NCT05426811

Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients

Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients：An Open-label, Single-arm, Multicenter Phase I/II Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Regorafenib
• Raltitrexed
• Colorectal Neoplasms
• Third-line Treatment

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib:120mg/d，Po，qd,d1-d21，Every 4 weeks
DRUG	Raltitrexed	Raltitrexed:3mg/㎡，ivgtt，d1，Every 3 weeks

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-07-01
• Completion: 2025-12-30
• First posted: 2022-06-22
• Last updated: 2022-06-29