An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer.
- Conditions
- gastric or gastroesophageal cancer
- Registration Number
- JPRN-UMIN000023065
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 402
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival (OS)
- Secondary Outcome Measures
Name Time Method progression-free survival (PFS); time to treatment failure (TTF); response rate (RR); disease control rate (DCR); and adverse events (AEs)