Clinical trial NCT04512846: Comparison of Efficacy in SBRT of Large HCC With or Without TACE
Official title: Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Large HCC Patients
Stereotactic Body Radiation Therapy
Transcatheter Arterial Chemoembolization
Keywords: CyberKnife
SBRT
large HCC
prognosis
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 100
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 large HCC patients who receive SBRT with or without TACE.

Brief summary: The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.


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
* single lesion and longest tumor diameter were 5-10cm;
* CP-A or B classification;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
* unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
* 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:

* tumor thrombus;
* lymph node involvement;
* extrahepatic metastasis.

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: Su TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9.
citation: Wong TC, Chiang CL, Lee AS, Lee VH, Yeung CS, Ho CH, Cheung TT, Ng KK, Chok SH, Chan AC, Dai WC, Wong FC, Luk MY, Leung TW, Lo CM. Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. Surg Oncol. 2019 Mar;28:228-235. doi: 10.1016/j.suronc.2019.01.006. Epub 2019 Jan 29.
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.