JPRN-jRCTs051180196CompletedPhase 2
A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer (Herceptin with SOX for Gastric Cancer) - HIGHSOX study
Takahari Daisuke0 sites75 target enrollmentStarted: March 26, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
Results from this phase 2 study suggest that trastuzumab with SOX is well tolerated and has promising efficacy, offering one possibility of new treatment option as a first-line chemo therapy for patients with HER2-positive advanced gastric cancer.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 75age old (—)
- Sex
- All
Inclusion Criteria
- •1) Histologically proven advanced or recurrent adenocarcinoma
- •2) No prior therapy except for adjuvant chemotherapy of S-1 finished more than 6 months before
- •3) With measurable lesions by RECIST version 1.1
- •4) HER2 positive (IHC 3+ or IHC 2 + and ISH +)
- •5) Age 20 - 75
- •6) ECOG PS 0 or 1
- •7) No symptomatic cerebral lesions
- •8) Adequate organ functions
- •9) LVEF (Left Ventricular Ejection Fraction) > 50 %
- •10) No abnormal findings in ECG
- •11) Possible for oral intake
- •12) With an expected survival longer than 3 months
- •13) Wth written Informed consent
Exclusion Criteria
- •1) Could not administrate S-1, oxaliplatin, and trastuzumab
- •2) Pregnant and/or nursing women or men who wish to have children in future
- •3) With active infectious disease
- •4) HBs antigen positive
- •5) With a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease, and uncontrollable hypertension
- •6) With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure, uncontrollable diabetes mellitus
- •7) With dyspnea at rest
- •8) With active bleeding from gastric cancer / ulcer
- •9) With severe diarrhea
- •10) With severe sensory neuropathy
- •11) With active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years
- •12) Under meditation of flucytosine, phenytoin,or warfarin
- •13) Under continuous meditation of steroids
- •14) Judged to be unfit to participate in this study by investigator
Investigators
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