biostudies-literatureUnknown13(1)Chen X<h4>Introduction</h4>Neoadjuvant chemotherapy (NAC) has been demonstrated effective in several tumours, but its benefit has not yet been elucidated in colorectal cancer, especially locally advanced colorectal cancer (LACRC).<h4>Methods and analysis</h4>This is a single-arm, open-label, prospective phase II exploratory clinical trial. Patients with LACRC will receive four cycles of NAC with 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI), followed by operation and then adjuvant chemotherapy with capecitabine and oxaliplatin for two to five cycles or single-agent capecitabine for five cycles, or observation. The primary endpoint is the rate of tumour regression grade (TRG) 0-2 in the resected tumour tissue, which is evaluated by experienced pathologists according to the Ryan R TRG graBMJ opene062659https://www.ebi.ac.uk/biostudies/studies/S-EPMC9890744biostudies-literaturePathological response and safety of FOLFOXIRI for neoadjuvant treatment of high-risk relapsed locally advanced colon cancer: study protocol for a single-arm, open-label phase II trial.PMC9890744Leng WChen XZhou YCao PQiu MWang ZYu YMeng WfalsePathological response and safety of FOLFOXIRI for neoadjuvant treatment of high-risk relapsed locally advanced colon cancer: study protocol for a single-arm, open-label phase II trial.<h4>Introduction</h4>Neoadjuvant chemotherapy (NAC) has been demonstrated effective in several tumours, but its benefit has not yet been elucidated in colorectal cancer, especially locally advanced colorectal cancer (LACRC).<h4>Methods and analysis</h4>This is a single-arm, open-label, prospective phase II exploratory clinical trial. Patients with LACRC will receive four cycles of NAC with 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI), followed by operation and then adjuvant chemotherapy with capecitabine and oxaliplatin for two to five cycles or single-agent capecitabine for five cycles, or observation. The primary endpoint is the rate of tumour regression grade (TRG) 0-2 in the resected tumour tissue, which is evaluated by experienced pathologists according to the Ryan R TRG gra2023-01-01T00:00:00Z2023 Jan2026-05-29T01:10:27.346Z2024-11-15T20:02:34.562ZS-EPMC98907443672057010.1136/bmjopen-2022-062659