NCT04241731

A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer

A Multicenter Phase II Clinical Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Maintenance treatment can extend patient survival and improve patient quality of life. Bevacizumab alone or capecitabine combined with bevacizumab as a maintenance treatment have been widely used in clinical practice. In contrast, there are little datas of cetuximab as a maintenance treatment. The purpose of this study is to evaluate efficacy and safety of Raltitrexed plus Cetuximab as the maintenance treatment, and to provide a new choice for RAS wild-type colorectal cancer patients after advanced first-line chemotherapy.

Detailed description

Maintenance treatment can prevent the toxicity and give patients a relative buffer period to alleviate the impact of follow-up treatment on the body without reducing efficacy. Bevacizumab alone or capecitabine combined with bevacizumab as a maintenance treatment have been widely used in clinical practice. There are little datas of cetuximab as a maintenance treatment ,some studies show that Cetuximab is effective in maintenance treatment, and some studies have reported adverse effects of Capecitabine combined with Cetuximab.So it is worthwhile to explore more suitable maintenance treatment options. Raltitrexed, a TS enzyme inhibitor, is an effective chemotherapy drug for colorectal cancer. We plan to evaluate efficacy and safety of Raltitrexed plus Cetuximab in maintenance treatment. Maybe we can provide a new choice for RAS wild-type colorectal cancer patients after advanced first-line chemotherapy.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Raltitrexed	Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.
DRUG	Cetuximab	Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.

Timeline

• Start date: 2019-11-28
• Primary completion: 2021-11-28
• Completion: 2021-11-28
• First posted: 2020-01-27
• Last updated: 2021-08-30

Locations

1 site across 1 country: China