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1、 Journal of Clinical Oncology List of Issues Volume 39,Issue 15_suppl Meeting Abstract|2021 ASCO Annual Meeting IGASTROINTESTINAL CANCERGASTROESOPHAGEAL,PANCREATIC,ANDHEPATOBILIARYToripalimab with chemotherapy as first-linetreatment for advanced biliary tract tumors:Rights&PermissionsOPTIONS&TOOLSEx
2、port CitationTrack CitationAdd To FavoritesADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article ToolsUpdate analytic results of an open-labelphase II clinical study(JS001-ZS-BC001).Wei Li,Yiyi Yu,Xiaojing Xu,Xi Guo,Yueqi Wang,Qian Li,.Show MoreAbstract Disclosurese1
3、6170Background:A phase II clinical study wasconducted to evaluate the safety and efficacy oftoripalimab,a novel PD-1 inhibitor,combined withchemotherapy in patients with advanced biliarytract cancers(aBTCs)(NCT03796429).Thepreliminary results indicated the combinationtreatment is well tolerable and
4、effective.Methods:Treatment naive patients with aBTCs receivedtoripalimab(240mg intravenously every threeweeks)combined with chemotherapy(gemcitabine 1000 mg/m2 d1,d8+S-1 40-60mgCOMPANION ARTICLESNo companion articlesARTICLE CITATIONDOI:10.1200/JCO.2021.39.15_suppl.e16170Journal of Clinical Oncology
5、 39,no.15_supplPublished online May 28,2021.WE RECOMMENDADVERTISEMENTEmployer:Merritt HawkinsApply for this job Employer:Potomac Oncology&HematologyApply for this job Hematology-Oncology OpportunityJust Outside of ChicagoRockford,Illinois N/AA reputable integrated health system seekinga board-certif
6、ied or board-eligiblehematologist-oncologist to join its team.Oncology&Hematology AssociatePositionRockville,Maryland Competitive SalaryThis position offers a competitive base salary,a comprehensive benefits package,exceptional productivity incentives,and apartnership track.Hematology/Oncology-at th
7、e Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractBRAF/MEK Targeting May YieldBenefit in Treating Biliary TractCancerBy Caroline Helwick,The ASCO Post,2019Efficacy,Safety,and CorrelativeBiomarkers of Toripalimab inPreviously Treated Recurre
8、nt orMetastatic NasopharyngealCarcinoma:A Phase II Clinical Trial(POLARIS-02)Feng-Hua Wang et al.,J Clin Oncol,2021BRAF/MEK Targeting May YieldBenefit in Treating Biliary TractCancerBy Caroline Helwick et al.,Hepatobiliary Cancer,2019bid D1-14,Q21d).The treatment continued untilthe disease progress
9、or having intolerable effects.The primary endpoints of the study wereprogression free survival(PFS)and overall survival(OS).The secondary endpoints were objectiveresponse rate(ORR),safety and treatmentbiomarkers.Results:At data cutoff(January 24,2021),fifty aBTC patients were enrolled atShanghai Zho
10、ngshan Hospital.Among thesepatients,56%are males.The median age of thestudy participants was 62 years of age.Themedian follow-up time was 10 months(rangedfrom 4 to 19 months).The primary tumor type wasintrahepatic cholangiocarcinoma(ICC)accountingfor 48%of total cases,followed by gallbladdercancer(G
11、BC)(40.0%),and extrahepaticcholangiocarcinoma(ECC)(12.0%).At the time ofdata collection,48 eligible patients were includedfor data analysis.The median PFS was 7.0 months(95%CI,5.5-9.1 months)and median OS was16.0 months(95%CI,12.1 to unreachable).TheORR was 27.1%and disease control rate was87.5%incl
12、uding 13 partial response(PR)and 29ADVERTISEMENTIntra-arterial hepatic chemotherapycombined with systemic infusion of5-FU in patients with advancedbiliary tract cancersA.Mambrini et al.,J Clin Oncol,2004Treatment of Inoperable and/orMetastatic Biliary Tree CarcinomasWith Single-Agent Gemcitabine or
13、inCombination With Levofolinic Acidand Infusional Fluorouracil:Resultsof a Multicenter Phase II StudyVittorio Gebbia et al.,J Clin Oncol,2016Systemic therapy for advancedcholangiocarcinoma:new options onthe horizonSaleh A.Alqahtani et al.,HepatomaResearch-OAE Publishing,2020Current and future drugco
14、mbination strategies based onprogrammed death-1/programmeddeath-ligand 1 inhibitors in non-small cell lung cancerYing Li Cheng et al.,Chinese MedicalJournal,2021CLINICAL EFFICACY OF CLADRIBINECOMBINED WITH RITUXIMAB INTREATMENT OF RECURRENT ORREFRACTORY MANTLE CELLLYMPHOMAWANG Yawen et al.,Journal o
15、fQingdao University(MedicalSciences),2019Durable ibrutinib responses inrelapsed/refractory marginal zonelymphoma:long-term follow-up andbiomarker analysisstable disease(SD)cases.The most treatmentrelated AEs(TRAE)were leukopenia(92.0%),anemia(86.0%)and rash(52.0%).Grade III/IV non-hematological TRAE
16、s were seen in 12 patients(24.0%),including rash(n=3),infection(n=6),immune-related colitis(n=1),immune-relatedpneumonitis(n=1)and mucositis(n=1).GradeIII/IV hematological TRAEs were seen in 62%patients.6 patients discontinued the study drugdue to TRAE.Serious adverse events(SAE)wereseen in 8 patien
17、ts and 2 patients died of biliaryobstruction complicated with infection.Forty-ninepatients were included in biomarker analysis.Themost mutated genes were TP53(51%),KRAS(20%),CDKN2A(18%)and SMAD4(16%).Patientswith activated PI3K signaling pathway hadsignificantly shorter PFS(P=0.026).Tumormutational
18、burden(TMB)could not serve as apredictor for the efficacy of immunotherapycombined with chemotherapy.Conclusions:Theclinical study of toripalimab combined withchemotherapy continued to show tolerance andefficacy in patients with aBTCs.Gene mutationAriela Noy et al.,Blood Advances,2020Randomized cont
19、rolled trial oficotinib concurrent with thoracicradiotherapy for treating advancednon-small cell lung cancer(NSCLC)Wang Jianfang et al.,Chinese Journalof Radiological Medicine andProtection,2017Powered byprofiling by NGS suggested mutated PI3K pathwaymight assocate with shorter PFS.Clinical trialinf
20、ormation:NCT03796429.2021 by American Society of Clinical OncologyResearch Sponsor:Shanghai Committee of Science and Technology,ChinaQUICK LINKSContentNewest Articles Archive Meeting AbstractsJournal InformationAbout Editorial Roster Contact Us PermissionsResourcesAuthors Reviewers Subscribers Insti
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