Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

Korea Cancer Center Hospital

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma; Portal Vein Tumor Thrombus

Treatments: Radiation: Stereotactic ablative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01850368

KROG 13-02 (Registry Identifier)

K-1209-001-007 (Other Identifier)

KCT0000542 (Registry Identifier)

Details and patient eligibility

About

Recently, several studies reported promising outcomes of patients after external beam radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis. However, conventional EBRT is composed of many fractions (20-35 fractions). On the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. SABR increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with major portal vein tumor thrombosis.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients ≥ 20 years of age
• Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
• Eastern Cooperative Oncology Group performance status 0 or 1
• HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
• Cirrhotic status of Child Pugh class A or B7
• 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.
• Patient or guardian must be able to provide verbal and written informed consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Stereotactic ablative radiotherapy

Experimental group

Description:

Stereotactic ablative radiotherapy for HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)

Treatment:

Radiation: Stereotactic ablative radiotherapy