Comparison of Efficacy in SBRT of Large HCC With or Without TACE

  • STATUS
    Recruiting
  • End date
    Aug 30, 2026
  • participants needed
    100
  • sponsor
    Beijing 302 Hospital
Updated on 20 September 2021

Summary

The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

Details
Condition Transcatheter Arterial Chemoembolization, Large HCC Patients, transcatheter arterial chemoembolisation, Stereotactic Body Radiation Therapy, SBRT
Clinical Study IdentifierNCT04512846
SponsorBeijing 302 Hospital
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
single lesion and longest tumor diameter were 5-10cm
CP-A or B classification
Eastern Cooperative Oncology Group (ECOG) score 0-1
distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc
rejecting other therapies such as resection, liver transplantation, etc
platelet count50 109/L, white blood count1.5 109/L
patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative

Exclusion Criteria

tumor thrombus
lymph node involvement
extrahepatic metastasis
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