Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study)

Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study) - GCSPH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005876

Enrollment

Registered

2011-07-01

Start date

2011-07-01

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 HER2 positive gastric cancer

Interventions

Chemotherapy with S-1(80mg/m2/day 14days), Cisplatin(20mg/m2/day day1,8), Trastuzumab(1st-8mg/kg 2nd-6mg/kg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gastric cancer confirmed by histology 2. Patients with unresectable or recurrent gastric cancer 3. HER2 positive confirmed by histology (IHC(immunohistochemistry) 3+, or IHC 2+ and FISH (fluorescence in situ hybridization) positive)) 4. Tumor lesion able to be measured 5. No prior radiotherapy, chemotherapy or hormone therapy 6. Performance Status (ECOG) 0-1 7. Age of 20 to 75 8. Patients with no peritoneal metastasis, intestinal obstruction and no acites 9. Sufficient oral intake 10. Adequate organ functions: WBC >=3500/mm3 and <=12000/mm3, neutrophils >=2000/mm3, platelets >=100,000/mm3, hemoglobin >=9.0g/dL, total bilirubin <=1.5mg/dL, AST(GOT)/ALT(GPT) within twice the normal upper limits creatinin within the normal limits creatinine clearance >=60mL/min. 11. Normal ECG and LVEF>=50% 12. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. patient who has drug allergy as past history 2. patient who needs flucytosine, phenytoin, and Warfarin 3. patient who has active infectious disease with fever over 38 degree 4. patient who has severe complication (interstitial pneumonia, DM, renal failure, liver failure under bad control) 5. watery diarrhea 6. Pleural effusion and acites 7. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 8.Uncontrolable hypertention 9. patient who has active double cancer 10. patient who want to be pregnant and /or pregnant woman 11. man who want to have a child 12. patient who was judged to be unsuitable for this clinical trial

Design outcomes

Primary

Measure	Time frame
Antitumor efficacy	—

Secondary

Measure	Time frame
Progression-free survival (PFS) Overall survival (OS) Antitumor efficacy Adverse events	—

Countries

Japan

Contacts

Public ContactYoshinori Kikuchi

Toho University School of Medicine Department of Internal Medicine

y-kikuchi@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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