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.
Age ≥18 years old
Histologically or cytologically confirmed advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases (clear imaging evidence of metastasis)
Tumor tissue was HER2 positive Her2-positive is defined as immunohistochemical (IHC) 3+ or IHC 2+ and in situhybridization (ISH) positive
Presence of a measurable lesion according to RECIST 1.1: presence of at least one non-radiation-treated lesion with a diameter ≥10 mm (lymph node lesion with a diameter ≥15 mm) that can be accurately measured at baseline on CT or MRI and can be repeatedly measured. If study participants only have lesions after radiotherapy, and the lesions have been clearly identified as radiological progression and can be measured, they can be selected as target lesions. The brain lesion must have a measurable target lesion, but it is not required to have a measurable targetlesion outside the brain
Participants who have received chemotherapy or radiation therapy (including study drugs) within 2 weeks prior to study participation, or who have not fully recovered from adverse events (excluding hair loss) due to taking drugs for more than 4 weeks
Patients who have previously received anti-HER2 small-molecule TKI therapy progression
More than two seizures in the first 4 weeks of enrollment
Participants currently receiving any other study drug
Single group
Neratinib maleate in combination with capecitabine
DrugNeratinib 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
Central nervous response rate
reference to RANO-BM evaluation criteria for neurologic tumor brain metastases
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
Disease control rate
It refers to the proportion of cases with complete response, partial response, and stable disease after treatment
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.
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