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Brief Title: Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients
Official Title: Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients:An Open-label, Single-arm, Multicenter Phase I/II Study
Study ID: NCT05426811
Brief Summary: This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.
Detailed Description: This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.This Phase Ib/II study consists of two parts, Phase Ib, an open-ended, single-arm, multi-centre, dose-escalation study evaluating regorafenib, and Phase II, an open-label, multi-centre study evaluating the efficacy and safety of regorafenib in combination with raltitrexed.The primary study endpoint: progression-free survival (PFS).The secondary end endpoints include ORR (overall effectiveness of tumour treatment),DCR (disease control rate),3 month/6 month/9 month/12 month survival OS%,OS (overall survival),incidence and severity of adverse events (AEs), serious adverse events (SAEs).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Yunpeng Liu, PhD
Affiliation: First Hospital of China Medical University
Role: PRINCIPAL_INVESTIGATOR