Clinical trial NCT04512833: CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis
Official title: CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
CyberKnife
stereotactic body radiation therapy
Child-Pugh B classification
Child-Pugh C classification
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival time
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: Progression-free survival time
timeFrame: 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
measure: Local control time
timeFrame: 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 outcomes:
measure: Radiation-induced liver injury rates
timeFrame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
measure: Adverse reaction
timeFrame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 hospital
Study officials:
References:
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: 10.3389/fonc.2020.00100. eCollection 2020.
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: 10.1016/j.radonc.2014.05.002. Epub 2014 Jun 3.
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.
citation: 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 FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
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;115(2):211-6. doi: 10.1016/j.radonc.2015.04.006. Epub 2015 May 28.