Neoadjuvant Chemotherapy for HER2-positive Stage IV advanced gastric cancer with S-1/Cisplatin/Trastuzumab

Neoadjuvant Chemotherapy for HER2-positive Stage IV advanced gastric cancer with S-1/Cisplatin/Trastuzumab - Neoadjuvant Chemotherapy for HER2-positive advanced gastric cancer with S-1/Cisplatin/Trastuzumab

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005548

Enrollment

Registered

2011-05-09

Start date

2011-05-01

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

Gastric Cancer

Interventions

Neoadjuvant Chemotherapy with S-1/Cisplatin/Trastuzumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gastric cancer confirmed by histology 2. HER2 positive confirmed by histology (IHC(immunohistochemistry) 3+, or IHC 2+ and FISH (fluorescence in situ hybridization) positive)) 3. Stage IV advanced gastric cancer 4. Tumor lesion able to be measured 5. Performance Status (ECOG) 0-1

Exclusion criteria

Exclusion criteria: 1. Malignant tumor of other organs 2. Severe medical condition 3. Active bleeding from gastrointestinal tract 4. Poor oral intake 5. Contraindication for S-1, Cisplatin or Trastuzumab

Design outcomes

Primary

Measure	Time frame
Safety of neoadjuvant chemotherapy - Type and grade of adverse event - Onset of adverse event - Frequency of adverse events - Duration of adverse event - Rate of adverse events	—

Secondary

Measure	Time frame
Antitumor efficacy Surgical resectability rate Progression-free survival (PFS) Overall survival (OS)	—

Countries

Japan

Contacts

Public ContactIkuo Wada, M.D., Ph.D.

The University of Tokyo Hospital Gastrointestinal Surgery

wadai-sur@h.u-tokyo.ac.jp03-3815-5411

Outcome results

None listed

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