A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced Unresectable or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
610
AK104 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward, AK104 will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
Placebo (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward,Placebo will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Overall Survival (os)
OS in the ITT population.
Time frame: Up to 2 years
ORR
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
Time frame: Up to 2 years
DCR
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
Time frame: Up to 2 years
DoR
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
TTR
TTR is defined as the time to response base on RECIST v1.1
Time frame: Up to 2 years
PFS
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1
Time frame: Up to 2 years
AE
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
Time frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
Observed concentrations of AK104
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration
Time frame: From first dose of AK104 through the last dose of AK104, about average of 9 months.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Time frame: From first dose of AK104 through 30 days after last dose of AK104