A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT04241731|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Raltitrexed Drug: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Clinical Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer|
|Actual Study Start Date :||November 28, 2019|
|Estimated Primary Completion Date :||November 28, 2021|
|Estimated Study Completion Date :||November 28, 2021|
Experimental: Raltitrexed Plus Cetuximab
Raltitrexed Plus Cetuximab
Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.
Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.
- The time from the beginning of first-line treatment until the disease progresses. [ Time Frame: 24 months ]Progression Free Survival 1.
- The time from the beginning of maintenance treatment until the disease progresses. [ Time Frame: 24 months ]Progression Free Survival 2.
- Overall survival (OS) [ Time Frame: 24 months ]
- Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0 [ Time Frame: 24 months ]evaluate the safety of patient medication
- Quality of life score [ Time Frame: 24 months ]Based on QLQ-C30 in EORTC, evaluate the quality of life of patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241731
|Contact: Liangjun Zhufirstname.lastname@example.org|
|Contact: Sheng Liemail@example.com|
|Study Chair:||Liangjun Zhu||Jiangsu Cancer Institute & Hospital|