Unresectable and/or recurrent gastric cancer
Conditions
Interventions
Group A TS-1 80 mg/m2, day 1-21, CDDP 60 mg/m2, day 8. The above doses are repeated every 35 days. Trastuzumab 8 mg/kg, day 1 (6 mg/kg after the second administration) The above dose is repeated e
Sponsors
Juntendo University School of Medicine Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with radically unresectable or recurrent gastric cancer 2) Subjects whose HER2 status in primary or metastatic lesions has already been proven 3) Subjects with measurable lesions according to RECIST v1.1 within 28 days before enrollment 4) Subjects without pretreatment (radiation therapy, chemotherapy, hormone therapy, etc.) for gastric cancer (Subjects with an elapsed time longer than 24 weeks after completion of the most recent preoperative chemotherapy or postoperative adjuvant chemotherapy can be enrolled.) 5) Subjects at least 20 years but not more than 75 years of age at the time of enrollment 6) Performance Status:Subjects with an ECOG PS score of 0 or 1 7) Subjects capable of oral ingestion 8) Subjects proven to have well-maintained functions of the following main organs (bone marrow, heart, lungs, kidneys, etc.) by examinations within 14 days before enrollment (Examinations on the same day two weeks before enrollment are allowed.) White blood cell count: more than 3,500/mm3, less than 12,000/mm3 Neutrophil count : more than 2,000/mm3 Hemoglobin: more than 9.0 g/dL Platelet count: more than 100,000/mm3 Total bilirubin: less than 1.5 mg/dL AST, ALT: less than 100 IU/L Creatinine: less than 1.2 mg/dL Creatinine clearance: more than 60 ml/min 9) Subjects with LVEF values exceeding 50% on cardiac function examinations such as echocardiography within 28 days before enrollment 10) Subjects without clinically important abnormalities on 12-lead electrocardiography within 28 days before enrollment 11) Subjects with an expected survival time of at least three months after the date of enrollment 12) Subjects providing written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1)Subjects with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.) 2)Subjects with a previous history of serious drug hypersensitivity 3)Subjects requiring continuous use of flucytosine, phenytoin, and/or warfarin potassium 4)Subjects being treated with pyrimidine fluoride antineoplastic agents other than TS-1(including any combination therapy) 5)Subjects with infectious diseases associated with a fever of 38.0 degrees C or higher 6)Subjects shown to be HBs antigen positive 7)Subjects with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, cardiac failure, bone-marrow suppression, and so on) 8)Subjects with diarrhea (more than four times daily or watery stool) 9)Subjects with accumulation of pleural and ascitic fluids requiring paracentesis for symptom relief 10)Subjects with the following cardiac diseases or conditions Previous history of congestive cardiac failure Angina pectoris requiring drug treatment Obvious transmural myocardial infarction on electrocardiograph Clinically-evident cardiac valvular disease Poorly-controlled hypertension (systolic BP>180mmHg and/or diastolic BP>100mmHg) High-risk uncontrolled arrhythmias A previous history of myocardial infarction Ischemic cardiac disease requiring treatment 11)Women of child-bearing potential (intention), pregnant or lactating women 12)Men desiring to have children 13)Subjects with a previous history of serious psychiatric diseases or being treated for such diseases and judged to be ineligible for participating in the study 14)Subjects judged by the investigator(s) to be inappropriate study participants for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Outcome results
None listed