NCT06374888

Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

A Single-arm, Open, Multicenter Phase II Clinical Study of Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Convalife (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis

Interventions

Type	Name	Description
DRUG	Neratinib maleate in combination with capecitabine	Neratinib maleate tablets，Tablets, 40mg/ tablet, 180 tablets/bottle, orally, 240mg once daily, sealed, stored not above 25℃

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-09-30
• Completion: 2027-07-30
• First posted: 2024-04-19
• Last updated: 2024-04-19