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New clinical trial design in precision medicine:discovery,development and direction

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Signal Transduction and Targeted Therapy 2024年第4期9卷 1293-1321页

作者： Xiao-Peng Duan Bao-Dong Qin Xiao-Dong Jiao Ke Liu Zhan Wang Yuan-Sheng Zang Department of Medical oncology Changzheng HospitalNaval Medical UniversityShanghaiChina

In the era of precision medicine,it has been increasingly recognized that individuals with a certain disease are complex and different from each *** to the underestimation of the significant heterogeneity across participants in traditional"one-sizefits-all"trials,patient-centered trials that could provide optimal therapy customization to individuals with specific biomarkers were developed including the basket,umbrella,and platform trial designs under the master protocol *** recent years,the successive FDA approval of indications based on biomarker-guided master protocol designs has demonstrated that these new clinical trials are ushering in tremendous *** the rapid increase in the number of basket,umbrella,and platform trials,the current clinical and research understanding of these new trial designs,as compared with traditional trial designs,remains *** majority of the research focuses on methodologies,and there is a lack of in-depth insight concerning the underlying biological logic of these new clinical trial ***,we provide this comprehensive review of the discovery and development of basket,umbrella,and platform trials and their underlying logic from the perspective of precision ***,we discuss future directions on the potential development of these new clinical design in view of the"Precision Pro","Dynamic Precision",and"Intelligent Precision".This review would assist trial-related researchers to enhance the innovation and feasibility of clinical trial designs by expounding the underlying logic,which be essential to accelerate the progression of precision medicine.

关键词： clinical approval successive

New perspectives on biology,disease progression,and therapy response of head and neck cancer gained from single cell RNA sequencing and spatial transcriptomics

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oncology Research 2024年第1期32卷 1-17页

作者： GERWIN HELLER THORSTEN FUEREDER ALEXANDER MICHAEL GRANDITS ROTRAUD WIESER Division of oncology Department of Medicine IMedical University of ViennaVienna1090Austria Ludwig Boltzmann Institute for Hematology and oncology Medical University of ViennaVienna1090Austria

Head and neck squamous cell carcinoma(HNSCC)is one of the most frequent cancers *** main risk factors are consumption of tobacco products and alcohol,as well as infection with human papilloma *** therapeutic options comprise surgery,radiation,chemotherapy,targeted therapy through epidermal growth factor receptor inhibition,and immunotherapy,but outcome has remained unsatisfactory due to recurrence rates of~50%and the frequent occurrence of second *** availability of the human genome sequence at the beginning of the millennium heralded the omics era,in which rapid technological progress has advanced our knowledge of the molecular biology of malignant diseases,including HNSCC,at an unprecedented ***,microarray-based methods,followed by approaches based on next-generation sequencing,were applied to study the genetics,epigenetics,and gene expression patterns of bulk *** recently,the advent of single-cell RNA sequencing(scRNAseq)and spatial transcriptomics methods has facilitated the investigation of the heterogeneity between and within different cell populations in the tumor microenvironment(e.g.,cancer cells,fibroblasts,immune cells,endothelial cells),led to the discovery of novel cell types,and advanced the discovery of cell-cell communication within *** review provides an overview of scRNAseq,spatial transcriptomics,and the associated bioinformatics methods,and summarizes how their application has promoted our understanding of the emergence,composition,progression,and therapy responsiveness of,and intercellular signaling within,HNSCC.

关键词： Head and neck squamous cell carcinoma Tumor microenvironment Immunotherapy Gene expression Omics

Chinese Medicine Prolongs Overall Survival of Chinese Patients with Advanced Gastric Cancer: Treatment Pattern and Survival Analysis of a 20-Year Real-World Study

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Chinese Journal of Integrative Medicine 2024年第6期30卷 489-498页

