[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653174":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":48,"overallOfficials":54,"centralContacts":62,"locations":72,"responsibleParty":133,"collaborators":135,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":32,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":170,"whyStopped":32,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"National Health Research Institutes, Taiwan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)","To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of liposomal irinotecan (nal-IRI) in combination with cisplatin in patients with advanced or metastatic solid malignancies.","During cycle one, approximately 28 days",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate (ORR) by RECIST Version 1.1","Objective response rate (ORR) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nEvery 8 weeks from first dose until documented disease progression or death from any cause, whichever occurs first.","up to approximately 5 years",{"measure":19,"description":20,"timeFrame":17},"Progression-Free Survival (PFS)","Progression-free survival (PFS), defined as the time from the first dose to documented disease progression or death from any cause, whichever occurs first.",{"measure":22,"description":23,"timeFrame":24},"Safety Profile","Safety profile assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE Version 5.0.","From initiation of study treatment through 30 days after the end of study treatment.",{"measure":26,"description":27,"timeFrame":17},"Overall survival (OS)","OS will be measured from the start date of study treatment to the date of death.",{"measure":29,"description":30,"timeFrame":31},"Objective Response Rate (ORR)","ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1. Tumor assessments will be performed by CT scan within 28 days prior to registration and every 8 weeks after treatment initiation, or as clinically indicated. Objective responses must be confirmed by a subsequent tumor assessment performed at least 4 weeks after the initial response.","Every 8 weeks from treatment initiation until documented disease progression, withdrawal, death, or end of study participation, up to approximately 5 years.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","The study consists of a dose-escalation phase followed by a dose-expansion phase.","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","To assess the safety and anti-tumor activity of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin in patients with advanced solid malignancies Primary endpoint To find the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"combination of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin","EXPERIMENTAL","Patients receive liposomal irinotecan (nal-IRI) and cisplatin administered intravenously on Days 1 and 15 of each 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.",[47],"Drug: Liposomal Irinotecan Plus Cisplatin",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"DRUG","Liposomal Irinotecan Plus Cisplatin","Liposomal irinotecan and cisplatin are administered intravenously on Days 1 and 15 of each 28-day cycle.",[43],[55,58],{"name":56,"affiliation":5,"role":57},"Hui-Jen Tsai, MD, PhD","STUDY_DIRECTOR",{"name":59,"affiliation":60,"role":61},"Li-Yaun Bai, MD, PhD","China Medical University Hospital","STUDY_CHAIR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":32,"email":67},"Li-Yaun Bai, MD, PhD,","CONTACT","886+975-680928","lybai6@gmail.com",{"name":69,"role":65,"phone":70,"phoneExt":32,"email":71},"Wei-Li Ma, MD, PhD,","886-0972653425","excellent0667@gmail.com",[73,86,95,106,117,125],{"facility":60,"status":32,"city":74,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Taichung","Taiwan","TW",{"type":78,"coordinates":79},"Point",[80,81],120.6839,24.1469,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":32,"phoneExt":32,"email":32},"Li-Yuan Bai, MD,PhD",{"facility":87,"status":32,"city":74,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Taichung Veterans General Hospital",{"type":78,"coordinates":89},[80,81],{"lat":81,"lon":80},[92],{"name":93,"role":65,"phone":32,"phoneExt":32,"email":94},"Huey-En Tzeng, MD,PhD","rollingstone07@gmail.com",{"facility":96,"status":32,"city":97,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"National Cheng Kung University Hospital","Tainan",{"type":78,"coordinates":99},[100,101],120.21333,22.99083,{"lat":101,"lon":100},[104],{"name":105,"role":65,"phone":32,"phoneExt":32,"email":32},"Chun-Hui Lee, M.D.PhD",{"facility":107,"status":32,"city":108,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"MacKay Memorial Hospital","Taipei",{"type":78,"coordinates":110},[111,112],121.52639,25.05306,{"lat":112,"lon":111},[115],{"name":116,"role":65,"phone":32,"phoneExt":32,"email":32},"Johnson Lin, MD",{"facility":118,"status":32,"city":108,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"National Taiwan University Hospital",{"type":78,"coordinates":120},[111,112],{"lat":112,"lon":111},[123],{"name":124,"role":65,"phone":32,"phoneExt":32,"email":32},"Wei-Li Ma, MD",{"facility":126,"status":32,"city":108,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"Taipei Veterans General Hospital",{"type":78,"coordinates":128},[111,112],{"lat":112,"lon":111},[131],{"name":132,"role":65,"phone":32,"phoneExt":32,"email":32},"Chun-Yu