[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510547":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":51,"responsibleParty":65,"collaborators":67,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":49,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":49,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":54,"whyStopped":49,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"National Health Research Institutes, Taiwan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1b\u002FII","EXPERIMENTAL","* Infusional nal-IRI (ONIVYDE, free form) 50\u002F60\u002F70 mg\u002Fm2 over 90 minutes day 1.\n* Infusional Ramucirumab(Cyramza)8 mg\u002Fkg over 60 minutes day 1.\n* oral Trifluridine\u002FTipiracil TAS-102 (LONSURF) 30 mg\u002Fm2\u002Fb.i.d. day 1-5.\n* Every 14 days count as one cycle.",[13,14,15],"Drug: nal-IRI \u002FExperimental","Drug: Ramucirumab \u002FExperimental","Drug: Trifluridine\u002FTipiracil \u002FExperimental",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","nal-IRI \u002FExperimental","infusional 50\u002F60\u002F70 mg\u002Fm2 over 90 minutes day 1, every 14 days.",[9],[23],"ONIVYDE",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Ramucirumab \u002FExperimental","infusional 8mg\u002Fkg over 60 minutes day 1, every 14 days.",[9],[29],"Cyramza",{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Trifluridine\u002FTipiracil \u002FExperimental","oral 30 mg\u002Fm2\u002Fb.i.d. day 1-5, every 14 days.",[9],[35],"LONSURF",[37],{"name":38,"affiliation":5,"role":39},"Nai-Jung Chiang, MD-PhD","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Chien-Ya Hung, BS","CONTACT","+886-3-7206166","35104","951106@nhri.edu.tw",{"name":38,"role":43,"phone":48,"phoneExt":49,"email":50},"+886-9-58925290",null,"njchiang@nhri.edu.tw",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":49,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":49},"Taipei Veterans General Hospital","RECRUITING","Taipei","Taiwan\u002FTaipei","Taiwan","TW",{"type":60,"coordinates":61},"Point",[62,63],121.52639,25.05306,{"lat":63,"lon":62},{"type":66,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[68,71,73,75,77],{"name":69,"class":70},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"name":72,"class":6},"China Medical University Hospital",{"name":74,"class":6},"National Cheng-Kung University Hospital",{"name":76,"class":6},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"name":78,"class":6},"Chang Gung Memorial Hospital","100510547","phase-1-ramucirumab-cyramza-nal-iri-onivyde-and-trifluridinetipiracil-lonsurf-in-second-line-metastatic-gastric-cancer--100510547",false,"NCT05927857","Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine\u002FTipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .","A Phase Ib\u002FII Study of Ramucirumab (Cyramza®), Nal-IRI (ONIVYDE®) and Trifluridine\u002FTipiracil (Lonsurf®) in Second Line Metastatic Gastric Cancer (COOL Study).","Inclusion Criteria:\n\n1. histologically or cytologically confirmed metastatic gastric adenocarcinoma\n2. patients have received only first line of systemic therapy, including recurrence during adjuvant therapy or within 6 months after the completion of adjuvant treatment.\n3. ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1\n4. patients with HER2\u002Fneu-positive tumor must be exposure to Herceptin treatment\n5. at least one measurable disease according to the RECIST version 1.1;\n6. patients are aged 20 to 80 years;\n7. patients have a life expectancy ≥ 3 months;\n8. patients have adequate renal function with defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or Ccr ≥ 40 mL\u002Fmin;\n9. patients with adequate hepatic function as defined by a total bilirubin ≤1.5 times the ULN, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN or 5 times the ULN in the setting of liver metastases.\n10. patients have adequate bone marrow function, defined as an absolute neutrophil count ≥ 1500\u002Fmm3, hemoglobin ≥9 g\u002FdL, and platelet count ≥ 100,000\u002Fmm3 (transfusion or G-CSF support before enrollment is allowed)\n11. patients have International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) (PTT\u002FaPTT) \\\u003C 1.5 x ULN;\n12. patients' urinary protein is ≤1+ on dipstick or routine urinalysis or a 24-hour urine collection for protein must demonstrate \\\u003C1000 mg of protein if urine dipstick or routine analysis is ≥ 2+;\n13. patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study;\n14. female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose of protocol therapy;\n15. the ability to understand and willingness and to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. patient can't take oral drugs;\n2. known hypersensitivity to irinotecan, fluoropyrimidine, or ramucirumab;\n3. receipt of surgery within the past 4 weeks before study enrollment;\n4. ≥ grade 2 diarrhea and ascites\n5. concurrent severe infection with intravenous systemic antibiotics treatment;\n6. patients have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy;\n7. patients have a prior history of GI perforation\u002Ffistula (within 6 months of first dose of protocol therapy) or risk factors for perforation;\n8. patients have:\n\n   * cirrhosis at a level of Child-Pugh B (or worse) or\n   * cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis;\n9. patients have a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy;\n10. patients have undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery\u002Fsubcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. Patients have elective or planned major surgery to be performed during the course of the clinical trial;\n11. patients have uncontrolled or poorly-controlled hypertension (\\>160 mmHg systolic or \\> 100 mmHg diastolic for \\>4 weeks) despite standard medical management;\n12. patients have experienced any grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy;\n13. patients have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \"significant\") during the 3 months prior to first dose of protocol therapy;\n14. patients are receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg\u002Fday) is permitted;\n15. previously received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) or ramucirumab therapy\n16. another previous malignancy diagnosed within the past 5 years except for non melanoma skin cancer or stage I cervical cancer;\n17. pregnant or breast feeding women.","ALL","20 Years","80 Years",{"count":90,"type":91},45,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","Primary Objectives\n\n* In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE®) in combination with Ramucirumab (Cyramza®) and TAS-102 (LONSURF®)\n* In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza®), nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) Secondary Objectives\n* To evaluate disease control rate (DCR)\n* To evaluate progression-free survival (PFS)\n* To evaluate overall survival (OS)\n* To assess the safety profile\n* To study the blood biomarkers",[98,99,100],"Metastatic Gastric Adenocarcinoma","Second Line","Chemotherapy",[102,103,104],"nal-IRI (ONIVYDE)","TAS-102 (LONSURF)","Ramucirumab (Cyramza)","2026-04-06",{"date":107,"type":108},"2026-04-09","ACTUAL",{"date":110,"type":108},"2024-04-01",{"date":112,"type":91},"2028-12-31",{"name":5,"class":6},1]