作者： CAO Ni-da ZHU Xiao-hong MA Fang-qi XU Yan DONG Jia-huan QIN Meng-meng LIU Tian-shu ZHU Chun-chao GUO Wei-jian DING Hong-hua GUO Yuan-biao LIU Li-kun SONG Jin-jie WU Ji-ping CHENG Yue-lei ZENG Lin ZHAO Ai-guang oncology Department I Longhua Hospital Shanghai University of Traditional Chinese MedicineShanghai200032China oncology Department Zhongshan HospitalFudan UniversityShanghai200032China Gastrointestinal Surgery Department Renji HospitalShanghai Jiaotong University School of MedicineShanghai200127China oncology Department Fudan University Shanghai Cancer CenterShanghai200032China oncology Department Shanghai General HospitalShanghai Jiaotong University School of MedicineShanghai200080China Traditional Chinese Medicine Department Ruijin HospitalShanghai Jiaotong University School of MedicineShanghai200025China oncology Department Shanxi Traditional Chinese Medicine HospitalTaiyuan030012China oncology Department Xiyuan HospitalChina Academy of Chinese Medical ScienceBeijing102445China oncology Department Yunnan Province Hospital of Traditional Chinese MedicineKunming650021China oncology Department Shuguang HospitalShanghai University of Traditional Chinese MedicineShanghai201203China Shanghai NewCore Biotechnology Co. Ltd.Shanghai200240China

Objective To describe the treatment patterns and survival status of advanced gastric cancer(AGC)in China in the past two decades,and objectively evaluate the impact of standardized Chinese medicine(CM)treatment on the survival of AGC *** This multicenter registry designed and propensity score analysis study described the diagnosis characteristics,treatment-pattern development and survival status of AGC from 10 hospitals in China between January 1,2000 and July 31,*** survival(OS)was evaluated between non-CM cohort(standard medical treatment)and CM cohort(integrated standard CM treatment≥3 months).Propensity score matching(PSM)and inverse probability of treatment weighting(IPTW)were performed to adjust any difference in average outcomes for *** A total of 2,001 patients histologically confirmed locally advanced and/or metastasis stomach and gastroesophageal junction adenocarcinoma were *** them,1,607 received systemic chemotherapy,215(10.74%)accepted molecular targeted therapy,44(2.2%)received checkpoint inhibitor therapy,and 769(38.43%)received ***-drug regimen was the main choice for first-line treatment,with fluoropyrimidine plus platinum as the most common regimen(530 cases,60.09%).While 45.71%(16 cases)of patients with HER2 amplification received trastuzumab in *** application of apatinib increased(33.33%)in *** application of checkpoint inhibitors has increased since *** analysis showed that Lauren mixed type(P=0.017),cycles of first-line treatment>6(P=0.000),CM(P=0.000),palliative gastrectomy(P=0.000),trastuzumab(P=0.011),and apatinib(P=0.008)were independent prognostic factors for the OS of *** PSM and IPTW,the median OS of CM cohort and non-CM cohort was 18.17 and 12.45 months,respectively(P<0.001).Conclusions In real-world practice for AGC in China,therapy choices consisted with ***-drug regimen was the main first-line *** CM treatment was an independent

关键词： advancedgastriccancer real-world study treatment pattern survival analysis Chinese medicine

Colorectal cancer and dormant metastases:Put to sleep or destroy?

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World Journal of Gastrointestinal oncology 2024年第6期16卷 2304-2317页

作者： Marina A Senchukova Department of oncology Orenburg State Medical UniversityOrenburg 460000Russia

After reading the review by An et al“Biological factors driving colorectal cancer metastasis”,which covers the problem of the metastasis of colorectal cancer(CRC),I had a desire to discuss with readers one of the exciting problems associated with dormant *** deaths from CRCs are caused by metastases,which can be detected both at diagnosis of the primary tumor and several years or even decades after *** is because tumor cells that enter the bloodstream can be destroyed by the immune system,cause metastatic growth,or remain dormant for a long *** tumor cells may not manifest themselves throughout a person’s life or,after some time and under appropriate conditions,may give rise to the growth of *** this editorial,we will discuss the most important features of dormant metastases and the mechanisms of premetastatic niche formation,as well as factors that contribute to the activation of dormant metastases in *** will pay special attention to the possible mechanisms involved in the formation of circulating tumor cell complexes and the choice of therapeutic strategies that promote the dormancy or destruction of tumor cells in CRCs.

关键词： Circulating tumor cells Colorectal cancer Disseminated tumor cells Dormant metastases Metastases Premetastatic niche

Concurrent chemoradiotherapyof different radiation doses and different irradiation fields for locally advanced thoracic esophageal squamous cell carcinoma:A randomized,multicenter,phase Ⅲ clinical trial

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Cancer Communications 2024年第10期44卷 1173-1188页

