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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT with TACE |
| ||
| SBRT alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter arterial chemoembolization | Procedure | The hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rates | 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 |
| Progression-free survival rates | 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 |
| Local control rates | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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hepatocellular carcinoma patients whose lesion diameter ≤ 5.0 cm
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Sun, Master | Contact | +8613718681094 | +8613718681094 | 519299998@qq.com |
| Xuezhang Duan, PH.D | Contact | 8613621386161 | 8613621386161 | duanxuezhang2006@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuezhang Duan, PH.D | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital) | Recruiting | Beijing | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31455251 | Result | 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. | |
| 29678159 |
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| 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. |
| 27809890 | Result | 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. |
| 30851906 | Result | 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. |
| 22173160 | Result | 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. |