{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["13(1)"],"submitter":["Lee CK"],"pubmed_abstract":["In this multi-center phase II trial, we evaluated the efficacy and safety of a quadruplet regimen (pembrolizumab, trastuzumab, and doublet chemotherapy) as first-line therapy for unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC) (NCT02901301). The primary endpoints were recommended phase 2 dose (RP2D) for phase Ib and objective response rate (ORR) for phase II. The secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, time to response and safety. Without dose-limiting or unexpected toxicities, the starting dose in the phase Ib trial was selected as RP2D. In 43 patients, the primary endpoint was achieved: the objective response rate was 76.7% (95% confidence interval [CI]: 61"],"journal":["Nature communications"],"pagination":["6002"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9556512"],"repository":["biostudies-literature"],"pubmed_title":["A single arm phase Ib/II trial of first-line pembrolizumab, trastuzumab and chemotherapy for advanced HER2-positive gastric cancer."],"pmcid":["PMC9556512"],"pubmed_authors":["Zang DY","Lee SK","Kwon WS","Kim H","Rha SY","Kim HS","Chung HC","Che J","Shin SJ","Bae WK","Park S","Lee CK","Nam CM","Koo DH","Kang B","Jeung HC","Jung M"],"additional_accession":[]},"is_claimable":false,"name":"A single arm phase Ib/II trial of first-line pembrolizumab, trastuzumab and chemotherapy for advanced HER2-positive gastric cancer.","description":"In this multi-center phase II trial, we evaluated the efficacy and safety of a quadruplet regimen (pembrolizumab, trastuzumab, and doublet chemotherapy) as first-line therapy for unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC) (NCT02901301). The primary endpoints were recommended phase 2 dose (RP2D) for phase Ib and objective response rate (ORR) for phase II. The secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, time to response and safety. Without dose-limiting or unexpected toxicities, the starting dose in the phase Ib trial was selected as RP2D. In 43 patients, the primary endpoint was achieved: the objective response rate was 76.7% (95% confidence interval [CI]: 61","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Oct","modification":"2026-05-27T20:39:30.955Z","creation":"2025-04-21T14:18:41.457Z"},"accession":"S-EPMC9556512","cross_references":{"pubmed":["36224176"],"doi":["10.1038/s41467-022-33267-z"]}}