Liu, MD,PhD",{"type":134,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[136,137,138,141,143,145,146],{"name":60,"class":6},{"name":118,"class":6},{"name":139,"class":140},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"name":142,"class":6},"Mackay Memorial Hospital",{"name":144,"class":6},"National Cheng-Kung University Hospital",{"name":87,"class":6},{"name":147,"class":6},"Chang Gung Memorial Hospital","100653174","phase-1-a-phase-i-study-of-liposomal-irinotecan-nal-iri-onivyde-plus-cisplatin-in-patients-with-advanced-or-metastatic-solid-malignancies-100653174",false,"NCT07782346","Liposomal Irinotecan Plus Cisplatin in Patients With Advanced or Metastatic Solid Malignancies","Phase I Trial to Evaluate Safety and Efficacy of Combination of Liposomal Irinotecan (Nal-IRI; ONIVYDE®) and Cisplatin in Patients With Advanced or Metastatic Solid Malignancies (ICONIC Study)","ICONIC","Inclusion Criteria:\n\n* 1\\. Patients with age 20-85 years old.\n* 2\\. Cytologically or histologically confirmed solid malignancies which are locally advanced, recurrent or metastatic diseases. The disease cannot be cured by surgical intervention or local therapies.\n* 3\\. The malignancies are refractory to standard systemic therapy or there is no available systemic therapy.\n* 4\\. Followings are the diseases entities which are limited in each part:\n\n  * a. Dose escalation phase (cohort 1): non-small cell lung cancer, small cell lung cancer, gastric cancer, neuroendocrine carcinoma, biliary tract cancer (including intrahepatic cholangiocarcinoma \\[CCA\\], extrahepatic CCA, gallbladder cancer, ampullary cancer), ovarian cancer, esophageal cancer, thymoma or thymic carcinoma.\n  * b. Dose expansion phase (cohort 2): only thymic carcinoma.\n* 5\\. Radiologically measurable disease as defined by RECIST v1.1.\n* 6\\. Baseline ECOG performance status score 0-1.\n* 7\\. Life expectancy of at least 12 weeks.\n* 8\\. Adequate hematologic parameters, and hepatic and renal functions defined as\n\n  * a. Absolute neutrophil count ≥ 1500 \u002FμL (without growth factor support at least 7 days).\n  * b. Platelets ≥ 90000 \u002FμL (evaluated at least 7 days after last platelet transfusion).\n  * c. Hemoglobin ≥ 9 g\u002FdL (evaluated at least 14 days after last RBC transfusion).\n  * d. Total bilirubin ≤ 1.5X ULN.\n  * e. AST\u002FALT ≤ 2.5X ULN (≤ 5X ULN if attributable to liver metastases).\n  * f. serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula \\[CCr={((140-age) x weight \\[kg\\])\u002F(72x serum creatinine \\[mg\u002FdL\\])}x 0.85 (if female)\\] or 24-hour urine collection).\n* 9\\. Normal ECG or ECG without any clinical significant findings.\n* 10\\. Able to understand and sign an informed consent (or have a legal representative who is able to do so).\n* 11\\. Women or men of reproductive potential should agree to use an effective contraceptive method.\n\nExclusion Criteria:\n\n* 1\\. Patients who have major surgery, radiotherapy or other systemic chemotherapy or immunotherapy within 3 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable \u002F evaluable disease.\n* 2\\. Patient with history of severe allergy to liposomal irinotecan (nal-IRI; ONIVYDE®) or cisplatin.\n* 3\\. Significant cardiovascular impairment: (1) history of congestive heart failure greater than New York Heart Association (NYHA) Class II, left ventricular ejection fraction\\\u003C 50%; or (2) unstable angina, myocardial infarction or stroke within 6 months; or (3) uncontrolled cardiac arrhythmia.\n* 4\\. Patients with electrolyte abnormalities that have not been corrected.\n* 5\\. Patients with active metastatic lesions in central nervous system, or need prednisolone ≥ 10 mg\u002Fday to control related symptoms\n* 6\\. Patients with active bacterial, fungal, tuberculosis or human immunodeficiency virus infection\n* 7\\. Patients with positive hepatitis B surface antigen (HBsAg) but not receiving anti-hepatitis B drug. Patients who have positive HBsAg, positive anti-HBc, or positive anti-HCV are eligible if the corresponding HBV-DNA or HCV-RNA are undetectable.\n* 8\\. Subjects who have not recovered adequately from any toxicity from other anti-cancer treatment regimens and\u002For complications from major surgery prior to starting therapy.\n* 9\\. Patients who have peripheral neuropathy \\> grade I of any etiology.\n* 10\\. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, or other condition that in the opinion of the investigator would preclude the subject's participation in the study.\n* 11\\. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma or basal cell carcinoma of skin, or any malignancy which remains disease-free for 3 or more years after curative treatment.\n* 12\\. Females who are breastfeeding or pregnant at screening or baseline.\n* 13\\. Patients with psychiatric illness which would preclude study compliance.\n* 13\\. Patients with psychiatric illness which would preclude study compliance.\n* 14\\. Patients who have received any prior treatment with ONIVYDE® (liposomal irinotecan) or irinotecan-containing regimens","ALL","20 Years","85 Years",{"count":160,"type":161},44,"ESTIMATED","INTERVENTIONAL",[164],"PHASE1","Phase I trial, Multiple centers, open-label, non-randomized single-arm study",[167],"Advanced Solid Malignancies",[169],"advanced solid malignancies","NOT_YET_RECRUITING","2026-08-24",{"date":173,"type":174},"2026-08-26","ACTUAL",{"date":176,"type":161},"2026-10-01",{"date":178,"type":161},"2032-12-31",{"name":5,"class":6},6]