Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial

Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial - Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004317

Enrollment

120

Registered

2010-10-05

Start date

2010-10-01

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

Hepatocellular Carcinoma

Interventions

short term steroid administration Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images 2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy) 3)Performance status (ECOG scale): 0,1 4)Child-Pugh A and B 5)Adequate bone marrow, liver, renal and cardiac function as assessed by the following a)Hemoglobin >= 8.5 g/dl b)Neutrophil >= 1000/mm3 c)Total bilirubin < 3.0mg/dl d)Liver transaminases <= 10 x Upper limit of Normal(ULN) e)PT(INR) <= 2.3 f)ALB >= 2.5 g/dl g)Cre <= 1.5 x ULN

Exclusion criteria

Exclusion criteria: 1)Second primary malignancy 2)Active infection 3)Extrahepatic metastasis 4)Epatoencepharopathy 5)Uncontrolable Pleural effusion and ascitis

Design outcomes

Primary

Measure	Time frame
The proportion of patients with complete response, defined as no fever, no nausea, no vomiting, and no anorexia, during 120 hours after TACE.	—

Countries

Japan

Contacts

Public ContactSadahisa Ogasawara

Chiba University Hospital Department of Gastroenterology

ogasawaras@graduate.chiba-u.jp

Outcome results

None listed

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