[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"second-line\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:second-line":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640153","phase-2-a-clinical-study-of-liposomal-irinotecan-for-second-line-therapy-in-metastatic-colorectal-cancer-100640153",false,"NCT07585279","A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer","Liposomal Irinotecan-based Regimen Versus Irinotecan-based Regimen in Second-Line Treatment for Metastatic Colorectal Cancer (IRIS-02): A Randomized, Controlled Phase II\u002FⅢ Study","Inclusion Criteria:\n\n1. Aged ≥ 18 years old and ≤ 75 years old.\n2. Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;\n3. Patients must have at least one measurable lesion according to RECIST 1.1 criteria.\n4. Had received first-line treatment based on oxaliplatin.\n5. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;\n6. Expected survival time ≥3 months.\n7. Adequate organ function, meeting the following laboratory test standards:\n\n1\\) Bone marrow function: Neutrophils≥1.5×109\u002FL, Platelets≥100×109\u002FL, Hemoglobin≥90 g\u002FL, White blood cells ≥3.0×109\u002FL; 2) Liver function:Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase≤2.5×upper limit of normal (ULN), when there is liver metastasis, ≤ 5×ULN; Total bilirubin≤1.5×ULN; 3) Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 60 ml\u002Fmin, Urine protein≤2+; 4) Coagulation function: Activated partial thromboplastin time and International Normalized Ratio ≤1.5 × ULN; 5) Thyroid function: Thyroid stimulating hormone≤ULN; If abnormal, additional tests for FT3 and FT4 should be conducted and their levels should be normal; 6) Albumin≥3 g\u002FdL; 8. Pregnant women of childbearing age with negative pregnancy test and non-lactating, participants with reproductive capacity must receive effective contraceptive measures; 9. Patients and\u002For legal representative must have the ability to understand and voluntarily sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a history of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell carcinoma of the skin.\n2. Prior treatment with irinotecan or liposomal irinotecan-based chemotherapy, or prior treatment with immune checkpoint inhibitors (including but not limited to PD-1 inhibitors, PD-L1 inhibitors, and CTLA-4 inhibitors).\n3. Patients with left-sided colorectal cancer, RAS\u002FBRAF wild-type, who did not receive cetuximab in first-line therapy.\n4. Patients with known mismatch repair dysfunction or microsatellite instability ;\n5. Patients with a large amount of pleural effusion or ascites that require drug intervention treatment;\n6. Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, who show persistent signs\u002Fsymptoms without improvement despite appropriate antimicrobial therapy.\n7. Known active HIV infection; untreated active HBV or HCV infection.\n8. Patients with uncontrolled systemic diseases, including: cardiac disease of NYHA Class II or above; uncontrolled hypertension (defined as systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg despite standard antihypertensive therapy) or a history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus; etc.\n9. Patients with active autoimmune diseases, or with a history of autoimmune disease within 2 years prior to enrollment that still requires systemic therapy. Exceptions include participants with well-controlled type 1 diabetes, hypothyroidism controlled with hormone replacement alone, skin disorders not requiring systemic treatment, or those in whom recurrence is not anticipated in the absence of external triggers.\n10. Patients with primary immunodeficiency diseases or with a history;\n11. Patients who have received immunosuppressant treatment within 14 days before enrollment or require daily systemic steroid treatment (such as \\> 20 mg\u002Fday prednisone or equivalent drugs), except those treated with nasal, inhalation or other routes of local glucocorticoid therapy;\n12. Patients with severe gastrointestinal diseases;\n13. History of abdominal surgery, thoracic surgery, or intestinal resection within 28 days prior to enrollment.\n14. Had interstitial lung disease or non-infectious pneumonia requiring glucocorticoid treatment;\n15. Known hypersensitivity or intolerance to the investigational drugs or their excipients.\n16. History of pulmonary hemorrhage or hemoptysis of grade 2 or higher (defined as at least 2.5 mL of bright red blood) within 1 month prior to enrollment.\n17. History of arterial thromboembolism, severe bleeding (excluding surgical bleeding), or active thromboembolic or severe bleeding events within 6 months prior to enrollment.\n18. Had symptomatic central nervous system metastasis;\n19. Had strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1;\n20. Receipt of intravenous antitumor therapy within 28 days, or oral antitumor medication within 14 days, prior to the first dose of study drug.\n21. Patients judged by the investigator to be unsuitable to participate in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},408,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Phase II - Treatment Regimen Exploration Stage:\n\n1. Evaluate the safety and efficacy of the following three treatment regimens:\n\n   Liposomal irinotecan + 5-FU\u002FLV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU\u002FLV + bevacizumab (Group B) Irinotecan + 5-FU\u002FLV + bevacizumab (Group C)\n2. Provide a basis for selecting the treatment regimen for the confirmatory phase.\n3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens.\n\nPhase III - Efficacy Confirmation Stage:\n\nCompare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.",[28,29,30],"Metastatic Colorectal Cancer (CRC)","Liposomal Irinotecan","Second-Line","NOT_YET_RECRUITING","2026-05-07",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":21},"2026-05-20",{"date":39,"type":21},"2032-02-28",{"name":41,"class":42},"Hebei Medical University Fourth Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100510547","phase-1-ramucirumab-cyramza-nal-iri-onivyde-and-trifluridinetipiracil-lonsurf-in-second-line-metastatic-gastric-cancer--100510547","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.","20 Years","80 Years",{"count":54,"type":21},45,[56,24],"PHASE1","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",[59,60,61],"Metastatic Gastric Adenocarcinoma","Second Line","Chemotherapy",[63,64,65],"nal-IRI (ONIVYDE)","TAS-102 (LONSURF)","Ramucirumab (Cyramza)","RECRUITING","2026-04-06",{"date":69,"type":35},"2026-04-09",{"date":71,"type":35},"2024-04-01",{"date":73,"type":21},"2028-12-31",{"name":75,"class":42},"National Health Research Institutes, Taiwan",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100578688","immune-checkpoint-inhibitors-icis-retreatment-in-second-line-treatment-of-advanced-gastric-cancer-a-retrospective-real-world-study-100578688","NCT06814548","Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study","Inclusion Criteria:\n\n* Histologically confirmed metastatic or advanced GC\u002FGEJC;\n* Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;\n* Receiving at least 2 cycles of ICI-based second-line therapy;\n* ECOG PS 0 or 1;\n* Radiographic response was also assessed during treatment and survival.\n\nExclusion Criteria:\n\n* patients had other malignancies within the past 5 years;\n* lack of survival and clinical efficacy data;\n* combined radiotherapy regimens in the second-line treatment.",{"count":83,"type":21},200,"OBSERVATIONAL","This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.",[87,88,89,90],"Gastric Cancer, Gastroesophageal Junction Cancer","Immune Checkpoint Inhibitors (ICIs)","Second-line","Retreatment","2025-02-03",{"date":93,"type":35},"2025-02-07",{"date":95,"type":21},"2025-02-10",{"date":97,"type":21},"2025-05-31",{"name":99,"class":42},"Yongxu Jia"]