Finding studies
Finding studies
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Ruihua Xu
CONTACT
Lead
Shanghai Henlius Biotech
Patients with confirmed unresectable metastatic/recurrent colorectal adenocarcinoma who have not received systemic anti-neoplastic therapy for metastatic/recurrent lesions will be included in this study.Approximately 6-12 patients will be enrolled in the Part I (Safety Run-in Period).Approximately 100 patients will be enrolled in the Part II (Phase II study, 50 in the test group and 50 in the control group).Approximately 568 patients will be enrolled in the Part III (Phase III study, 284 in the test group and 284 in the control group). Part II (Phase II study): Approximately 40 study sites in China will participate. Part III (Phase III study): A total of approximately 75 study sites in 3 countries(including China, Japan, Indonesia) will participate. The study consists of a screening period (up to 28 days), a treatment period (3-week cycle, up to 2 years), and a follow-up period (including a safety follow-up period, and a survival follow-up every 12 weeks).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
