Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion (HERBIS-1B) (OGSG 1202)

Phase 2

• Conditions: Advanced Gastric Cancer

• Registration Number: JPRN-UMIN000007941
• Lead Sponsor: Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Brief Summary

Fifteen patients were enrolled. The median overall survival was 14.4 months. The 1- and 3-year overall survival rates were 66.7 % and 26.7 %, respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-14
• Study Completion: 2018-03-16
• Results First Posted: 2019-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

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. Patient 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