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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma Non-resectable; Portal Vein Tumor Thrombosis; Stereotactic Body Radiotherapy
• Interventions: Radiation: stereotactic body raiotherapy

• Registration Number: NCT04966195
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Status Verified: 2017-06
• Primary Completion: 2017-06-30
• Study Completion: 2018-08-30
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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;

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiotherapy	stereotactic body raiotherapy	stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis

Primary Outcome Measures

Name	Time	Method
overall survival	from enrollment to death (for any reason).assessed up to 12 months	The time from the patient received treatment to died from any cause

Secondary Outcome Measures

Name	Time	Method
objective response rate	from enrollment to progression or death (for any reason),assessed up to 12 months	complete or partial response after treatment

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China