Clinical trial NCT04161287: Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE
Official title: Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Hepatocellular Carcinoma ≤5 cm With or Without Transcatheter Arterial Chemoembolization (TACE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Hepatocellular Carcinoma
Stereotactic Body Radiation Therapy
Transcatheter Arterial Chemoembolization
Keywords: CyberKnife
SBRT
TACE
prognosis
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 330
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hepatocellular carcinoma patients whose lesion diameter ≤ 5.0 cm

Brief summary: The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) 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 ≤ 5.0 cm
* 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 rates
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: Progression-free survival rates
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 rates
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: The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital)
Study officials:
affiliation: Beijing 302 Hospital
name: Xuezhang Duan, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun J, Zhang T, Wang J, Li W, Zhang A, He W, Zhang D, Li D, Ding J, Duan X. Biologically effective dose (BED) of stereotactic body radiation therapy (SBRT) was an important factor of therapeutic efficacy in patients with hepatocellular carcinoma (</=5 cm). BMC Cancer. 2019 Aug 28;19(1):846. doi: 10.1186/s12885-019-6063-9.
citation: Zhang T, Sun J, He W, Li H, Piao J, Xu H, Duan X. Stereotactic body radiation therapy as an effective and safe treatment for small hepatocellular carcinoma. BMC Cancer. 2018 Apr 20;18(1):451. doi: 10.1186/s12885-018-4359-9.
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: Takayasu K, Arii S, Kudo M, Ichida T, Matsui O, Izumi N, Matsuyama Y, Sakamoto M, Nakashima O, Ku Y, Kokudo N, Makuuchi M. Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines. J Hepatol. 2012 Apr;56(4):886-92. doi: 10.1016/j.jhep.2011.10.021. Epub 2011 Dec 13.