 50% or more f)Serum creatinine of 1.5mg/dL or less g)Blood urea nitrogen of 35mg/dL or less

Exclusion criteria

Exclusion criteria: 1) Double cancer or history of other malignancy within 5 years after diagnosis 2) History of myocardial infarction or unstable angina within 6 months prior to registration 3) Patient with interstitial pneumonia, pneumofibrosis, or severe lung emphysema 4) Patient who cannot undergo enhanced CT scan due to some reason such as allergy for iodized contrast media or renal dysfunction 5) Patient with psychiatric disorder or symptom 6) Pregnant patient or patient with possibility to be pregnant

Design outcomes

Primary

MeasureTime frame
Overall survival Recurrence-free survival

Secondary

MeasureTime frame
Preoperative liver function Types of recurrence Therapeutic choice for primary recurrence

Countries

Japan

Contacts

Public ContactMasaki Kaibori

Kansai Medical University Surgery

kaibori@hirakatra.kmu.ac.jp072-804-0101

Outcome results

None listed

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