作者： Jian Zhang Minghao Li Kaixian Zhang Anping Zheng Guang Li Wei Huang Shaoshui Chen Xiangming Chen Xiaomin Li Yanxing Sheng Xinchen Sun Liping Liu Xiaowei Liu Jie Li Jun Wang Hong Ge Shucheng Ye Qingsong Pang Xianwen Zhang Shengbin Dai Richard Yu Wendong Gu Mingming Dai Gaowa Siqin Yunwei Han Xiaolin Ge Xin Yuan Yongjing Yang Haiwen Zhu Juan Pu Lihua Dong Xiangdong Sun Jundong Zhou Weidong Mao Fei Gao Haiqun Lin Heyi Gong Tao Zhou Zhenjiang Li Hongsheng Li Zhongtang Wang Baosheng Li Department of oncology Central Hospital Affiliated to Shandong First Medical UniversityJinanShandongP.R.China Department of Radiation oncology Shandong Cancer Hospital and InstituteShandong First Medical University and Shandong Academy of Medical SciencesJinanShandongP.R.China Department of oncology Tengzhou Central People’s HospitalTengzhouShandongP.R.China Department of Radiation oncology Anyang Tumor HospitalAnyangHenanP.R.China Department of Radiation oncology the First Hospital of China Medical UniversityShenyangLiaoningP.R.China Department of oncology Binzhou Medical University HospitalBinzhouShandongP.R.China Department of oncology Taian CentralHospitalTaianShandongP.R.China Department of Radiation oncology Shanxi Province Cancer HospitalTaiyuanShanxiP.R.China Department of oncology Liaocheng People’s HospitalLiaochengShandongP.R.China Department of Radiation oncology the First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsuP.R.China Department of oncology Jining First People′s HospitalJiningShandongP.R.China Department of oncology the Affiliated Hospital of Jining Medical UniversityJiningShandongP.R.China Department of Radiation oncology the Fourth Hospital of Hebei Medical UniversityHebei Clinical Research Center for Radiation OncologyShijiazhuangHebeiP.R.China Department of Radiation oncology the Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Department of Radiation oncology Tianjin Medical University Cancer Institute and HospitalNational Clinical Research Center for CancerKey Laboratory ofCancer Prevention and TherapyTianjin’s ClinicalResearch Center for CancerTianjinP.R.China Department of oncology Subei People’s Hospital of Jiangsu ProvinceYangzhouJiangsuP.R.China Department of oncology Taizhou People’s Hospital of Jiangsu ProvinceTaizhouZhejiangP.R.China Department of Radiation oncology the Affiliated Hospital of Inner Mongolia Medical UniversityHohhotInner MongoliaP.R.China Department of Radiation O

Background:Concurrent chemoradiotherapy(CCRT)is the standard treatment for locally advanced esophageal squamous cell carcinoma(ESCC).However,the optimal radiotherapy regimen,particularly in terms of total dose and planned range of irradiation field,remains *** phase III clinical trial aimed to compare the survival benefits between different radiation doses and different target ***:This trial compared two aspects of radiation treatment,total dose and field,using a two-by-two factorial *** high-dose(HD)group received 59.4 Gy radiation,and the standard-dose(SD)group received 50.4 *** involved field irradiation(IFI)group and elective nodal irradiation(ENI)group adopted different irradiation *** participants were assigned to one of the four groups(HD+ENI,HD+IFI,SD+ENI and SD+IFI).The primary endpoint was overall survival(OS),and the secondary endpoints included progressionfree survival(PFS).The synergy indexwas used to measure the interaction effect between dose and ***:The interaction analysis did not reveal significant synergistic effects between the dose and irradiation *** comparison to the target field,patients in IFI or ENI showed similar OS(hazard ratio[HR]=0.99,95%CI:0.80-1.23,p=0.930)and PFS(HR=1.02,95%CI:0.82–1.25).TheHDtreatment did not show significantly prolonged OS compared with SD(HR=0.90,95%CI:0.72–1.11,p=0.318),but it suggested improved PFS(25.2 months to 18.0 months).Among the four groups,the HD+IFI group presented the best survival,while the SD+IFI group had the worst *** significant difference in the occurrence of severe adverse events was found in dose or field ***:IFI demonstrated similar treatment efficacy to ENI in CCRT of *** HD demonstrated improved PFS,but did not significantly improve *** dose escalation based on IFI(HD+IFI)showed better therapeutic efficacy than the current recommendation(SD+ENI)and is worth further validation.

