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