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A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Summary
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Official title: A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2023-05-25
Completion Date
2028-07-15
Last Updated
2024-03-15
Healthy Volunteers
No
Conditions
Interventions
Sintilimab
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
IBI310&Sintilimab
In ARM Phase Ib\&III Experimental group,IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
Radical surgery
In ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China