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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltitrexed Plus Cetuximab | Experimental | Raltitrexed Plus Cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltitrexed | Drug | Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time from the beginning of first-line treatment until the disease progresses. | Progression Free Survival 1. | 24 months |
| The time from the beginning of maintenance treatment until the disease progresses. | Progression Free Survival 2. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 24 months | |
| Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0 | evaluate the safety of patient medication | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangjun Zhu | Contact | +8613905199123 | zhulj98@foxmail.com | |
| Sheng Li | Contact | +8613770768636 | lihsh198@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liangjun Zhu | Jiangsu Cancer Institute & Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C068874 | raltitrexed |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Cetuximab | Drug | Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w. |
|
| Quality of life score | Based on QLQ-C30 in EORTC, evaluate the quality of life of patients | 24 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |