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Transarterial chemoembolization with PD-(L)1 inhibitors plus molecular targeted therapies for hepatocellular carcinoma(CHANCE001)

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Signal Transduction and Targeted Therapy 2023年第3期8卷 1198-1207页

作者： hai-Dong Zhu hai-Liang Li Ming-sheng Huang wei-Zhu Yang Guo-Wen Yin bin-Yan Zhong jun-Hui Sun Zhi-cheng Jin jian-jian chen Nai-jian Ge Wen-bin Ding Wen-Hui Li Jin-Hua Huang wei Mu Shan-Zhi Gu Jia-Ping Li Hui Zhao Shu-wei Wen Yan-Ming Lei Yu-sheng Song Chun-wang Yuan wei-Dong wang Ming Huang wei Zhao jian-bing Wu Song wang xu Zhu jian-jun Han wei-Xin Ren Zai-Ming Lu Wen-Ge Xing Yong Fan hai-Lan Lin Zi-Shu Zhang Guo-Hui xu Wen-Hao Hu Qiang Tu Hong-Ying Su Chuan-sheng Zheng Yong chen xu-Ya Zhao Zhu-Ting Fang Qi wang Jin-wei Zhao Ai-bing xu jian xu Qing-Hua Wu Huan-Zhang Niu jian wang Feng Dai Dui-Ping Feng Qing-Dong Li Rong-Shu shi Jia-Rui Li Guang Yang hai-bin shi jian-Song Ji Yu-E Liu Zheng Cai Po Yang Yang Zhao Xiao-Li Zhu Li-Gong Lu Gao-jun Teng Center of Interventional Radiology&Vascular Surgery Department of RadiologyZhongda HospitalMedical SchoolSoutheast UniversityNanjing 210009China Department of Minimally invasive Intervention The Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhou 450008China Department of Interventional Radiology the Third Affiliated HospitalSun Yat-Sen UniversityGuangzhou 510630China Department of Interventional Radiology Union Hospital of Fujian Medical UniversityFuzhou 350001China Department of Interventional Radiology Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Research&The Affiliated Cancer Hospital of Nanjing Medical UniversityNanjing 210009China Department of Interventional Radiology The First Affiliated Hospital of Soochow UniversitySoochow UniversitySuzhou 215006China Hepatobiliary and Pancreatic Interventional Treatment Center Division of Hepatobiliary and Pancreatic SurgeryThe First Affiliated HospitalZhejiang University School of MedicineHangzhou 310003China Department of Interventional Radiology Eastern Hospital of Hepatobiliary SurgeryNavy Medical University(Second Military Medical University)Shanghai 200438China Department of Interventional Radiology Nantong First People’s HospitalNantong 226001China Department of Interventional Radiology Yancheng Third People’s HospitalYancheng 224008China Department of Minimally Invasive Interventional Therapy Sun YatSen University Cancer CenterGuangzhou 510060China Department of Vascular Surgery Southwest HospitalThird Military Medical University(Army Medical University)Chongqing 400038China. Department of Interventional Radiology Hunan Cancer HospitalChangsha 410031China Department of Interventional Oncology The First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou 510080China Department of Interventional Radiology The Hospital of Nantong UniversityNantong 226001China Department of Interventional Therapy Shanxi Tumor HospitalTaiyuan 030001China Department of Interventional Radiology Tibet Autonomous Region People’s

There is considerable potential for integrating transarterial chemoembolization(TACE),programmed death-(ligand)1(PD-[L]1)inhibitors,and molecular targeted treatments(MTT)in hepatocellular carcinoma(HCC).It is necessary to investigate the therapeutic efficacy and safety of TACE combined with PD-(L)1 inhibitors and MTT in real-world *** this nationwide,retrospective,cohort study,826 HCC patients receiving either TACE plus PD-(L)1 blockades and MTT(combination group,n=376)or TACE monotherapy(monotherapy group,n=450)were included from January 2018 to May *** primary endpoint was progression-free survival(PFS)according to modified *** secondary outcomes included overall survival(OS),objective response rate(ORR),and *** performed propensity score matching approaches to reduce bias between two *** matching,228 pairs were included with a predominantly advanced disease *** PFS in combination group was 9.5 months(95%confidence interval[CI],8.4-11.0)versus 8.0 months(95%CI,6.6-9.5)(adjusted hazard ratio[HR],0.70,P=0.002).OS and ORR were also significantly higher in combination group(median OS,19.2[16.1-27.3]vs.15.7 months[13.0-20.2];adjusted HR,0.63,P=0.001;ORR,60.1%vs.32.0%;Pbination and monotherapy groups,*** results suggest that TACE plus PD-(L)1 blockades and MTT could significantly improve PFS,OS,and ORR versus TACE monotherapy for Chinese patients with predominantly advanced HCC in real-world practice,with an acceptable safety profile.

关键词： hepatocellular targeted matching

Two annular CsI(Tl) detector arrays for the charged particle telescopes

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Nuclear Science and Techniques 2023年第10期34卷 158-165页

作者： Hong-Yu Zhu jian-Ling Lou Yan-Lin Ye Li-sheng Yang Bo-Long Xia Kang wei Ying chen wei-Liang Pu Zi-Yao Hu Hao-Yu Ge Jia-Hao chen Kai Ma Wen-Wu Wan Hooi-Jin Ong Yan-Yun Yang shi-wei xu Kang wang Fang-Fang Duan jun-bin Ma Zhen Bai Peng Ma Ruo-Fu chen School of Physics and State Key Laboratory of Nuclear Physics and Technology Peking UniversityBeijing 100871China Institute of Modern Physics Chinese Academy SciencesLanzhou 730000China

In this study,we constructed two annular detector arrays comprising 24 wedge-shaped CsI(Tl) crystals,and tested them using anαsource and radioactive beams of ^(14-16) Con a CD_2 *** compared the properties of a CsI(Tl) crystal encapsulated with various reflectors,revealing that using the 80-μm-thick ESR film to pack the CsI(Tl) crystal yielded the largest light output with the smallest non-uniformity in light output (ΔLO).For the 24 CsI(Tl) detectors with the 80-μm-thick ESR films,the average energy resolution improved as the average light output increased;however,it deteriorated as theΔLO value *** form two annular Si-CsI(Tl) telescopes for identifying the light-charged particles,theΔLO value and energy resolution of each CsI(Tl) detector were maintained under 20%and 7.7%,*** telescopes were tested for the first time in a direct nuclear reaction experiment using ^(14-16) C+*** results demonstrated that the Z=1 and Z=2 charged particles were adequately discriminated by the telescopes using the standardΔE-E method.

关键词： Wedge-shaped CsI(Tl)detector Light output non-uniformity Si-CsI(Tl)telescope Particle identification

The heterogeneity of islet autoantibodies and the progression of islet failure in type 1 diabetic patients

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Science China(Life Sciences) 2016年第9期59卷 930-939,938-939+932-937页

