Skip to main content
OpenTrials
Completed

NCT Number: NCT04966195

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Non-resectable Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Portal Vein Tumor Thrombosis Stereotactic Body Radiotherapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

Treatment and study plan

stereotactic body raiotherapy

Radiation

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

Primary outcomes

  1. overall survival

    Time frame: 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 outcomes

  1. objective response rate

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

    complete or partial response after treatment

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2021
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.