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Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE

B

Beijing 302 Hospital

Status

Enrolling

Conditions

Stereotactic Body Radiation Therapy
Small Hepatocellular Carcinoma
Transcatheter Arterial Chemoembolization

Treatments

Procedure: transcatheter arterial chemoembolization

Study type

Observational

Funder types

Other

Identifiers

NCT04161287
JingSun

Details and patient eligibility

About

The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) 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.

Enrollment

330 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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 ≤ 5.0 cm
  • 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 criteria

  • tumor thrombus
  • lymph node involvement
  • extrahepatic metastasis

Trial design

330 participants in 2 patient groups

SBRT with TACE
Treatment:
Procedure: transcatheter arterial chemoembolization
SBRT alone

Trial contacts and locations

1

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Central trial contact

Xuezhang Duan, PH.D; Jing Sun, Master

Data sourced from clinicaltrials.gov

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