RecruitingNCT04512846

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

Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)


Sponsor

Beijing 302 Hospital

Enrollment

100 participants

Start Date

Aug 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Inclusion Criteria9

  • 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 count≥50 × 109/L, white blood count≥1.5 × 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 Criteria3

  • tumor thrombus;
  • lymph node involvement;
  • extrahepatic metastasis.

Locations(1)

Beijing 302 hospital

Beijing, China

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NCT04512846


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