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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.
Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China
RECRUITINGThe time from the beginning of first-line treatment until the disease progresses.
Progression Free Survival 1.
Time frame: 24 months
The time from the beginning of maintenance treatment until the disease progresses.
Progression Free Survival 2.
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0
evaluate the safety of patient medication
Time frame: 24 months
Quality of life score
Based on QLQ-C30 in EORTC, evaluate the quality of life of patients
Time frame: 24 months
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