This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Beijing cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)
Time frame: From the first dose to the last visit, approximately11 months
Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)
Time frame: From the first dose to the last visit, approximately 11months
Duration of Response (DoR) assessed by Independent Review Committee (IRC)
Time frame: From the first dose to the last visit, approximately 11months
Progression-Free Survival (PFS) assessed by the Investigator
Time frame: From the first dose to the last visit, approximately11 months
Objective Response Rate (ORR) assessed by the Investigator
Time frame: From the first dose to the last visit, approximately 11 months
Duration of Response (DoR) assessed by the Investigator
Time frame: From the first dose to the last visit, approximately 11 months
Overall Survival (OS)
Time frame: From the first dose to the last visit, approximately 11 months
Incidence and severity of Adverse Events (AEs).
Time frame: From the first dose to the last visit, approximately11 months
Anti-SHR-A1811 Antibodies (ADA)
Time frame: From the first dose to the last visit, approximately 11 months
Plasma concentrations of toxin-conjugated antibody of SHR-A1811
Time frame: From the first dose to the last visit, approximately 11 months
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