NCT05160896

SALIRI Based Regimen as First-line Treatment for Advanced Metastatic Colorectal Cancer

Raltitrexed Combined With Irinotecan (SALIRI) Based Regimen as First-line Treatment for Advanced Metastatic Colorectal Cancer (mCRC) : an Open-label, Multi-center, and Prospective Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective is to investigate the efficacy and safety of raltitrexed combined with Irinotecan (SALIRI) based regimen as first-line treatment for advanced metastatic colorectal cancer(mCRC).

Detailed description

A number of previous studies show that raltitrexed combined with oxaliplatin/irinotecan as first-line treatment for advanced metastatic colorectal cancer(mCRC) is safe and effective. Chinese registered clinical studies show that raltitrexed combined with oxaliplatin has better safety and overall clinical efficacy than 5-FU combined with oxaliplatin in the treatment of mCRC. However, there is no study data on raltitrexed plus irinotecan (SALIRI) combined with targeted drugs as first-line treatment for mCRC in Chinese patients. This an open-label, multi-center, and prospective phase Ⅱ study enroled mCRC patients treated with first-line raltitrexed plus Irinotecan (SALIRI) based chemotherapy. Plan to to enroll 90 patients. The primary outcome is Overall Response Rate(ORR). The secondary Outcomes are Progression Free Survival (PFS)，Overall Survival (OS)，disease control rate (DCR)，the occurrence of adverse reactions(AEs)，and Quality of Life \[WHO-QOL\].

Conditions

• Advanced Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Raltitrexed	Raltitrexed 2 mg/m² iv, 15min. day 1
DRUG	Irinotecan	Irinotecan 180 mg/m² iv, 30 - 90 min. day 1
DRUG	Bevacizumab	Bevacizumab 5 mg/kg, iv, day 1
DRUG	Cetuximab	cetuximab 500 mg/ m² , iv, day 1

Timeline

• Start date: 2021-11-12
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-12-16
• Last updated: 2023-06-08

Locations

1 site across 1 country: China