Advanced gastric cancer patients with HER2 over expression CTCs whose primary lesion is HER2 negative or of unknown HER2 status
Conditions
Interventions
XP(capecitabine+cisplatin)+trastuzumab
Sponsors
The Cancer Institute Hospital of JFCR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent. (2) 20 years old or more when received informed consent. (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 2. (4) Life expectancy estimated 3 months, and more. (5) Histological confirmation of gastric cancer. (6) Confirmed HER2 positive CTCs. (7) Advanced gastric cancer patients with HER2 positive CTCs whose primary lesion is HER2 negative or unmeasurableHER2 status. With measurable lesion. (8) Patients with metastatic gastric cancer who had received no previous therapy. Patients with recurrent colorectal cancer Who have not been administered any therapy to the recurrent site. (relapse morth than 6 months after adj-therapy) (9) Vital organ functions (listed below) are preserved within 14 days prior to entry. 1.Neutrophils>=1500/mm3 2. Platelets>=100,000/mm3 3. Hemoglobin>=9.0 g/dl 4. Total bilirubin>=upper limit of normal (ULN)*1.5 5. AST and ALT <= upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 6. Serum creatinine <= upper limit of normal (ULN) *1.5 7. Creatinine clearance >= 60 ml/min
Exclusion criteria
Exclusion criteria: (1) Baseline left ventricular ejection fraction (LVEF) => 50% measured by echocardiography or MUGA scan (2)CNS metastases or brain cancer confirmed by imaging. (3) Patients who meet any of the following criteria will be excluded from the study. 1. Patient with a previous history of congestive heart failure 2. Unstable angina requiring med 3.Confirmed transmural myocardial infarction by ECG 4.Uncontrolled hypertension(SAP>180mmHg or DBP>=100mmHg) 5. Severe heart valve disease 6. Hi-risk uncontrolled arrhythmias (4) History of active double cancer within 5 year. (without healed cutaneous basal cell carcinomas and carcinoma in situ of the cervix, or digestive system cancer verified cure by endoscopic mucosal resection) (5) Severe pulmonary disease (Interstitial pneumonitis or pulmonary fibrosis) (6) History of the organ transplantation to need an immunosuppressive drug (7) Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR: overall response rate Progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety PFS: progression free survival OS: overall survival Prediction of effects based on the number of CTCs and XP+T therapy Prediction of effects based on markers on CTCs and XP+T therapy | — |
Countries
Japan
Contacts
Public ContactSatoshi Matsusaka
The Cancer Institute Hospital of JFCR Gastroenterology
Outcome results
None listed