作者： Jin Liu Lingling Bian Li Ji Yang chen Heng chen Yong Gu bingqin Ma wei Gu Xinyu xu Yun shi jian wang Dalong Zhu Zilin Sun jianhua Ma Hui Jin Xing shi Heng Miao bing Xin Yan Zhu Zhenwen Zhang Ruifang Bu Lan xu Guangde shi wei Tang wei Li Dongmei Zhou jun Liang Xingbo cheng Bimin shi Jixiang Dong Ji Hu chen Fang Shao Zhong weinan Yu weiping Lu chenguang Wu Li Qian jiancheng Yu Jialin Gao Xiaoqiang Fei Qingqing Zhang xueqin wang shiwei Cui Jinluo cheng Ning xu Guofeng wang Guoqing Han Chunrong xu Yun Xie Minmin An wei Zhang Zhixiao wang Yun Cai Qi Fu Yu Fu Shuai Zheng Fan Yang Qingfang Hu Hao Dai Yu Jin Zheng Zhang Kuanfeng xu Yifan Li Jie shen Hongwen Zhou wei He xuqin Zheng Xiao Han Liping Yu Jinxiong she Mei Zhang Tao Yang Department of Endocrinology and Metabolism First Affiliated Hospital of Nanjing Medical University Nanjing 210029 China Barbara Davis Center for Childhood Diabetes University of Colorado Denver Aurora Colorado 80045 USA Key Laboratory of Human Functional Genomics of jiangsu Province Nanjing Medical University Nanjing 210000 China Department of Isotopic Laboratory of Nanjing Medical University Nanjing 210000 China HLA Laboratory of jiangsu Province People's Hospital Nanjing 210029 China Department of Endocrinology and Metabolism Nanjing General Hospital of Nanjing Military Command Nanjing 210002 China Department of Endocrinology and Metabolism Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing 210008 China Department of Endocrinology and Metabolism Zhongda Hospital Southeast University Nanjing 210009 China Department of Endocrinology and Metabolism Nanjing First Hospital Nanjing 210000 China Department of Endocrinology and Metabolism Nanjing Children's Hospital Nanfing 210008 China Department of Endocrinology and Metabolism The Second Affiliated Hospital of Nanjing Medical University Nanjing 210011 China Department of Endocrinology and Metabolism Nanjing Governmental Hospital Nanjing 210008 China Department of Endocrinology and Metabolism Northern Jiangsu People's Hospital Yangzhou 225001 China Department of Endocrinology and Metabolism Wuxi People's Hospital Wuxi 214023 China Department of Endocrinology and Metabolism Jiangsu Jiangyin People's Hospital Wuxi 214400 China Department of Endocrinology and Metabolism The Affiliated Hospital of Xuzhou Medical College Xuzhou 221006 China Department of Endocrinology and Metabolism Xuzhou Central Hospital Xuzhou 221009 China Department of Endocrinology and Metabolism The First Affiliated Hospital of Soochow University Suzhou 215006 China Department of Endocrinology and Metabolism The Second Affiliated Hospital of Soochow University Suzhou 215004 China Department of Endocri

Type 1 diabetes mellitus is heterogeneous in many facets. The patients suffered from type 1 diabetes present several levels of islet function as well as variable number and type of islet-specific autoantibodies. This study was to investigate prevalence and heterogeneity of the islet autoantibodies and clinical phenotypes of type 1 diabetes mellitus; and also discussed the process of islet failure and its risk factors in Chinese type 1 diabetic patients. A total of 1,291 type 1 diabetic patients were enrolled in this study. Demographic information was collected. Laboratory tests including mixed-meal tolerance test, human leukocyte antigen alleles, hemoglobin A1 c, lipids, thyroid function and islet autoantibodies were conducted. The frequency of islet-specific autoantibody in newly diagnosed T1 DM patients(duration shorter than half year) was 73% in East China. According to binary logistic regressions, autoantibody positivity, longer duration and lower Body Mass Index were the risk factors of islet failure. As the disease developed, autoantibodies against glutamic acid decarboxylase declined as well as the other two autoantibodies against zinc transporter 8 and islet antigen 2. The decrease of autoantibodies was positively correlated with aggressive beta cell destruction. Autoantibodies can facilitate the identification of classic T1 DM from other subtypes and predict the progression of islet failure. As there were obvious heterogeneity in autoantibodies and clinical manifestation in different phenotypes of the disease, we should take more factors into consideration when identifying type 1 diabetes mellitus.

关键词： autoantibodies heterogeneity islet failure type 1 diabetes

Comparison of long-term clinical outcome after successful implantation of FIREBIRD and CYPHER sirolimus-eluting stents in daily clinical practice： analysis of a large single-center registry

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Chinese Medical Journal 2011年第7期124卷 990-996页

作者： xu Bo dou Ke-fei YANG Yue-jin chen Ji-lin QIAO Shu-bin wang Yang LI jian-jun QIN xue-wen YAO Min LIU hai-bo WU Yong-jian chen Jue YUAN Jin-qing YOU shi-jie LI wei GAO Run-lin Cardiac Catheterization Lab (xu B) Cardiovascular Institute and Fu Wai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100037 China Department of Cardiology Cardiovascular Institute and Fu Wai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100037 China

Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.

