JPRN-UMIN000017182Completed未知
Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer - Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer
agoya City University Hospital, Department of gastroenterology0 sites25 target enrollmentStarted: April 20, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
A total of 25 patients from six centers were enrolled. In the 25 patients evaluable for analysis, the 1-year survival rate was 70.8% [90% confidence interval (CI) = 55.5-86.1%], whereas the median OS, PFS, and ORR were 17.8 months, 7.6 months, and 75.0%, respectively. Major grade 3/4 adverse events included anorexia (20%), anemia (16%), peripheral sensory neuropathy (16%), and diarrhea (15%). SOX100 combined with trastuzumab was effective with a favorable safety profile in patients with HER2-positive AGC.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 80years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1.patient who has drug allergy as past history 2. case of administration contraindication 3. patient who needs flucytosine, phenytoin, and Warfarin 4. patient who has active infectious disease with fever over 38 degree 5. patient who has severe complication (intestinal palsy, ileus, interstitial pneumonia, DM, renal failure, liver failure under bad control) 6. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 7. patient who has metastatic brain tumor with symptoms 8. watery diarrhea 9. severe ascites and/or pleural effusion 10. patient who has active double cancer 11. patient who want to be pregnant and /or pregnant woman 12. man who want to have a child 13. patient who was not judged to be suitable for this clinical trial
Investigators
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