[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624422":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":84,"studyPopulation":75,"armGroups":85,"interventions":99,"overallOfficials":117,"centralContacts":122,"locations":128,"responsibleParty":661,"collaborators":75,"id":663,"slug":75,"hasResults":664,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":75,"eligibilityCriteria":668,"healthyVolunteers":664,"sex":669,"minAge":670,"maxAge":75,"enrollmentInfo":671,"targetDuration":75,"studyType":674,"phases":675,"briefSummary":677,"conditions":678,"keywords":680,"overallStatus":549,"whyStopped":75,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":692},{"fullName":5,"class":6},"Hutchmed","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":54},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)","Investigator-assessed progression-free survival (PFS) Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014). PFS is defined as the time from randomization to PD or death due to any cause, whichever occurs first.","Up to approximately two years",{"measure":14,"description":15,"timeFrame":12},"End of treatment (EOT)","Tumor assessment data will continue to be collected. Tumor assessment data collected after end of treatment (EOT) will be used. Tumor assessment data collected during the study and after EOT will be included in the PFS analysis (treatment policy strategy).",{"measure":17,"description":18,"timeFrame":12},"Systemic antitumor therapy","Use of other systemic antitumor therapy before PD or death (in the absence of PD):Tumor assessment after use of other systemic antitumor therapy will not be included in the analysis. For patients using other anti-tumor therapy before PD or death (in absence of PD), PFS will be censored at the last evaluable tumor assessment before the use of other systematic anti-tumor therapy (hypothetical strategy).",{"measure":20,"description":21,"timeFrame":12},"Overall survival (OS)","OS is defined as the time from randomization to death due to any cause.",{"measure":23,"description":24,"timeFrame":12},"systematic anti-tumor therapy","OS data will continue to be collected after the other systematic anti-tumor therapy, and the OS data collected before and after other systematic anti-tumor therapy will be included in analysis (treatment policy strategy).",{"measure":26,"description":27,"timeFrame":12},"Premature withdrawal from study treatment","OS data will continue to be collected after the patient's premature withdrawal from study treatment, and the OS data collected during the study treatment and after EOT will be included in analysis (treatment policy strategy).",[29,32,35,38,41,44,47,50],{"measure":30,"description":31,"timeFrame":12},"Independent review committee (IRC)-assessed PFS","Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).",{"measure":33,"description":34,"timeFrame":12},"IRC- and investigator-assessed objective response rate (ORR)","Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR)",{"measure":36,"description":37,"timeFrame":12},"IRC- and investigator-assessed complete response rate (CRR)","Complete response (CR) rate is defined as the ratio of patients with who reached complete response (CR)",{"measure":39,"description":40,"timeFrame":12},"IRC- and investigator-assessed duration of response (DoR)","For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first",{"measure":42,"description":43,"timeFrame":12},"IRC- and investigator-assessed clinical benefit rate (CBR)","Defined as the ratio of patients with complete response (CR), partial response (PR), or stable disease (SD)",{"measure":45,"description":46,"timeFrame":12},"IRC- and investigator-assessed time to response (TTR)","Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR)",{"measure":48,"description":49,"timeFrame":12},"Safety Endpoints","* Incidence and severity of treatment-emergent adverse events (TEAEs), incidence of treatment-emergent serious adverse events (TESAEs), incidence of TEAEs leading to permanent discontinuation, dose interruption, and dose reduction, and their correlation to study drug. The severity is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE 6.0).\n* Changes in laboratory tests, vital signs, 12-lead ECG, etc.",{"measure":51,"description":52,"timeFrame":53},"PK characteristics of HMPL-760 in patients with R\u002FR DLBCL when administered in combination with R-GemOx","including but not limited to steady-state plasma concentrations of HMPL-760 pre-dose \\[trough concentrations (Ctrough)\\] and post-dose (C1h and C2h); If possible, a population pharmacokinetic (PPK) model can be used to generate PK parameters. If necessary, it can also be combined with other studies for model analysis.