NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200336

Registered date:01/02/2021

EN-hance

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedgastric cancer
Date of first enrollment01/02/2021
Target sample size64
Countries of recruitment
Study typeInterventional
Intervention(s)Three-drug combination (APR+PALO+DEX) group Two-drug combination (PALO+DEX) group

Outcome(s)

Primary OutcomeComplete response rate
Secondary OutcomeComplete response rate, complete control rate, total control rate, TTF, OS, safety evaluation

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Yasushi Rino
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail rino@med.yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital
Scientific contact
Name Toru Aoyama
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail aoyamat@yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital