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

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04512833
• Lead Sponsor: Beijing 302 Hospital

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 cirrhosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study Start: 2020-08-12
• Study First Posted: 2020-08-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27
• Primary Completion: 2023-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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
• 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 Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local control time	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.
Overall survival time	From date of randomization until the date of death from any cause, assessed up to 36 months	OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
Progression-free survival time	From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months	PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.

Secondary Outcome Measures

Name	Time	Method
Radiation-induced liver injury rates	From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Adverse reaction	From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Trial Locations

Locations (1)

Beijing 302 hospital; 🇨🇳 Beijing, China