Back to resultsStereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
Primary Purpose
Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombosis, Stereotactic Body Radiotherapy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stereotactic body raiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Hepatocellular carcinoma, Portal vein tumor thrombosis, Stereotactic body radiotherapy
Eligibility Criteria
Inclusion Criteria:
- tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
- 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:
- Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
- Diffuse HCC or accompanied by distant metastasis;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Patients with a history of hepatic encephalopathy
Sites / Locations
- the second affiliated hospital of Zhejiang University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
radiotherapy
Arm Description
stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Outcomes
Primary Outcome Measures
overall survival
The time from the patient received treatment to died from any cause
Secondary Outcome Measures
objective response rate
complete or partial response after treatment
Full Information
NCT ID
NCT04966195
First Posted
July 11, 2021
Last Updated
July 11, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04966195
Brief Title
Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
Official Title
Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombosis, Stereotactic Body Radiotherapy
Keywords
Hepatocellular carcinoma, Portal vein tumor thrombosis, Stereotactic body radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiotherapy
Arm Type
Other
Arm Description
stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Intervention Type
Radiation
Intervention Name(s)
stereotactic body raiotherapy
Intervention Description
stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Primary Outcome Measure Information:
Title
overall survival
Description
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 Outcome Measure Information:
Title
objective response rate
Description
complete or partial response after treatment
Time Frame
from enrollment to progression or death (for any reason),assessed up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
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:
Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
Diffuse HCC or accompanied by distant metastasis;
Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
Patients with a history of hepatic encephalopathy
Facility Information:
Facility Name
the second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
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