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

Hepatocellular Carcinoma Clinical Trial

Official title:

CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04512833
• Other study ID #: decompensated cirrhosis HCC
• Status: Recruiting
• Start date: August 12, 2020
• Est. completion date: August 30, 2026

Study information

• Verified date: March 2023
• Source: Beijing 302 Hospital
• Contact: Jing Sun
• Phone: +8613718681094
• Email: 519299998[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Cyberknife 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

Country	Name	City	State
China	Beijing 302 hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin — View Citation

Culleton S, Jiang H, Haddad CR, Kim J, Brierley J, Brade A, Ringash J, Dawson LA. Outcomes following definitive stereotactic body radiotherapy for patients with Child-Pugh B or C hepatocellular carcinoma. Radiother Oncol. 2014 Jun;111(3):412-7. doi: 10.10 — View Citation

Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and Child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017 Feb;18(2):e101-e112. doi: 10.1016/S1470-2045(16)30569-1. — View Citation

Huertas A, Baumann AS, Saunier-Kubs F, Salleron J, Oldrini G, Croise-Laurent V, Barraud H, Ayav A, Bronowicki JP, Peiffert D. Stereotactic body radiation therapy as an ablative treatment for inoperable hepatocellular carcinoma. Radiother Oncol. 2015 May;1 — View Citation

Sun J, Zhang A, Li W, Wang Q, Wang J, Fan Y, Sun Y, Li D, Zhang D, Duan X. CyberKnife Stereotactic Body Radiation Therapy as an Effective Treatment for Hepatocellular Carcinoma Patients With Decompensated Cirrhosis. Front Oncol. 2020 Feb 25;10:100. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time	OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.	From date of randomization until the date of death from any cause, assessed up to 36 months
Primary	Progression-free survival time	PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.	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
Primary	Local control time	LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.	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
Secondary	Radiation-induced liver injury rates		From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Secondary	Adverse reaction		From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.