关键词： clinical trial concurrent chemoradiotherapy elective nodal radiation esophageal squamous cell carcinoma high dose radiation involved field radiation overall survival standard dose radiation

Predictive value of positive lymph node ratio in patients with locally advanced gastric remnant cancer

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World Journal of Gastrointestinal oncology 2024年第3期16卷 833-843页

作者： Meng Zhuo Lei Tian Ting Han Teng-Fei Liu Xiao-Lin Lin Xiu-Ying Xiao Department of oncology Renji HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200127China Department of oncology Hebei General HospitalShijiazhuang 050051Hebei ProvinceChina

BACKGROUND Traditional lymph node stage(N stage)has limitations in advanced gastric remnant cancer(GRC)patients;therefore,establishing a new predictive stage is *** To explore the predictive value of positive lymph node ratio(LNR)according to clinicopathological characteristics and prognosis of locally advanced *** Seventy-four patients who underwent radical gastrectomy and lymphadenectomy for locally advanced GRC were retrospectively *** relationship between LNR and clinicopathological characteristics was *** survival analysis was performed using Kaplan-Meier survival curves and Cox regression *** Number of metastatic LNs,tumor diameter,depth of tumor invasion,Borrmann type,serum tumor biomarkers,and tumor-node-metastasis(TNM)stage were correlated with LNR stage and N *** analysis revealed that the factors affecting survival included tumor diameter,anemia,serum tumor biomarkers,vascular or neural invasion,combined resection,LNR stage,N stage,and TNM stage(all P<0.05).The median survival time for those with LNR0,LNR1,LNR2 and LNR3 stage were 61,31,23 and 17 mo,respectively,and the differences were significant(P=0.000).Anemia,tumor biomarkers and LNR stage were independent prognostic factors for survival in multivariable analysis(all P<0.05).CONCLUSION The new LNR stage is uniquely based on number of metastatic LNs,with significant prognostic value for locally advanced GRC,and could better differentiate overall survival,compared with N stage.

关键词： Gastric remnant cancer Positive lymph node ratio Clinicopathological characteristics Prognosis

Anti-EGFR antibody monotherapy for colorectal cancer with severe hyperbilirubinemia: A case report

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World Journal of Gastrointestinal oncology 2024年第2期16卷 557-562页

作者： Toshiaki Tsurui Yuya Hirasawa Yutaro Kubota Kiyoshi Yoshimura Takuya Tsunoda Department of Medical oncology Showa UniversityTokyo 1428555Japan Department of Clinical Immuno oncology Clinical Research Institute of Clinical Pharmacology and TherapeuticsShowa UniversityTokyo 1578577Japan

BACKGROUND Hyperbilirubinemia with hepatic metastases is a common complication and a poor prognostic factor for colorectal cancer(CRC).Effective drainage is often im-possible before initiating systemic chemotherapy,owing to the liver’s diffuse metastatic ***,an appropriate chemotherapeutic approach for the treatment of hyperbilirubinemia is currently *** SUMMARY The patient,a man in his 50s,presented with progressive fatigue and severe *** tomography revealed multiple hepatic masses with thick-ened walls in the sigmoid colon,which was pathologically confirmed as a well-differentiated *** RAS or BRAF mutations were *** Eastern Cooperative oncology Group(ECOG)performance status(PS)score was *** drainage was impossible due to the absence of a dilated bile duct,and panitumumab monotherapy was promptly ***,the bilirubin level decreased and then normalized,and the patient’s PS improved to zero ECOG score after four cycles of therapy without significant adverse *** Anti-EGFR antibody monotherapy is a safe and effective treatment for RAS wild-type CRC and hepatic metastases with severe hyperbilirubinemia.

关键词： Colorectal neoplasms Panitumumab Chemotherapy Hyperbilirubinemia Jaundice Case report

Penpulimab,an anti-PD-1 antibody,for heavily pretreated metastatic nasopharyngeal carcinoma:a single-arm phase II study

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Signal Transduction and Targeted Therapy 2024年第7期9卷 3056-3062页

