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Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

StatusActive, Not Recruiting
PhasePhase 3
Started2024-03-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 17, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-16
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 120→confirmed 130
Study sitesdetails revised at 1 of 1 site
2024-03-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02→confirmed 2024-03-01
Study sites0→1
2024-01-15
Study Identification, Study Status, Study Design, Arms and Interventions v1
Enrollment target96→120
InterventionsSHR-A1811 (Drug), TAS-102 (Drug)→SHR-A1811 (Drug), TAS-102, Regorafenib , Fruquintinib (Drug)
Study title+20 characters
Injection of SHR-A1811 Versus TAS-102Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan
2024-01-08
Original filing
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.
Trial Details
NCT Number NCT06199973
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Advanced Colorectal Cancer
Enrollment 130 participants
Start Date 2024-03-01
Primary Completion 2026-04 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-17