This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The trial consists of two groups. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2 will receive KN026+KN046+XELOX.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGpCR rate
Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
Time frame: up to 2 years
Event-free survival (EFS)
Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
Time frame: from enrollment until firstly confirmed and recorded disease progression or death,assessed up to 3 years
Disease-free survival (DFS)
Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
Time frame: from the start of surgery to disease recurrence or death (for any reason),assessed up to 3 years
overall survival (OS)
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.