Spots Global Cancer Trial Database for Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
Official Title: A Randomized, Open-label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
Study ID: NCT04296019
Conditions
Interventions
Study Description
Brief Summary: This study was a randomized, controled, multicenter, phase II clinical study evaluating the efficacy and safety of fruquintinib as a maintenance therapy following first-line treatment for metastatic colorectal cancer. This study will include the patients with confirmed unresectable metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer who achieved stable disease (SD) or partial response (PR) or complete response (CR) via palliative first-line treatment. It's expected to include 110 patients and they will be randomly stratified at 2:1 into fruquintinib group and observation group based on whether bevacizumab is used and the primary tumor site, using the Interactive Network Response System (IWRS). The random No. corresponds to the respective patient. The enrollment time is expected to be 18 months, followed up for 24 months.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Contact Details
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