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

NCT04966195 | Completed

• 1 other identifier: (2016)-050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Hepatocellular carcinoma; Portal vein tumor thrombosis; Stereotactic body radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• objective response rate

  from enrollment to progression or death (for any reason),assessed up to 12 months

Study Arms (1)

radiotherapy

OTHER

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

Radiation: stereotactic body raiotherapy

Interventions

stereotactic body raiotherapy RADIATION

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

radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 19, 2021
• Study Start: December 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: August 30, 2018
• Last Updated: July 19, 2021

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)