Study design and participants
Tumors, UMIN000018968
TUMORS, DISEASE PROGRESSION, COLORECTAL ADENOCARCINOMA
This REGOCC-12 trial (UMIN registry identifier: UMIN000018968) is a multicentre, single-arm, open-label, Phase II exploratory study conducted at 31 institutions in Japan. Ethical approval of the study protocol was granted by Osaka University Research Ethics Review Committee. The trial was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. All patients provided written informed consent before enrolment.The key inclusion criteria were age ≥ 20 years, unresectable or recurrent colorectal adenocarcinoma, and disease progression during standard chemotherapy or within 3 months after the last administration of standard chemotherapy. Standard chemotherapy involved fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-epidermal growth factor receptor (anti-EGFR; only in patients with wild type [WT] RAS). Patients previously treated with trifluridine/tipiracil (TFTD) were not included. Eligible patients also had one or more measurable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) guideline