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

B

Beijing 302 Hospital

Status

Enrolling

Conditions

Large HCC Patients
Stereotactic Body Radiation Therapy
Transcatheter Arterial Chemoembolization

Study type

Observational

Funder types

Other

Identifiers

NCT04512846
large HCC with/without TACE

Details and patient eligibility

About

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.

Enrollment

100 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 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 criteria

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

Trial design

100 participants in 2 patient groups

CK-SBRT with TACE group
Description:
The hepatocellular carcinoma patients (5-10cm)who received SBRT with TACE.
CK-SBRT group
Description:
The hepatocellular carcinoma patients (5-10cm)who received SBRT alone.

Trial contacts and locations

1

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Central trial contact

Xuezhang Duan; Jing Sun

Data sourced from clinicaltrials.gov

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