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

NCT ID: NCT04966195

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2018-08-30

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy

stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis

Group Type: OTHER

stereotactic body raiotherapy

Intervention Type: RADIATION

stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis

Interventions

stereotactic body raiotherapy

stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

(2016)-050

Identifier Type: -

Identifier Source: org_study_id