Phase II Study of combination chemotherapy with SPT in patient with HER2(+) advanced gastric cancer

Phase II Study of combination chemotherapy with SPT in patient with HER2(+) advanced gastric cancer - KGCG-01

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011595

Enrollment

Registered

2013-08-28

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(+) advanced gastric cancer

Interventions

TS-1:80mg/m2/day day1-14 CDDP:60mg/m2 day1 Trastuzumab:8mg/kg day1 (from second course 6mg/kg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed unresectable or recurrent gastric adenocarcinoma 2) Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) 3) unresecrable or advanced gastric cancer 4) Patients who have measurable region defined by RECIST version 1.1 within 28 days before enrollment 5) No prior chemotherapy or radiotherapy for gastric cancer 6) Performance status (ECOG scale) 0 or 1 7) Age 20- 8) Patients without the evidence of clear peritoneal metastases 9) Patients able to take orally 10) Adequate baseline organ and marrow function 11) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment 12) Patients should sign a written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with a history of serious drug hypersensitivity 2) Patients who are received administration of flucytosine 3) Patients who are received continuous administration of phenytoin, or warfarin. 4) Patients with active infection 5) Patients with serious complication 6) Patients with diarrhea (4 or more times per day or watery diarrhea) 7) Patients with massive ascites or massive pleural effusion retention. 8) Patients with serious heart disease 9) Uncontrolled hypertension 10) Second primary malignancy 11) Women in pregnancy, at risk of pregnancy, hoping to become pregnant 12) Men who want their partners to become pregnant 13) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival Time to treatment failure Safety	—

Countries

Japan

Contacts

Public ContactHideki Bou

Nippon Medical School Musasikosugi Hospital Digestive Disease Center

bou@nms.ac.jp044-733-5181

Outcome results

None listed

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