作者： Xiaozhong Chen Wei Wang Qingfeng Zou Xiaodong Zhu Qin Lin Yi Jiang Yan Sun Liangfang Shen Lin Wang Guorong Zou Xiaoyan Lin Shaojun Lin Minying Li Ying Wang Ruilian Xu Rui Ao Rensheng Wang Haifeng Lin Shuang Huang Tingting Xu Wenting Li Mengying Xia Yu Xia Zhongmin Wang Baiyong Li Jingao Li Chaosu Hu Department of Radiation oncology Cancer Hospital of the University of ChineseAcademy of Sciences(Zhejiang Cancer Hospital)HangzhouChina Gastroenterology and Urology Department II Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of MedicineCentral South UniversityChangshaChina Clinical Research Center for Gastrointestinal Cancer in Hunan Province ChangshaChina Department of Medical oncology Affiliated Cancer Hospital&Institute of Guangzhou Medical UniversityGuangzhouChina Department of Radiation oncology Guangxi Medical University Affiliated Tumor Hospital&Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor(Guangxi Medical University)Ministry of Education&Guangxi Key Laboratory of Early Prevention and Treatment for Regional High Frequency TumorGuangxi Medical UniversityNanningChina Department of Radiation oncology Cancer CenterThe First Affiliated Hospital of Xiamen UniversityXiamenChina Department of Medical oncology Cancer Hospital of Shantou University Medical CollegeShantouChina Department of Radiation oncology Peking University Cancer Hospital&InstituteBeijingChina Department of oncology Xiangya Hospital Central South UniversityChangshaChina Department of Medical oncology Hainan General HospitalHainan Affiliated Hospital of Hainan Medical UniversityHaikouChina Department of oncology The Affiliated Panyu Central Hospital of Guangzhou Medical UniversityGuangzhouChina Department of Medical oncology Fujian Medical University Union HospitalFuzhouChina Department of Radiation oncology Clinical Oncology School of Fujian Medical UniversityFujian Cancer HospitalFuzhouChina Department of Radiation Therapy for Thoracic Tumors Zhongshan City People’s HospitalZhongshanChina Tumor Radiotherapy Center Chongqing University Cancer HospitalChongqing Cancer HospitalChongqing Cancer InstituteChongqingChina Department of oncology Shenzhen People’s Hospital(The Second Clinical Medical CollegeJinan UniversityThe First Affiliated HospitalSo

Penpulimab is an anti-programmed cell death-1(PD-1)IgG1 antibody with no Fc gamma receptor(FcγR)binding activity,and thus theoretically reduced immune-related adverse events(irAEs)while maintaining *** single-arm,phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma(NPC)who had failed two or more lines of previous systemic *** received 200-mg penpulimab intravenously every 2 weeks(4 weeks per cycle)until disease progression or intolerable *** primary endpoint was objective response rate(ORR)per RECIST(version 1.1),as assessed by an independent radiological review *** secondary endpoints included progression-free survival(PFS)and overall survival(OS).One hundred thirty patients were enrolled and 125 were efficacy *** the data cutoff date(September 28,2022),1 patient achieved complete response and 34 patients attained partial *** ORR was 28.0%(95%CI 20.3–36.7%).The response was durable,with 66.8%still in response at 9 ***-three patients(26.4%)were still on *** median PFS and OS were 3.6 months(95%CI=1.9–7.3 months)and 22.8 months(95%CI=17.1 months to not reached),***(7.6%)patients experienced grade 3 or higher *** has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients,supporting further clinical development as third-line treatment of metastatic NPC.

关键词： metastatic nasopharyngeal supporting

STING agonist-conjugated metal-organic framework induces artificial leukocytoid structures and immune hotspots for systemic antitumor responses

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National Science Review 2024年第7期11卷 189-204页

作者： Taokun Luo Xiaomin Jiang Yingjie Fan Eric Yuan Jinhong Li Langston Tillman Wenbin Lin Department of Chemistry University of Chicago Department of Radiation and Cellular oncology and the Ludwig Center for Metastasis Research University of Chicago

Radiotherapy is widely used for cancer treatment, but its clinical utility is limited by radioresistance and its inability to target metastases. Nanoscale metal-organic frameworks(MOFs) have shown promise as high-Z nanoradiosensitizers to enhance radiotherapy and induce immunostimulatory regulation of the tumor microenvironment. We hypothesized that MOFs could deliver small-molecule therapeutics to synergize with radiotherapy for enhanced antitumor efficacy. Herein, we develop a robust nanoradiosensitizer,GA-MOF, by conjugating a STING agonist, 2,3-cyclic guanosine monophosphate–adenosine monophosphate(GA), on MOFs for synergistic radiosensitization and STING activation. GA-MOF demonstrated strong anticancer efficacy by forming immune-cell-rich nodules(artificial leukocytoid structures) and transforming them into immunostimulatory hotspots with radiotherapy. Further combination with an immune checkpoint blockade suppressed distant tumors through systemic immune activation. Our work not only demonstrates the potent radiosensitization of GA-MOF, but also provides detailed mechanisms regarding MOF distribution, immune regulatory pathways and long-term immune effects.

关键词： metal-organic framework radiosensitization STING agonist artificial leukocytoid structures immune hotspots immunotherapy nanomedicine