This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ AC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.
Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.
Oxaliplatin 130 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.
Capecitabine 1000 mg/m\^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.
Beijing Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
Changzhou First People's Hospital
Changzhou, China
The First Affiliated Hospital of College of Medicine, Zhejiang University; Medical Oncology
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Anhui Province Cancer Hospital
Hefei, China
Liaoning cancer Hospital & Institute
Shenyang, China
Tianjin Cancer Hospital
Tianjin, China
Hubei Cancer Hospital
Wuhan, China
...and 1 more locations
Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population
Time frame: Up to approximately 20 months
Duration of Response (DOR) in Responders of the FAS Population
Time frame: The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months
Progression-free Survival (PFS) in the FAS Population
Time frame: The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months
Overall Survival (OS) in the FAS Population
Time frame: The time from initiation of study treatment to death due to any cause up to approximately 20 months
Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the FAS Population
Time frame: Up to approximately 20 months
Change from Baseline in EORTC QLQ-C30 in the FAS Population
Time frame: Up to approximately 20 months
Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire in Gastric Cancer (EORTC QLQ-STO22) in the FAS Population
Time frame: Up to approximately 20 months
Change from Baseline in EORTC QLQ-STO22 in the FAS Population
Time frame: Up to approximately 20 months
ORR in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression
Time frame: Up to approximately 20 months
Duration of Response (DOR) in Responders of a Subgroup Population With PD-L1 and/or TIGIT Positive Expression
Time frame: The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months
Progression-free Survival (PFS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression
Time frame: The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months
Overall Survival (OS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression
Time frame: The time from initiation of study treatment to death due to any cause up to approximately 20 months
Number of Participants With Adverse Events
Time frame: Up to approximately 20 months
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