Phase ll trial of TS-1 + CDDP + Trastuzumab(SPT)-3 weekly schedule in HER2-positive advanced gastric cancer(HERBIS-1) (OGSG 1101)

Phase 2

• Conditions: Advanced Gastric Cancer

• Registration Number: JPRN-UMIN000005739
• Lead Sponsor: Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Brief Summary

A total of 56 patients were enrolled. In the full analysis set of 53 patients, the confirmed RR was 68% (95% confidence interval (CI)=54-80%), and the disease control rate was 94% (95% CI=84-99%). Median OS, PFS, and TTF were estimated as 16.0, 7.8, and 5.7 months, respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-10
• Results First Posted: 2014-05-04
• Study Completion: 2014-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who are contraindicated to S-1, CDDP, and Trastuzumab. 2. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant. 3. Patients with active infection. 4. Patients have Active hepatitis type B. 5.Serious illness or medical conditions as defined below; a. Patient with a previous history of congestive heart failure b. Hi-risk uncontrolled arrhythmias c. Unstable angina requiring medication d. Patient with a previous history of myocardial infarction e. Severe heart valve disease f. Patient with a previous history of transmural infarct g. Uncontrolled hypertension 6. Serious complication as followings ; a. Interstitial pneumonia b. Pulmonary fibrosis c. Heart failure d. Renal failure e. Hepatic failure f. Uncontrolled diabetes mellitus 7. Patients with resting dyspnea 8. Patients with fresh bleeding from gastric cancer and/or the digestive tract 9. Patients with diarrhea (4 or more times per day or watery diarrhea). 10.Second primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence) 11. Patients who are received systemic continuous administration of flucytosine, phenytoin, or warfarin. 12. Patients who are received systemic administration of corticosteroid. 13. Any patients judged by the investigator to be unfit to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate(RR)

Secondary Outcome Measures

Name	Time	Method
Safety Progression-free survival(PFS) Overall survival(OS) Time to treatment failure(TTF)