\n\nIf possible, a population pharmacokinetic (PPK) model can be used to generate PK parameters. If necessary, it can also be combined with other studies for model analysis.","At the end of Cycle 4 (each cycle is 21 days)]",[55,58,61,64,66,68,70],{"measure":56,"description":57,"timeFrame":12},"Biomarker assessment","Detect tumor driver gene mutations in tissue and blood samples, such as MYD88 and CD79B, etc, and explore the relationship between their mutation status and drug efficacy.",{"measure":59,"description":60,"timeFrame":12},"To explore the metabolite profile of HMPL-760 in combination with R-GemOx in tumor patients","Human metabolites of HMPL-760 when co-administered with R-GemOx",{"measure":62,"description":63,"timeFrame":12},"Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760","maximum concentration in steady-state (Cmax,ss)",{"measure":62,"description":65,"timeFrame":12},"time to maximum concentration in steady-state (Tmax,ss)",{"measure":62,"description":67,"timeFrame":12},"Area Under the Curve at steady state refers to the area under the plasma concentration-time curve during a dosing interval at steady state conditions (AUC,ss)",{"measure":62,"description":69,"timeFrame":12},"The rate at which the drug is eliminated from the body (CL\u002FF) (if applicable )",{"measure":62,"description":71,"timeFrame":12},"The distribution volume calculated based on the terminal elimination phase (Vz\u002FF )(if applicable)",{"allocation":73,"interventionModel":74,"interventionModelDescription":75,"primaryPurpose":76,"observationalModel":75,"timePerspective":75,"maskingInfo":77},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":78,"maskingDescription":75,"whoMasked":79},"QUADRUPLE",[80,81,82,83],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.\n\nThe target population of this study includes patients with DLBCL who are relapsed or refractory.",[86,93],{"label":87,"type":88,"description":89,"interventionNames":90},"The experimental group","EXPERIMENTAL","Patients will receive HMPL-760 once daily (QD) orally in combination with R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg\u002Fm2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg\u002Fm2 IV followed by oxaliplatin 100 mg\u002Fm2 IV is given on Day 2 of each cycle.",[91,92],"Drug: HMPL-760","Drug: R-GemOx",{"label":94,"type":95,"description":96,"interventionNames":97},"The control group","PLACEBO_COMPARATOR","Placebo QD at the same dose as HMPL-760 in the experimental group will be given in the control group, and the combination therapy is the same as in the experimental group.",[98,92],"Drug: HMPL-760 Placebo",[100,105,109],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":75},"DRUG","HMPL-760","Patients will receive HMPL-760 once daily (QD) orally.",[87],{"type":101,"name":106,"description":107,"armGroupLabels":108,"otherNames":75},"HMPL-760 Placebo","Patients will receive HMPL-760 placebo once daily (QD) orally.",[94],{"type":101,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"R-GemOx","R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg\u002Fm2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg\u002Fm2 IV followed by oxaliplatin 100 mg\u002Fm2 IV is given on Day 2 of each cycle.",[94,87],[114,115,116],"Rituximab Injection","Gemcitabine Hydrochloride for Injection","Oxaliplatin Injection",[118],{"name":119,"affiliation":120,"role":121},"Weili Zhao","Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","PRINCIPAL_INVESTIGATOR",[123],{"name":124,"role":125,"phone":126,"phoneExt":75,"email":127},"Dongmei Chen, CPL","CONTACT","86-21-20671794","dongmeic@hutch-med.com",[129,148,162,176,187,201,215,229,240,251,265,276,289,303,317,331,342,356,370,380,394,408,422,433,446,457,470,484,494,505,519,533,547,562,573,584,598,611,622,636,650],{"facility":130,"status":131,"city":132,"state":133,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":141,"contacts":142},"Fudan University Shanghai Cancer Center","NOT_YET_RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":137,"coordinates":138},"Point",[139,140],121.45806,31.22222,{"lat":140,"lon":139},[143,147],{"name":144,"role":125,"phone":145,"phoneExt":75,"email":146},"Fangfang Lv","18017312613","Lvff80@163.com",{"name":144,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":149,"status":131,"city":150,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Baoding NO.1 Central Hospital","Baoding",{"type":137,"coordinates":152},[153,154],115.46246,38.87288,{"lat":154,"lon":153},[157,161],{"name":158,"role":125,"phone":159,"phoneExt":75,"email":160},"Haiying Yao","18617789030","haiyingyaobd@163.com",{"name":158,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":163,"status":131,"city":164,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Beijing GoBroad 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University",{"type":137,"coordinates":243},[220,221],{"lat":221,"lon":220},[246,250],{"name":247,"role":125,"phone":248,"phoneExt":75,"email":249},"Hongling Peng","18900766137","Penghongling@aliyun.com",{"name":247,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":252,"status":131,"city":253,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Sichuan Provincial People's Hospital","Chengdu",{"type":137,"coordinates":255},[256,257],104.06667,30.66667,{"lat":257,"lon":256},[260,264],{"name":261,"role":125,"phone":262,"phoneExt":75,"email":263},"Xiaobing Huang","18981838236","hxb_trial@163.com",{"name":261,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":266,"status":131,"city":253,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"West China Hospital of Sichuan University",{"type":137,"coordinates":268},[256,257],{"lat":257,"lon":256},[271,275],{"name":272,"role":125,"phone":273,"phoneExt":75,"email":274},"Liqun Zou","18980601027","Clinical_Zou@163.com",{"name":272,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":277,"status":131,"city":278,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Chongqing University Cancer