Status:

RECRUITING

CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis

Lead Sponsor:

Beijing 302 Hospital

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

30-80 years

Brief Summary

The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cir...

Eligibility Criteria

Inclusion

  • Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
  • Unfeasible or refusing to undergo other treatments;
  • Residual normal liver volume ≥700 cc;
  • With decompensated cirrhosis (Child-Pugh B or C classification);
  • Without portal vein tumor thrombus;
  • Eastern Cooperative Oncology Group (ECOG) score 0-1;
  • Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm;
  • 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

  • With Tumor thrombus;
  • With extrahepatic metastasis;
  • With lymph node involvement.

Key Trial Info

Start Date :

August 12 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 30 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04512833

Start Date

August 12 2020

End Date

August 30 2026

Last Update

June 27 2023

Active Locations (1)

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1

Beijing 302 hospital

Beijing, China, 100039