FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3122820680> ?p ?o ?g. }

• W3122820680 endingPage "TPS357" @default.
• W3122820680 startingPage "TPS357" @default.
• W3122820680 abstract "TPS357 Background: Hepatocellular carcinoma (HCC) is the 4th leading cause of cancer related death worldwide. HCC typically develops in patients with cirrhosis and has a 5-year survival estimate of 20%. Only patients with early stage disease may be eligible for a curative approach using local treatment and/or transplant. The majority of patient present with advanced HCC and will require systemic treatment for disease control. Several systemic therapies are FDA-approved for the treatment of HCC; however, they are only approved for patients with Child-Pugh class A cirrhosis. There are limited data and no approved second-line therapy for HCC with more advanced cirrhosis, including Child-Pugh class B, which represents a significant proportion of patients. The aim of this trial is to determine the safety and efficacy of cabozantinib, a multi-kinase inhibitor, in patients with HCC with Child-Pugh class B cirrhosis. Methods: This investigator-initiated, phase I/II study is enrolling 32 patients with advanced HCC, Child-Pugh B7 or B8, who have previously received first-line systemic treatment. Patients receive cabozantinib at one of 3 dose levels (20 mg, 40 mg, and 60 mg) with a starting dose level of 40 mg to evaluate the safety profile and obtain the recommended phase 2 dose (RP2D). The primary endpoint is assessment of dose-limiting toxicity with a null hypothesis greater than 35%. Secondary endpoints include ORR per RECIST v1.1, PFS, OS, and PK profile. Exploratory endpoints include whole exome/RNAseq analysis (including MET, VEGF, AXL, and immune signature), spatial profiling of immune markers by multiplex immunofluorescence, and specimen banking (tissue, blood and imaging). The trial design is based on the Time-To-Event modification of the Continual Reassessment Method (TiTE-CRM), which allows for continued monitoring of toxicity as a function of a dose-over-time, and is flexible with regard to the number of patients treated at a certain dose. The trial is open at University of Michigan as lead and coordinating site, and due to open at 3 additional high-volume centers. Clinical trial information: 04497038." @default.
• W3122820680 created "2021-02-01" @default.
• W3122820680 creator A5008409227 @default.
• W3122820680 creator A5017798169 @default.
• W3122820680 creator A5036507987 @default.
• W3122820680 creator A5040663276 @default.
• W3122820680 creator A5076767039 @default.
• W3122820680 creator A5077771845 @default.
• W3122820680 creator A5088300643 @default.
• W3122820680 date "2021-01-20" @default.
• W3122820680 modified "2023-09-23" @default.
• W3122820680 title "A phase I/II trial to evaluate cabozantinib in patients with advanced hepatocellular carcinoma with Child-Pugh class B cirrhosis after first-line therapy." @default.
• W3122820680 doi "https://doi.org/10.1200/jco.2021.39.3_suppl.tps357" @default.
• W3122820680 hasPublicationYear "2021" @default.
• W3122820680 type Work @default.
• W3122820680 sameAs 3122820680 @default.
• W3122820680 citedByCount "0" @default.
• W3122820680 crossrefType "journal-article" @default.
• W3122820680 hasAuthorship W3122820680A5008409227 @default.
• W3122820680 hasAuthorship W3122820680A5017798169 @default.
• W3122820680 hasAuthorship W3122820680A5036507987 @default.
• W3122820680 hasAuthorship W3122820680A5040663276 @default.
• W3122820680 hasAuthorship W3122820680A5076767039 @default.
• W3122820680 hasAuthorship W3122820680A5077771845 @default.
• W3122820680 hasAuthorship W3122820680A5088300643 @default.
• W3122820680 hasConcept C121608353 @default.
• W3122820680 hasConcept C126322002 @default.
• W3122820680 hasConcept C143998085 @default.
• W3122820680 hasConcept C203092338 @default.
• W3122820680 hasConcept C2777214474 @default.
• W3122820680 hasConcept C2778019345 @default.
• W3122820680 hasConcept C2778695046 @default.
• W3122820680 hasConcept C2781064419 @default.
• W3122820680 hasConcept C535046627 @default.
• W3122820680 hasConcept C71924100 @default.
• W3122820680 hasConcept C90924648 @default.
• W3122820680 hasConceptScore W3122820680C121608353 @default.
• W3122820680 hasConceptScore W3122820680C126322002 @default.
• W3122820680 hasConceptScore W3122820680C143998085 @default.
• W3122820680 hasConceptScore W3122820680C203092338 @default.
• W3122820680 hasConceptScore W3122820680C2777214474 @default.
• W3122820680 hasConceptScore W3122820680C2778019345 @default.
• W3122820680 hasConceptScore W3122820680C2778695046 @default.
• W3122820680 hasConceptScore W3122820680C2781064419 @default.
• W3122820680 hasConceptScore W3122820680C535046627 @default.
• W3122820680 hasConceptScore W3122820680C71924100 @default.
• W3122820680 hasConceptScore W3122820680C90924648 @default.
• W3122820680 hasFunder F4320312140 @default.
• W3122820680 hasIssue "3_suppl" @default.
• W3122820680 hasLocation W31228206801 @default.
• W3122820680 hasOpenAccess W3122820680 @default.
• W3122820680 hasPrimaryLocation W31228206801 @default.
• W3122820680 hasRelatedWork W1879835999 @default.
• W3122820680 hasRelatedWork W2036867087 @default.
• W3122820680 hasRelatedWork W2062847965 @default.
• W3122820680 hasRelatedWork W2809889937 @default.
• W3122820680 hasRelatedWork W2906326983 @default.
• W3122820680 hasRelatedWork W2977772831 @default.
• W3122820680 hasRelatedWork W3021210585 @default.
• W3122820680 hasRelatedWork W3204411353 @default.
• W3122820680 hasRelatedWork W4229062662 @default.
• W3122820680 hasRelatedWork W9288866 @default.
• W3122820680 hasVolume "39" @default.
• W3122820680 isParatext "false" @default.
• W3122820680 isRetracted "false" @default.
• W3122820680 magId "3122820680" @default.
• W3122820680 workType "article" @default.