Hospital","Chongqing",{"type":137,"coordinates":280},[281,282],106.55771,29.56026,{"lat":282,"lon":281},[285,288],{"name":286,"role":125,"phone":75,"phoneExt":75,"email":287},"Yao Liu","liuyao101709@163.com",{"name":286,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":290,"status":131,"city":291,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Quanzhou First Hospital.Fujian","Fujian",{"type":137,"coordinates":293},[294,295],106.12972,28.92651,{"lat":295,"lon":294},[298,302],{"name":299,"role":125,"phone":300,"phoneExt":75,"email":301},"Xiongpeng Zhu","13805998581","xiongpengzhu@163.com",{"name":299,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":304,"status":131,"city":305,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Fujian Medical University Union Hospital","Fuzhou",{"type":137,"coordinates":307},[308,309],119.30611,26.06139,{"lat":309,"lon":308},[312,316],{"name":313,"role":125,"phone":314,"phoneExt":75,"email":315},"Jianzhen Shen","138 0955 2722","doctorsjz@163.com",{"name":313,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":318,"status":131,"city":319,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Sun Yat-sen University Cancer Center","Guangzhou",{"type":137,"coordinates":321},[322,323],113.25,23.11667,{"lat":323,"lon":322},[326,330],{"name":327,"role":125,"phone":328,"phoneExt":75,"email":329},"Zhiming Li","13719189172","lzmsysu@163.com",{"name":327,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":332,"status":131,"city":319,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":333,"geoPoint":335,"contacts":336},"ZhuJiang Hospital of Southern Medical University（The Second Clinical Medical College）",{"type":137,"coordinates":334},[322,323],{"lat":323,"lon":322},[337,341],{"name":338,"role":125,"phone":339,"phoneExt":75,"email":340},"Yuhua Li","13533706656","liyuhua2011gz@163.com",{"name":338,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":343,"status":131,"city":344,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"The Affiliated Hospital of Guizhou Medical University","Guiyang",{"type":137,"coordinates":346},[347,348],106.71667,26.58333,{"lat":348,"lon":347},[351,355],{"name":352,"role":125,"phone":353,"phoneExt":75,"email":354},"Yan Zhang","13914712395","zhangyan1106@njmu.edu.cn",{"name":352,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":357,"status":131,"city":358,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"The First Affiliated Hospital, Zhejiang University","Hangzhou",{"type":137,"coordinates":360},[361,362],120.16142,30.29365,{"lat":362,"lon":361},[365,369],{"name":366,"role":125,"phone":367,"phoneExt":75,"email":368},"Zhen Cai","13857190311","czclinicaltrial@163.com",{"name":366,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":371,"status":131,"city":358,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":372,"geoPoint":374,"contacts":375},"Zhejiang Cancer Hospital",{"type":137,"coordinates":373},[361,362],{"lat":362,"lon":361},[376,379],{"name":377,"role":125,"phone":75,"phoneExt":75,"email":378},"Haiyan Yang","2054451461@qq.com",{"name":377,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":381,"status":131,"city":382,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Harbin Medical University Cancer Hospital","Harbin",{"type":137,"coordinates":384},[385,386],126.65,45.75,{"lat":386,"lon":385},[389,393],{"name":390,"role":125,"phone":391,"phoneExt":75,"email":392},"Qingyuan Zhang","13313612989","sy86298276@163.com",{"name":390,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":395,"status":131,"city":396,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"The Second Affiliated Hospital of Anhui Medical University","Hefei",{"type":137,"coordinates":398},[399,400],117.28083,31.86389,{"lat":400,"lon":399},[403,407],{"name":404,"role":125,"phone":405,"phoneExt":75,"email":406},"Zhimin Zhai","13855147434","zzzm889@163.com",{"name":404,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":409,"status":131,"city":410,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":411,"geoPoint":415,"contacts":416},"Qilu Hospital of Shandong University","Jinan",{"type":137,"coordinates":412},[413,414],116.99722,36.66833,{"lat":414,"lon":413},[417,421],{"name":418,"role":125,"phone":419,"phoneExt":75,"email":420},"Shuqian Xu","18560087013","yoyoshuqian@126.com",{"name":418,"role":121,"phone":75,"phoneExt":75,"email":75},{"facility":423,"status":131,"city":410,"state":75,"zip":75,"country":134,"countryCode":135,"cosmosGeoPoint":424,"geoPoint":426,"contacts":427},"Shandong Cancer Hospital & 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Sign the ICF and be able to follow the requirements of study protocol;\n2. Age ≥18 years;\n3. ECOG performance status score between 0 and 2;\n4. Histopathologically confirmed diagnosis of DLBCL;\n5. The investigator judges that the patient's current condition requires further treatment;\n6. Patients should have at least one bi-dimensionally measurable lesion;\n7. Expected survival is more than 12 weeks;\n\nExclusion Criteria:\n\n1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;\n2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;\n3. Organ insufficiency;\n4. Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);\n5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;\n6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);\n7. The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);\n8. 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