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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.
Full 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).
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Exclusion criteria.
Primary purpose
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Interventional model
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50 participants in 1 patient group
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Central trial contact
Ling Xu, PhD; Yunpeng Liu, PhD
Data sourced from clinicaltrials.gov
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