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

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966195
• Other study ID #: (2016)-050
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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