关键词： clinical outcome sirolimus-eluting stent CYPHER stent FIREBIRD stent

Comparison of long-term clinical outcome after successful implantation of Firebird sirolimus-and Taxus paclitaxel-eluting stents in Chinese population： analysis of a large single center registry

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Chinese Medical Journal 2010年第7期123卷 810-815页

作者： dou Ke-fei xu Bo YANG Yue-jin chen Ji-lin QIAO Shu-bin wang Yang LI jian-jun QIN xue-wen YAO Min LIU hai-bo WU Yong-jian chen Jue YUAN Jin-qing YOU shi-jie LI wei GAO Run-lin Department of Cardiology Cardiovascular Institute and Fu Wai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100037 China

Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） seemed superior to paclitaxel-eluting stent （PES） in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese popuation is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAxuS PES in Chinese *** From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES （Firebird SES 2274; Taxus PES 836） implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 95%CI 0.26-0.54）, TVR （HR 0.51,95%CI 0.38-0.68） and MACE （HR 0.53, 95%CI 0.41-0.68）. The results after propensity match were consistent with that before matching, lower risk of TLR （HR 0.33, 95%CI 0.19-0.58）, TVR （HR 0.41, 95%CI 0.26-0.64）, MACE （HR 0.48, 95%CI 0.33-0.68） in Firebird *** Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.

关键词： treatment outcome Firebird sirolimus-eluting stent Taxus paclitaxel-eluting stent

Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation： results from a large single-center database

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Chinese Medical Journal 2009年第19期122卷 2261-2267页

作者： GAO Run-lin xu Bo chen Ji-lin YANG Yue-jin QIAO Shu-bin wang Yang dou Ke-fei QIN xue-wen YAO Min LIU hai-bo WU Yong-jian YUAN Jin-qing chen Jue YOU shi-jie DAI jun MA wei-hua LI wei Department of Cardiology Cardiovascular Institute & Fu Wai Hospital Chinese Academy of Medical Sciences Peking Union Medical College Beijing 100037 China Catheterization Laboratory Cardiovascular Institute & Fu Wai Hospital Chinese Academy of Medical Sciences Peking Union Medical College Beijing 100037 China Division of Biometrics Cardiovascular Institute & Fu Wai Hospital Chinese Academy of Medical Sciences Peking Union Medical College Beijing 100037 China

Background In response to the increasing concern with the safety of the drug-eluting stent （DES）, the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population. Methods All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent （BMS） in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors. Results Overall, there were 1465 patients （20.2%） who had undergone an implantation of only BMS, and 5769 patients （79.8%） of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis （definite and probable） of the two groups （1.06% vs 1.21%, P=0.8580）. Although rates of mortality and myocardial infarction （MI） during the 2-year follow-up period had not differed significantly, rates of death/MI （3.0% vs 4.5%, P=0.0263）, target-lesion revascularization （TLR, 3.2% vs 8.5, P=0.0001）, target-vessel revascularization （TVR, 5.8% vs 9.5%, P 〈0.0001） and any revascularization （10.0% vs 13.3%, P=0.0066） were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group. Conclusions During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.

关键词： stent drug eluting bare metal registry propensity score

Long-term clinical outcomes after bioabsorbable polymer- and durable polymer-based sirolimus-eluting stents implantation： two-year follow-up results from a large single-center database

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Chinese Medical Journal 2009年第6期122卷 681-686页

作者： LIU hai-bo xu Bo YANG Yue-jin wang Yang QIN xue-wen YAO Min WU Yong-jian YUAN Jin-qing chen Jue YOU shi-jie DAI jun MA wei-hua LI jian-jun QIAO Shu-bin chen Ji-lin LI wei GAO Run-lin Department of Cardiology Fu Wai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100037 China

Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The FIREBIRD stent （coated with durable polymer） and the EXCEL stent （coated with bioabsorbable polymer） are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term （6-month） angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between june 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types （EXCEL or FIREBIRD） used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target vessel revascularization） and stent thrombosis during a 2-year follow-up period were compared between the two groups.Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group （HR 0.84, 95%CI0.50-1.43）, whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% （HR 0.74, 95%CI0.30-0.85）, 1.8% vs 1.3% （HR 1.41,95%CI 0.45-4.43） and 2.5% vs 4.0% （HR 0.62, 95%CI0.28-0.37）, respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group （P=0.5610）, whereas the rate of very la

