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Stereotactic ablative radiotherapy for hepatocellular carcinoma with major portal vein invasion: A phase II study

Stereotactic ablative radiotherapy for hepatocellular carcinoma with major portal vein invasion: A phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0000542
Enrollment
28
Registered
2012-09-24
Start date
2012-10-15
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative

Sponsors

Korea Institute of Radiological & Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female patients =18 years of age 2. Eastern Cooerative Oncology Group performance status 0 or 1 3. HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) 4. Cirrhotic status of Child Pugh class A or B7 5. Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months. 6. Patient or gaurdian must be able to provide verbal and written informed consent

Exclusion criteria

Exclusion criteria: 1. Prior trans-arterial chemo-embolization =4 after diagnosis of major portal vein tumor thrombosis 2. Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy) 3. Uncontrolled inter-current illness except liver cirrhosis

Design outcomes

Primary

MeasureTime frame
Tumor stabilization rate

Secondary

MeasureTime frame
Overall survival;Tumor progression free survival;Treatment related toxicity

Countries

Korea, Republic of

Contacts

Public ContactSun Hyun Bae

Korea Institute of Radiological & Medical Sciences

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026