EN-hance

A Multicenter Randomized Open-Label Phase 2 Study Investigating Optimal Antiemetic Therapy for Subjects with Unresectable Recurrent Gastric Cancer Undergoing Trastuzumab deruxtecan

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200336

Enrollment

Registered

2021-02-01

Start date

2021-04-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 =30 mL/min as calculated using the Cockcroft-Gault equation 6. Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Complete response rate	—

Secondary

Measure	Time frame
Complete response rate, complete control rate, total control rate, TTF, OS, safety evaluation	—

Contacts

Public ContactYasushi Rino

Yokohama City University Hospital

rino@med.yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026