To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis.
Twenty-eight patients with HER2-positive gastric cancer with brain metastasis were divided into two cohorts: Cohort A: Patients with brain metastases who have not previously received central nervous system radiotherapy, distance from the last systemic treatment junction The beam should be longer than 2 weeks. Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For accepted offices For partially treated lesions, there is clear evidence of progress in imaging examination, and the lesions that have received radiotherapy can be selected as target diseases The kitchen range.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Neratinib maleate tablets,Tablets, 40mg/ tablet, 180 tablets/bottle, orally, 240mg once daily, sealed, stored not above 25℃
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Objective response rates: Proportion of patients whose tumor volume shrinks by 30% and is maintained for more than 4 weeks
Time frame: Throughout the study for approximately 3.5 years
Central nervous response rate
reference to RANO-BM evaluation criteria for neurologic tumor brain metastases
Time frame: Throughout the study for approximately 3.5 years
Objective response rates outside the central nervous system
ORR,Proportion of patients with a 30% reduction in tumor volume that lasts more than 4 weeks
Time frame: Throughout the study for approximately 3.5 years
Disease control rate
It refers to the proportion of cases with complete response, partial response, and stable disease after treatment
Time frame: Throughout the study for approximately 3.5 years
Duration of reaction
It refers to the time between the first evaluation of a tumor as CR or PR and the second evaluation as Progressive Disease (PD) or death from any cause.
Time frame: Throughout the study for approximately 3.5 years
Clinical benefit rate
Refers to the time from the first evaluation of a tumor as CR or PR to the first evaluation as PD or death from any cause.
Time frame: Throughout the study for approximately 3.5 years
overall survival
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Refers to the time between the start of treatment and the patient's death or last follow-up.
Time frame: Throughout the study for approximately 3.5 years