EN-hance
- Conditions
- gastric cancer
- Registration Number
- JPRN-jRCTs031200336
- Lead Sponsor
- Aoyama Toru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
1. Patients of age >= 20 years at the time of obtaining consent
2. Patients who have been diagnosed HER2 positive (IHC 3+ or IHC 2+ and, ISH +) gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma
3. Patients scheduled to have T-DXd after tertiary treatment for gastric adenocarcinoma or GEJ adenocarcinoma
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
5. Maintaining adequate organ functions and met the criteria listed below within 28 days before enrollment
5.1. ALT <=126 U/L (if liver metastases are present, <=210 U/L)
5.2. AST <=126 U/L (if liver metastases are present, <=150 U/L)
5.3. Total bilirubin <=2.5 mg/dl (if liver metastases are present, <=4.5 mg/dl)
5.4. Creatinine clearance >=30 mL/min as calculated using the Cockcroft-Gault equation
6. Written informed consent
1. Patients with complication or history of interstitial lung disease
2. Patients with active multiple cancers with a disease-free period of less than 5 years
3. Patients with history of hypersensitivity to NK1 receptor antagonist, 5-HT3 receptor antagonist, DEX, Trastuzumab, T-DXd
4. Patients with vomiting or nausea as CTCAE Grade 2 or higher.
5. Patients with brain metastases with clinical symptoms.
6. Patients with gastric pyloric stenosis or intestinal obstruction
7. Patients with ascites or pleural effusion that require paracentesis
8. Pregnant or lactating women, or patient who do not agree to contraception during the study period
9. Patients participating in other interventional studies
10. History of treatment with T-DXd
11. Inadequate oral administration
12. Patient receiving Pimozide
13. Other patients who are judged inappropriate to participate in the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate
- Secondary Outcome Measures
Name Time Method Complete response rate, complete control rate, total control rate, TTF, OS, safety evaluation