Pilot study of S-1/Paclitaxel/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer.

Pilot study of S-1/Paclitaxel/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer. - KGCSG1201

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009565

Enrollment

Registered

2012-12-17

Start date

2012-01-01

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

S-1/Paclitaxel/Trastuzumab combination chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven advanced gastric cancer. 2) Positive HER2 status(IHC3+ or IHC2+/FISH+) 3) Age of 20 years or older. 4) Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5) Without previous medication history for advanced gastric cancer. 6) Patient who has more than one measurable or evaluable lesion. 7) Patient who is possible of ingestion. 8) Adequate organ function. *WBC count 3,500-12,000/mm3 *Neutrophils count more than 2,000/mm3 *Platelet count more than 100,000/mm3. *Hemoglobin more than 8.0 g/dl. *Total bilirubin level less than 1.5 mg/dl *AST and ALT less than 100 IU/l *Creatinine clearance more than 60mL/min 9) LVEF more than 50% within 28 days. 10) Electrocardiogram was performed within 28 days. 11) Life expectancy of at least 3 months after registration. 12) Written informed conscent to receive this chemotherapy.

Exclusion criteria

Exclusion criteria: 1)Forbidden case to use S-1, Paclitaxel and Trastuzumab. 2)Patient who want to be pregnant and /or pregnant woman. Intend to make pregnant. 3)Infection or inflammatory case. 4)Active hepatitis type HBs positive. 5)Severe heart disease. 6)Severe complicated case. 7)Watery diarrhea. 8)Bleeding from tumor or ulceration. 9)Multiple bone metastasis. 10)Clinical suspicion or previous history of metastasis to brain or meninges. 11)Complicated other active cancer. 12)Operated within 28 days. 13)Mental disability requiring medical treatment. 14)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Overall survival,Progression-free-survival,Response Rate	—

Countries

Japan

Contacts

Public ContactSumiya Ishigami

Graduate School of Medical Sciences Kagoshima University Department of Digestive Surgery, Breast and Thyroid Surgery

Outcome results

None listed

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