Phase I/II multicenter clinical trial of S-1/CDDP/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer

Phase I/II multicenter clinical trial of S-1/CDDP/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer - Phase I/II clinical trial of S-1/CDDP/Trastuzumab therapy for HER2-positive advanced gastric cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007436

Enrollment

Registered

2012-03-03

Start date

2012-04-01

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

HER2-positive Stage IV advanced gastric cancer

Interventions

TS-1/CDDP/Trasutzumab combination chemotherapy

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, CDDP or Trastuzumab

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Safety - Type and grade of adverse event - Frequency of adverse events Efficacy - Time to treatment failure(TTF) - Progression free survival(PFS), - Overall survival(OS)	—

Countries

Japan

Contacts

Public ContactIkuo Wada

The University of Tokyo Dept. of 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