INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG)

LL Lam; N Pavlakis; K Shitara; KM Sjoquist; AJ Martin; S Yip; YK Kang; YJ Bang; LT Chen; M Moehler; T Bekaii-Saab; T Alcindor; CJ O’Callaghan; NC Tebbutt; W Hague; H Chan; SY Rha; KW Lee; V Gebski; A Jaworski; J Zalcberg; T Price; J Simes; D Goldstein

Journal article

INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG)

LL Lam, N Pavlakis, K Shitara, KM Sjoquist, AJ Martin, S Yip, YK Kang, YJ Bang, LT Chen, M Moehler, T Bekaii-Saab, T Alcindor, CJ O’Callaghan, NC Tebbutt, W Hague, H Chan, SY Rha, KW Lee, V Gebski, A Jaworski Show all

BMC Cancer | Published : 2023

DOI: 10.1186/s12885-023-10642-7

Abstract

Background: Advanced gastro-oesophageal cancer (AGOC) carries a poor prognosis. No standard of care treatment options are available after first and second-line therapies. Regorafenib is an oral multi-targeted tyrosine kinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases. Regorafenib 160 mg daily prolonged progression free survival compared to placebo (INTEGRATE, phase 2). Regorafenib 80 mg daily in combination with nivolumab 3 mg/kg showed promising objective response rates (REGONIVO). Methods/design: INTEGRATE II (INTEGRATE IIa and IIb) platform comprises two international phase III randomised controlled trials (RCT) with 2:1 randomisation in favor of expe..

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