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

Last updated: June 24, 2023
Sponsor: Beijing 302 Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Cancer/tumors

Carcinoma

Treatment

Cyberknife stereotactic body radiation therapy

Clinical Study ID

NCT04512833
decompensated cirrhosis HCC
  • Ages 30-80
  • All Genders

Study 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 cirrhosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to theinternational 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) aremore 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

Exclusion Criteria:

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

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Cyberknife stereotactic body radiation therapy
Phase:
Study Start date:
August 12, 2020
Estimated Completion Date:
August 30, 2026

Connect with a study center

  • Beijing 302 hospital

    Beijing, 100039
    China

    Active - Recruiting

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