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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05426811
Study type Interventional
Source China Medical University, China
Contact Yunpeng Liu, PhD
Phone 86-24-83282312
Email cmu_trial@163.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date July 1, 2022
Completion date December 30, 2025

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