This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
Tianjin Provincial Tumor Hospital
Tianjin, China
RECRUITINGIncidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
Time frame: Up to approximately 2 years
Pathological complete response (pCR) rates
pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes
Time frame: Up to approximately 2 years
Major pathological response(MPR) rates
MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes
Time frame: Up to approximately 2 years
Tumor regression grade(TRG)
Time frame: Up to approximately 2 years
R0 resection rate
Time frame: Up to approximately 2 years
Tumor descending stage rate
Proportion of subjects whose tumor TNM stage decreased from baseline before surgery
Time frame: Up to approximately 2 years
ORR
Time frame: Up to approximately 2 years
EFS
Time frame: Up to approximately 2 years
OS
Time frame: Up to approximately 2 years
PK
Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points
Han Liang, MD
CONTACT
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Oral,Specified dose on specified days
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
Time frame: Up to approximately 2 years
ADA
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: Up to approximately 2 years