关键词： percutaneous coronary intervention drug-eluting stent bioabsorbable polymer long-term comparative study

Can ＂Hybrid stent implantation＂ improve long-term safety without adversely affecting efficacy when treating multilesion coronary artery disease in the drug-eluting stent era？

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Chinese Medical Journal 2013年第9期126卷 1612-1617页

作者： ZHANG Dong xu Bo dou Ke-fei YANG Yue-jin chen Ji-lin QIAO Shu-bin wang Yang LI jian-jun QIN xue-wen YAO Min LIU hai-bo WU Yong-jian chen Jue YUAN Jin-qing YOU shi-jie LI wei GAO Run-lin Department of Cardiology Department of Catheterization Laboratory Division of Biometrics Fu WaiHospital and Cardiovascular Institute National Center for Cardiovascular Diseases Chinese Academy of Medical Sciences &Peking Union Medical College Beijing 100037 China

Background Though drug-eluting stent （DES） almost solved a problem of restenosis, safety issues related to stent thrombosis are still the major concern of DES. We hypothesized that hybrid stent implantation may decrease the use of DES, probably improving the long-term safety but not affecting efficacy adversely when treating multilesion coronary artery disease in the DES era. Methods From April 2004 to October 2006, 848 patients with multilesion disease underwent hybrid stent implantation. During the same period 5647 patients with multilesion coronary heart disease were treated by exclusive DES implantation in Fu Wai Hospital. According to propensity score matching, we chose 823 pairs of patients with multileison coronary artery disease for inclusion into our study. We obtained the 24-month clinical outcome including death, myocardial infarction （MI）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, MI, and TVR）. We used Cox＇s proportional-hazard models to assess relative risks of all the outcome measures after propensity match. Results At 24 months, patients in the hybrid stent implantation group showed a significantly higher risk of TLR （8.39% vs. 3.28%, HR2.38, 95% Cl. 1.50-3.70）, TVR （11.07% vs. 6.32%,/-/R 1.61, 95% Cl. 1.15-2.27） and MACE （13.75% vs. 8.75%, FIR 1.37, 95% Cl. 1.02-1.85）. No significant difference was apparent in terms of mortality （1.22% vs. 1.70%, HR 0.55, 95% Cl. 0.24-1.25）, MI （1.95% vs. 2.31%, HR0.73, 95% Cl. 0.37-1.42）, or thrombosis （definite＋probable）（0.73% vs. 1.58%, HR0.40, 95% Cl. 0.15-1.05）. Conclusions In patients with multilesion coronary artery disease, the exclusive DES implantation was associated with significantly lower risks of TLR, TVR and MACE, and the hybrid stent implantation did not result in any significant improvements regarding safety issues. Prospective studies are needed to confirm our results.

关键词： multilesion coronary artery disease " hybrid stent implantation " long-term safety " efficacy

Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma:A single-arm, multicenter, prospective study

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Hepatobiliary & Pancreatic Diseases International 2022年第2期21卷 106-112页

