This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
200 mg on Day 1 of each 3-week cycle as an IV infusion
320mg as continuous oral once daily on every 21 days
1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of XELOX chemotherapy regimen
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, China
Objective Response Rate (ORR)
Objective response rate assessed at 18 weeks after enrollment,that is about 6 cycles of treatment
Time frame: [ Time Frame: Up to approximately 2 years ]
Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR
The time from the beginning of treatment to the progression or death of the patient
Time frame: [ Time Frame: Up to approximately 2 years ]
Overall Survival (OS)
The time from the beginning of treatment to the death of the patient
Time frame: [ Time Frame: Up to approximately 2 years ]
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130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of XELOX chemotherapy regimen and as part of SOX chemotherapy regimen
80 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): \<1.25 m\^2 BSA =40 mg, 1.25 to \<1.5 m\^2 BSA=50 mg, ≥1.5 m\^2 BSA=60 mg. Administered as part of SOX and TS chemotherapy regimen