Gastric cancer Gastric cancer, early relapse, irinotecan, ramucirumab
Conditions
Interventions
Irinotecan 150 mg/m^2 day 1 div
Ramucirumab 8 mg/kg day 1 div
Continued for 2-week courses until the subject becomes refractory.
Sponsors
YAMAGUCHI Toshifumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A histopathological diagnosis of adenocarcinoma. 2) Patients who are on DS adjuvant chemotherapy after the confirmation of pathological stage III (including ypIII) after radical gastrectomy*1. 3) Early recurrence postsurgery: during DS adjuvant chemotherapy*2 or a recurrence within*3 six months after completing therapy*4. 4) Age of >20 years. 5) Performance status 0 or 1 6) Lesions that can be evaluated by imaging according to RECIST 1.1 guidelines or nonmeasurable lesions. 7) Laboratory results with the following values within 14 days prior to clinical study registration. Of all values within this 14day period, the most recent will be used for registration. Using the day of registration as the reference point, laboratory results 2 weeks prior to registration can be used as long as the results reflect samples collected on the same day as the registration day. Absolute neutrophil count (ANC): =>1,500/mm3 Hemoglobin: =>9.0 g/dL Platelet count: =>100000/mm3 AST, ALT: =40ml/min (estimated creatinine clearance rate using the Cockcroft-Gault formula or creatinine concentration measured after 24-hour urine collection) Urinary protein: =2 g/24 hours after 24-hour urine collection, or urinary protein/creatinine ratio 6 months after the initiation of the final course, because of patient circumstances or the facility, and the patient was diagnosed with recurrence within 4 weeks after the 6-month time point, then the patient was included in the study. *4 After the completion of adjuvant therapy: the end date of adjuvant therapy is defined as 6 weeks after the start date of the final course.
Exclusion criteria
Exclusion criteria: 1.Active multiple primary cancers (synchronous and heterogeneous multiple primary cancers within a 5-year disease-free interval). However, localized treatment resulting in a cure of pathological lesions such as carcinoma in situ or equivalent to intramucosal cancer would not be considered as active multiple primary cancers. 2.Symptomatic interstitial pneumonia or pulmonary fibrosis is observed. 3.An infection requiring systemic treatment; however, even if HBsAg positive, if the infection is being controlled by nucleoside/nucleotide analogs and serum is confirmed as HBV-DNA negative, then the subject is eligible for registration. 4.Body temperature of 38C at the time of registration. 5.Pregnant, lactating women, those who may be currently pregnant, or are unwilling to use contraceptives. 6.Diagnosed with or manifestations of mental illness demonstrated such that the subject has difficulty in participating in the clinical study. 7.Continued systemic steroid administration. 8.Presence of a serious complication. 9.Anticoagulants are being administered for thromboembolism treatment. 10.Uncontrolled hypertension (for example, even with standard oral agents, blood pressure exceeds 150/90 mm Hg). 11.Uncontrolled diarrhea affecting daily activities despite adequate treatment. 12.Evidence of active bleeding (a history of grade 3 or 4 bleeding within 3 months of receiving the first adjuvant treatment). 13.No symptoms consistent with evidence of metastasis to the central nervous system (brain, spinal cord, and meninges). 14.Blood transfusion treament within 2 weeks of registration. 15.Presence of more than moderate pleural effusion with ascites accumulation. 16.Is in the process of enrolling in another interventional clinical study at the time of registration for this clinical study. 17.Currently on medication with ataznavir sulfate, for which co-administration with IRI is contraindicated. 18.Other situations in which the clinical study physician determines that the subject is an unsuitable candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival (PFS), time to treatment failure (TTF), response rate (RR), disease control rate (DCR), safety (rate of occurence of grade 3/4 adverse events), relative dose intensity (RDI) | — |
Contacts
Public ContactToshifumi YAMAGUCHI
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed