This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
506
Peking University Cancer Hospital & Institute
Beijing, China
RECRUITINGProgression-free survival (PFS) assessed by blinded independent central review (BICR)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Time frame: Up to 2 years
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to 2 years
Progression-free survival (PFS) assessed by investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Time frame: Up to 2 years
Objective Response Rate (ORR)
ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria
Time frame: Up to 2 years
Duration of Response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).
Time frame: Up to 2 years
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iv, q3w