Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis

Second Affiliated Hospital, School of Medicine, Zhejiang University100 enrolled

Overview

Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hepatocellular Carcinoma Non-resectable Portal Vein Tumor Thrombosis Stereotactic Body Radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE; 2. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2; 3. no refractory ascites; 4\. Child-Pugh class A and B, or class C with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver Exclusion Criteria: 1. Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.; 2. Diffuse HCC or accompanied by distant metastasis; 3. Severe bleeding tendency or coagulation dysfunction within the previous 6 months; 4. Patients with a history of hepatic encephalopathy

Outcomes

Primary Outcomes

overall survival

The time from the patient received treatment to died from any cause

Time frame: from enrollment to death (for any reason).assessed up to 12 months

Secondary Outcomes

objective response rate

complete or partial response after treatment

Time frame: from enrollment to progression or death (for any reason),assessed up to 12 months