Transarterial infusion chemotherapy using SMANCS with or without embolization in hepatocellular carcinoma: a randomised controlled multicenter phase III trial

Transarterial infusion chemotherapy using SMANCS with or without embolization in hepatocellular carcinoma: a randomised controlled multicenter phase III trial - Transarterial infusion chemotherapy with or without embolization in hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000111

Enrollment

160

Registered

2005-09-04

Start date

1999-10-01

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

transcatheter arterial chemoembolization Transarterial infusion chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with unresectable hepatocellular carcinoma are eligible if they had no indication for resection or local ablation therapy. Diagnosis is confirmed histologically and/or clinically by angiography and computed tomography. Each patient is required to meet the following criteria: no prior therapy for hepatocellular carcinoma, tumor volume less than 50% of the entire liver, Nodular type in Eggel's classification, adequate hematological function (white blood cells >= 3000/mm3, platelets >= 50000/mm3, hemoglobin >= 9.0 g/dl), adequate hepatic function (serum total bilirubin == 3.0 g/dl, serum AST =< five times the upper limit of normal value, serum ALT =< five times the upper limit of normal value), adequate renal function (BUN =< the upper limit of normal value, serum creatinine =< the upper limit of normal value), ECOG performance status of 0-1, at least one measurable intrahepatic lesion that showed tumor staining by angiography, and written informed consent.

Exclusion criteria

Exclusion criteria: Patients were excluded if they met the following criteria: extrahepatic metastasis or tumor thrombus in the portal vein and/or the hepatic vein, refractory pleural or peritoneal effusion, a history of allergy to iodine-containing agent and/or contrast material, a history of acute myocardial infarction in preceding 3 months, serious mental disorder, concomitant malignancy, pregnant or lactating women and patients of reproductive potential, intrahepatic arteriovenous shunting, or other serious medical conditions.

Design outcomes

Primary

Measure	Time frame
survival	—

Countries

Japan

Contacts

Public ContactTakuji Okusaka

National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division

03-3542-2511

Outcome results

None listed

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