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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,ANDHEPATOBILIARYGemox chemotherapy in combination withanti-PD1 antibody toripalimab and lenvatinibas first-line treatment for advancedRi

2、ghts&PermissionsOPTIONS&TOOLSExport CitationTrack CitationAdd To FavoritesADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article Toolsintrahepatic cholangiocarcinoma:A phase 2clinical trial.Zhou Jian,Jia Fan,Guo-Ming Shi,Xiao-Yong Huang,Dong Wu,Guo-HuanYang,.Show More

3、Abstract Disclosures4094Background:The outcome of advancedintrahepatic cholangiocarcinoma(ICC)remainspoor with current gemcitabine-basedchemotherapy.This study is to evaluate the safetyand efficacy of anti-PD1 agent toripalimab,lenvatinib in combination with oxaliplatin andgemcitabine(Gemox)chemothe

4、rapy.Methods:Locally advanced or metastatic ICC patients(pts)were given 240 mg toripalimab Q3W viaintravenous(IV)infusion,8 mg lenvatinib QDorally,and 1g/m gemcitabine on Day 1 and Day 8,COMPANION ARTICLESNo companion articlesARTICLE CITATIONDOI:10.1200/JCO.2021.39.15_suppl.4094Journal of Clinical O

5、ncology 39,no.15_suppl(May 20,2021)4094-4094.Published 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 healt

6、h system seekinga board-certified 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 t

7、rack.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractGemOx(Gemcitabine+Oxaliplatin)versus Gem(Gemcitabine)in nonresectable pancreaticadenocarcinoma:final results of theGERCOR/GISCAD Intergroup PhaseIIIC.Louvet et

8、al.,J Clin Oncol,2004Phase II study of gemcitabine,capecitabine and cisplatin in patientswith advanced pancreatic cancerH.M.Chang et al.,J Clin Oncol,2004Best Supportive Care Compared WithChemotherapy for Unresectable GallBladder Cancer:A RandomizedControlled StudyAtul Sharma et al.,J Clin Oncol,201

9、0and 85 mg/m oxaliplatin Q3W by IV for 6 cycles.The primary outcome was objective response rate(ORR),which was evaluated according to RECISTv1.1.Secondary outcomes included safety,progression-free survival(PFS)and overall survival(OS).Treatment would be terminated byconfirmed disease progression,una

10、cceptabletoxicity,or voluntary withdrawal.Whole exomesequencing was performed on available tumortissues and PD-L1 expression was determined byimmunohistochemistry staining.Results:FromMay 2019 to Oct 2019,30 pathologically-confirmedadvanced ICC pts with a mean age of 56.5(range,25-73)years,including

11、 11 women(37%),wereenrolled at Zhongshan Hospital,Fudan University(one pt withdrawn).At the end of last follow-up(February 1,2021),the ORR was 80%(24/30;95%CI:61.4%-92.3%),and disease control rate(DCR)was 93.3%(28/30;95%CI:77.9%-99.2%).Medianfollow-up was 16.6 months.One pt achievedcomplete response

12、(CR).Three pts with locallyadvanced disease were down-staged and thenunderwent resection.They remained disease-freeADVERTISEMENTRandomised trial of capecitabineplus oxaliplatin(CapOx)versuscapecitabine plus gemcitabine(CapGem)versus gemcitabine plusoxaliplatin(GemOx)in advancedpancreatic cancerV.Hei

13、nemann et al.,J Clin Oncol,2004Chemotherapy with gemcitabine andoxaliplatin in 13 malignant pleuralmesothelioma(MPM):A monocenterexperienceJ.-M.Brechot et al.,J Clin Oncol,2004No added benefit with fixed-dosegemcitabine or gemcitabine plusoxaliplatin in pancreatic cancerHealioAddition of oxaliplatin

14、 to folinic acid-modulated fluorouracil extendedsurvival in pancreatic cancerHealioNew First-Line Treatment Leads toImproved Survival in GastrointestinalCancersBy staff,US Pharmacist,2020Safety,Antitumor Activity,andPharmacokinetics of Toripalimab,aProgrammed Cell Death 1 Inhibitor,in Patients With

15、Advanced NonSmall Cell Lung Cancer:A Phase 1TrialZhijie Wang et al.,JAMA NetworkOpen,2020Nab-Paclitaxel and Gemcitabine asFirst-line Treatment of Advanced orsurvival at the end of last follow-up.23 ptsexperienced disease progression and 12 pts(including one pt withdrawn)have died.Themedian PFS was 1

16、0.0 months and median durationof response(DOR)was 9.8 months.The medianOS have not been reached.12-months OS rate was73.3%(95%CI:57.5%-89.2%).No grade 5 adverseevent(AE)was observed in present study.Grade 3or 4 neutropenia and thrombocytopenia observedin 3(10%)and 1(3.3%)patient,respectively.Non-hem

17、atological toxic effects were jaundice(10%),rash(6.7%),proteinuria(6.7%),increased ASTlevel(3.3%),vomiting(3.3%),uppergastrointestinal hemorrhage(3.3%),sepsis(3.3%),gastrointestinal fistula(3.3%),adrenocorticalinsufficiency(3.3%),interstitial pneumonia(3.3%),and hyponatremia(3.3%).High ORR wassignif

18、icantly associated with positive PD-L1expression(p=0.048)and DNA damage repair(DDR)-related mutations(p=0.022)in tumorsamples.Conclusions:Gemox chemotherapy incombination with Anti-PD1 antibody Toripalimaband Lenvatinib provided remarkable efficacy withMetastatic Cholangiocarcinoma:APhase 2 Clinical

19、 TrialVaibhav Sahai et al.,JAMA Oncology,2018Powered byreasonable tolerability in advanced ICC patients.These findings warrant further validation in alarge randomized clinical trial.Clinical trialinformation:NCT03951597.2021 by American Society of Clinical OncologyResearch Sponsor:NoneQUICK LINKSCon

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