Phase I/II trial of cisplatin-based transarterial infusion and concomitant radiotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis

Phase I/II trial of cisplatin-based transarterial infusion and concomitant radiotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis - Transarterial infusion and concomitant radiotherapy for hepatocellular carcinoma with portal vein tumor thrombosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006822

Enrollment

Registered

2012-02-01

Start date

2012-02-01

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 with portal vein tumor thrombosis

Interventions

Radiotherapy for portal vein tumor thrombus will be administered in fractions of 2.0 Gy/day, given 5 days per week for 25 days. The total dose of radiation will be 50 Gy. Transarterial infusion of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologicaly or clinically confirmed as HCC HCC with PVTT in main trunk or first brunch (Vp3, 4) Child-Pugh score is less than 8. Liver damage classification is A or B ECOG performance status is 0 - 2. Patients do not receive any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment Patients do not receive partial splenic embolization within 4 weeks prior to the initiation of study treatment No disturbance of main organ functions ( including bone marrow, heart, lung, liver and kidney) Leukocyte count: >=3,000/mm3 Platelet count: >=75,000/mm3 Hemoglobin concentration: >=8.0 g/dl Serum AST and ALT: less than five times the upper limit of the normal at our hospital. Total bilirubin concentration: <=3.0 mg/dl Protrombin time: >=50 % Serum creatinine concentration: <=1.2 mg/dl Creatinine crearance:>= 45 ml/min

Exclusion criteria

Exclusion criteria: Patients who have received platinum based anti cancer drug prior to the initiation of study treatment extrahepatic metastasis HCC with severe hepatic vein and biliary tumor thrombosis Untreated esophageal and gastric varices with red color signs stage II-IV encephalopathy Allergic to a contrast media and platinum Severe complications such as interstitial pneumonia, DM, heart failure, lung failure and liver failure Active infection Other cancers

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in Phase 1 PVTT response rate in Phase 2	—

Secondary

Measure	Time frame
Adverse Event/Serious Adverse Event Hepatic tumor response rate (overall tumor response rate) Progression-free survival (PFS) Overall survival (OS) Change from baseline in hepatic functional reserve	—

Countries

Japan

Contacts

Public ContactTakuya Okada

Kobe University Hospital Department of Radiology

078-382-6104

Outcome results

None listed

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