EN-hance

JRCT ID: jRCTs031200336

Registered date:01/02/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 08/04/2021
• Target sample size: 64
• Study type: Interventional

Intervention(s)

Three-drug combination (APR+PALO+DEX) group
Two-drug combination (PALO+DEX) group

Outcome(s)

• Primary Outcome: Complete response rate
• Secondary Outcome: Complete response rate, complete control rate, total control rate, TTF, OS, safety evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Aoyama Toru
• Secondary Sponsor: DAIICHI SANKYO Co.,Ltd.