作者： Ren-Yi Su Sun-bin Ling Qiao-Nan Shan xu-Yong wei Rui wang Chang-Ku Jia Li Zhuang Tian shen Li-Min Ding Zhi-Dan xu Lai-Bang Luo Li-Bo Sun Guang-Ming Li Tai-shi Fang Nan jiang Kun Zhang Zhao-Jie Su Zhi-hai Peng Ren Lang Tao jiang Qiang He Lin-Sen Ye Yang Yang Yu-Ting He Wen-Zhi Guo Liu-Gen Lan xu-Yong Sun Dong chen Zhi-Shui chen Da-wei Zhou Shao-jun Ye Qi-Fa Ye Min Tian jian-Hua shi Bo wang jiang Liu Qian Lu wei Rao Jin-Zhen Cai Tao Lv Jia-Yin Yang Pu-Sen wang Lin Zhong Jing-sheng Ma Qi-Gen Li sheng-Dong Wu Chang-jiang Lu Cai-De Lu Dong-Hua Zhang xuan wang Zi-Qiang Li Mu-jian Teng jun-Jie Li Wen-Tao jiang jian-Hua Li Quan-Bao Zhang Ning-Qi Zhu Zheng-Xin wang Kang He Qiang Xia Shao-Hua Song Zhi-Ren Fu wei Qiu Guo-Yue Lv Rui-Peng Song Ji-Zhou wang Zheng wang jian Zhou Gang chen Ying-Peng Zhao Li Li Ze-Min Hu Qi-Jie Luo Zhong-Zhou Si bin Xie Xiao-Shun He Zhi-Yong Guo Shu-Sen Zheng Xiao xu Department of Hepatobiliary and Pancreatic Surgery The Center for Integrated Oncology and Precision MedicineAffiliated Hangzhou First People’s HospitalZhejiang University School of MedicineHangzhou 310006China NHC Key Laboratory of Combined Multi-organ Transplantation Hangzhou 310003China Department of Hepatobiliary and Pancreatic Surgery Shulan(Hangzhou)HospitalZhejiang Shuren University School of MedicineHangzhou 310022China Department of Hepatobiliary and Pancreatic Surgery The First Affiliated HospitalZhejiang University School of MedicineHangzhou 310003China Department of Transplantation Jiangxi Provincial People’s Hospital Affiliated to Nanchang UniversityNanchang 330006China Liver Transplantation Center Beijing You’an HospitalCapital Medical UniversityBeijing 100069China Department of Hepatic Surgery National Clinical Research Center for Infectious DiseaseShenzhen Third People’s HospitalThe Second Affiliated Hospital of Southern University of Science and TechnologyShenzhen 518112China Department of General Surgery Xiang’an Hospital of Xiamen UniversityXiamen 361000China Deartment of Hepatobiliary and Pancreaticosplenic Surgery Beijing Chaoyang HospitalCapital Medical UniversityBeijing 100020China Department of Hepatic Surgery and Liver Transplantation Center The Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhou 510630China Department of Hepatobiliary and Pancreatic Surgery The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052China Department of Liver Transplantation The Second Affiliated Hospital of Guangxi Medical UniversityNanning 530000China Institute of Organ Transplantation Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Institute of Hepatobiliary Diseases of Wuhan University Transplant Center of Wuhan UniversityHubei Key Laboratory of Medical Technology on TransplantationZhongnan Hospital of Wuhan UniversityWuhan 430071China Department of Hepatobiliary Surgery The First Affiliated Hos

Mammalian target of rapamycin(m TOR) inhibitor as an attractive drug target with promising antitumor effects has been widely investigated. High quality clinical trial has been conducted in liver transplant(LT) recipients in Western countries. However, the pertinent studies in Eastern world are paucity. Therefore, we designed a clinical trial to test whether sirolimus can improve recurrence-free survival(RFS) in hepatocellular carcinoma(HCC) patients beyond the Milan criteria after LT. This is an open-labeled, single-arm, prospective, multicenter, and real-world study aiming to evaluate the clinical outcomes of early switch to sirolimus-based regimens in HCC patients after LT. Patients with a histologically proven HCC and beyond the Milan criteria will be enrolled. The initial immunosuppressant regimens are center-specifc for the frst 4-6 weeks. The following regimens integrated sirolimus into the regimens as a combination therapy with reduced calcineurin inhibitors based on the condition of patients and centers. The study is planned for 4 years in total with a 2-year enrollment period and a 2-year follow-up. We predict that sirolimus conversion regimen will provide survival benefts for patients particular in the key indicator RFS as well as better quality of life. If the trial is conducted successfully, we will have a continued monitoring over a longer follow-up time to estimate indicator of overall survival. We hope that the outcome will provide better evidence for clinical decision-making and revising treatment guidelines based on Chinese population data.

关键词： Sirolimus Immunosuppressive agents Hepatocellular carcinoma Liver transplantation Conversion