RecruitingNCT04512833
CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis
CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma
Sponsor
Beijing 302 Hospital
Enrollment
60 participants
Start Date
Aug 12, 2020
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 30 YearsMax Age: 80 Years
Inclusion Criteria10
- 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 Criteria3
- With Tumor thrombus;
- With extrahepatic metastasis;
- With lymph node involvement.
Interventions
RADIATIONCyberknife stereotactic body radiation therapy
A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04512833
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