Spots Global Cancer Trial Database for Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer
Official Title: Phase Ib/II Study of Regorafenib and XELOX Combination as 2nd Line Treatment in Metastatic Colorectal Cancer Patients
Study ID: NCT04008511
Conditions
Study Description
Brief Summary: This is an interventional, randomized open-label, parallel-group, multicenter, dose escalation phase Ib/II study, to investigate the combination of Regorafenib and XELOX as 2nd line treatment in mCRC patients.
Detailed Description: This is a phase Ib/II trial, comprising Phase Ib and Phase II two parts. Phase Ib study is an open-label, single-arm, multicenter, dose escalation study of Regorafenib plus XELOX. In Phase Ib, max 15 patients(pts) could be enrolled based on the modified toxicity probability interval (mTPI) design. Phase II study is a randomized, open-label, parallel-group, multicenter study comparing Regorafenib + XELOX to XELOX alone. In phase II trial, a total of 39 patients will be recruited and randomized 2:1 into two groups, where 26 patients under Regorafenib + XELOX, and 13 patients under XELOX alone.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Hospital of China Medical University, Shenyang, Liaoning, China
Contact Details
Name: Yunpeng Liu, M.D.,Ph.D.
Affiliation: First Hospital of China Medical University
Role: PRINCIPAL_INVESTIGATOR
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