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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966195
Other study ID # (2016)-050
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2015
Est. completion date August 30, 2018

Study information

Verified date June 2017
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 30, 2018
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China the second affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival The time from the patient received treatment to died from any cause from enrollment to death (for any reason).assessed up to 12 months
Secondary objective response rate complete or partial response after treatment from enrollment to progression or death (for any reason),assessed up to 12 months
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