gastric or gastroesophageal cancer
Conditions
Interventions
Irinotecan alone IRI 150 mg/m2, day 1 q2w
Ramucirumab plus irinotecan RAM 8 mg/kg day1, q2w IRI 150 mg/m2, day1, q2w
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy. 2)Documented objective radiographic or clinical disease progression after a ramucirumab-containing chemotherapy. 3)No previous history of IRI administration. 4)Neither tolerates nor responds to treatment with fluoropyrimidines, platinum, or taxanes. 5)Has lesions that can be evaluated on CT or MRI images. 6)Age at enrollment 20 years old <=. 7)ECOG performance status (PS) of 0 or 1 at study entry. 8)Oral intake is possible. 9)Adequate organ function, defined as no severe impairment of bone marrow, heart, lungs, liver or kidneys, and laboratory values at the start of treatment that meet the following criteria. 10)Life expectancy of at least 3 months. 11)Written informed consent obtained prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1)History of another malignancy 2)Previous systemic chemotherapy with an angiogenesis inhibitor, except ramucirumab. 3)History of serious adverse events after treatment with RAM. 4)Uncontrolled arterial hypertension. 5)Uncontrollable diarrhea that interferes with everyday activities even if receiving adequate treatment. 6)Undergoing anticoagulant therapy for the treatment of thromboembolism. 7)Local or systemic active infection that requires treatment. 8)Serious illness or medical condition(s) 9)History of severe allergy or hypersensitivity to any drugs. 10)Transfusion treatment within 2 weeks prior to enrollment. 11)Moderate or large ascites or pleural effusion. 12)Continuous systemic steroid treatment. 13)Evidence of a psychological disorder that is judged to make it difficult to ensure the continuous use of the study drug. 14)Symptomatic evidence of known central nervous system metastases. 15)Daily treatment with atazanavir sulfate, which is incompatible with IRI. 16)Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study. 17)17) The patient registered other clinical studies in parallel 18)Any condition that suggests that the patient is, in the investigator's opinion, not an appropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS); time to treatment failure (TTF); response rate (RR); disease control rate (DCR); and adverse events (AEs) | — |
Countries
Japan
Contacts
Public ContactDaisuke Sakai
Osaka University Graduate School of Medicine Department of Frontier Science for Cancer and Chemotherapy
Outcome results
None listed