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Please use this identifier to cite or link to this item:
http://ir.nhri.org.tw/handle/3990099045/13796
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| Title: | INTEGRATE IIb: A randomised phase III open label study of regorafenib plus nivolumab vs standard chemotherapy in refractory advanced gastro-oesophageal cancer (AGOC) |
| Authors: | Pavlakis, N;Shitara, K;Sjoquist, K;Martin, AJ;Jaworski, A;Yip, S;Oh, DY;Moehler, M;Chen, LT;Bekaii-Saab, T;Simes, J;Goldstein, D |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no established standard treatment following failure of first- and second-line chemotherapy. Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases, and has shown activity in this setting. Single agent regorafenib prolonged progression free survival (PFS) versus placebo across all regions/subgroups in the INTEGRATE randomised phase II trial. Current options in refractory AOGC involves sequencing through chemotherapy with the latest active agent approved being trifluridine/tipiracil, TAS-102. Promising activity in refractory AOGC has been seen with the combination of regorafenib & nivolumab. INTEGRATE IIb – will compare the effectiveness of the combination of regorafenib & nivolumab in pre-treated patients with AGOC to current standard chemotherapy. Trial design: Randomised phase III, open label study with 2:1 randomisation (RegoNivo: standard chemotherapy) and stratification by: 1. Geographic region (Asia vs. Rest of World) 2. Prior VEGF inhibitors (Yes vs No) 3. Prior immunotherapy (Yes vs No) RegoNivo arm will receive 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle with intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol. The control arm will receive the investigator’s choice of the following chemotherapy; a taxane (paclitaxel or docetaxel), irinotecan or oral trifluridine/tipiracil (TAS102). Primary endpoint: OS. Secondary endpoints: PFS, response rate, quality of life, toxicity, exploratory correlative biomarkers |
| Date: | 2021-09 |
| Relation: | Annals of Oncology. 2021 Sep;32(Suppl. 5):S1074. |
| Link to: | http://dx.doi.org/10.1016/j.annonc.2021.08.1547 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000700527702451 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
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| ISI000700527702451.pdf | | 75Kb | Adobe PDF | 169 | View/Open |
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