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Spots Global Cancer Trial Database for Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients

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Trial Identification

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

Study Description

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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Yunpeng Liu, PhD

Affiliation: First Hospital of China Medical University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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