This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
588
HRS-4642 + AG
HRS-4642 placebo + AG
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
PFS as assessed by BICR per RECIST 1.1
Time frame: up to 2 years
OS
Time frame: up to 3 years
ORR,as assessed by BICR per RECIST v1.1
Time frame: up to 2 years
DCR as assessed by BICR per RECIST v1.1
Time frame: up to 2 years
DoR as assessed by BICR per RECIST v1.1
Time frame: up to 2 years
PFS as assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
ORRas assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
DCR as assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
DoR as assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v5.0.
Time frame: Twice a month,up to 2 years
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