The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Approximately 110 participants will be assigned to SHR-1210 + capecitabine + oxaliplatin combination therapy (Cohort 1), or SHR-1210 + apatinib combination therapy (Cohort 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: Up to approximately 6 months.
Progression-free Survival (PFS) Per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Up to 24 months.
Duration of Response (DOR) Per RECIST 1.1
For participants who demonstrate CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), DOR is defined as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 based on assessments by blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Up to 24 months.
Disease Control Rate (DCR) Per RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Time frame: Up to 24 months.
Number of Subjects With Treatment-related Adverse Events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time frame: Up to 24 months.
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375 mg administered as continuous oral once daily (QD) of each 3-week cycle.