A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression

A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression - A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008292

Enrollment

Registered

2012-06-29

Start date

2012-07-26

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

Unresectable advanced or recurrent gastric cancer with HER2 overexpression

Interventions

Irinotecan 150mg/m2 day1 every 2 weeks Trastuzumab 6mg/kg day1 every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Unresectable gastric cancer with HER2 overexpression (HER2 IHC 3+, or IHC 2 and FISH+) after first-line chemotherapy with fluorouracil + cisplatin + trastuzumab 2. Stage IV 3. ECOG performnce status 0-2 4. WBC>=3,000/microl 5. Neutrophil>=1,500/microl 6. Hemoglobin>=8.0g/dl 7. Platelet>=100,000/microl 8. Total bilirubin<=1.5mg/dl 9. AST(GOT)<=100 (<=200 if presence of liver metastasis) 10. ALT(GPT)<=100 (<=200 if presence of liver metastasis) 11. Serum creatinine<=2.0mg/dl 12. Ejection fraction on echo cardiogram>=50%

Exclusion criteria

Exclusion criteria: 1. HER2 IHC- or IHC1+, or IHC2+/FISH- 2. Ejection fraction on echo cardiogram<=50% 3. Discontinuation of trastuzumab in first-line chemotherapy due to adverse reaction of trastuzumab 4. Intestinal paralysis or ileus 5. Uncontrolled diarrhea 6. Massive ascites or pleural effusion 7. Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 8. Uncontrolled diabetes 9. Uncontrolled hypertension 10. Unstable angina pectoris, or a history of myocardial infarction within six months 11. Synchronous cancers 12. Systemic infection requiring treatment 13. Fever above 38 degree Celsius 14. A possibility of pregnancy or during pregnancy, or lactating women 15. Psychosis or psychotic symptoms 16. Continuous systemic administration of steroids (oral or intravenous) 17. Hypersensitivity to ingredients of irinotecan or trastuzumab

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Adverse events, overall survival, response rate	—

Countries

Japan

Contacts

Public ContactOsamu Maedad

Nagoya University Hospital Department of Gastroenterology and Hepatology

maeda-o@med.nagoya-u.ac.jp052-741-2111

Outcome results

None listed

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