[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-cancer-recurrent":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100535962","irinotecan-liposome-combined-with-anlotinib-as-second-line-regimen-for-sclc-100535962",false,"NCT06258642","Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC","Study of Irinotecan Liposome Combined With Anlotinib as Second-line Regimen in Patients With Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\) Aged ≥18 and ≤75 years old;\n* 2\\) Histologically or cytologically confirmed small cell lung cancer;\n* 3\\) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;\n* 4\\) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;\n* 5\\) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n* 6\\) Expected survival of more than 3 months;\n* 7\\) Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment);\n* 8\\) Adequate major organ function, patients should meet the following criteria:\n\n  ① Bone marrow function: absolute neutrophile count (ANC)≥1.5×109\u002FL，platelet (PLT)≥100×109\u002FL, hemoglobin (Hb)≥90g\u002FL, white blood cell (WBC)≥3.0×109\u002FL；\n\n  ② Hepatic function: total bilirubin≤1.5×upper limit of normal value(ULN)；ALT and AST≤2.5×ULN，liver metastasis：≤5×ULN；\n\n  ③ Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL\u002Fmin;\n\n  ④ Coagulation function：Activated partial thromboplastin time(APTT)、International normalized ratio(INR)、prothrombin time (PT)≤1.5×ULN；\n\n  ⑤ urine routines show urine protein \\\u003C 2+(when urine protein \\>2+, urine protein quantity\\\u003C 1.0 g during 24 hours before 7 days);\n* 9\\) Patients fully understood and volunteered to participate in the study.\n\nExclusion Criteria:\n\n* 1\\) Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma;\n* 2\\) Patients with asymptomatic central nervous system (CNS) metastases prior to enrollment or those who have CNS disease requiring increase in the dose of steroid. (Patients with controlled CNS metastasis can participate in the trial);\n* 3\\) Patients with uncontrolled pleural effusion, abdominal effusion and pericardial effusion after repeated drainage or other treatment within 2 weeks prior to the first dose of this study, and those judged by the clinicians to be unsuitable for the study;\n* 4\\) Diagnosed with any other cancer within the past 5 years (except for cured basal cell carcinoma and in situ cancer);\n* 5\\) Patients who have received prior irinotecan\u002F liposomal irinotecan and anti-angiogenic drugs such as anlotinib and bevacizumab , etc.\n* 6\\) Concomitant use of strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week of the first dose of the study drug;\n* 7\\) Patients who have received other anti-tumor treatments(including radiotherapy, chemotherapy, immunotherapy, etc.) within 4 weeks before the first dose;\n* 8\\) Combined with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe ventricular arrhythmia , etc.\n* 9\\) Severe pulmonary disease within 6 months prior to enrolment, such as interstitial pneumonia, pulmonary fibrosis, radiation induced pneumonitis requiring steroid therapy, and other moderate and severe lung diseases which affect lung function;\n* 10\\) Arterial\u002Fvenous thrombosis within 6 months prior to enrollment, e.g. cerebrovascular accident (include temporary ischemic attack), deep venous thrombosis, pulmonary embolism.\n* 11\\) Symptoms or propensity to bleed within 3 months prior to screening (include gastrointestinal hemorrhage, ulcerative gastric bleeding, fecal occult blood 2+ or above, vasculitis);\n* 12\\) Patients had undergone major surgical procedure(except for diagnostic surgery) within 4 weeks before dosing or was scheduled to receive major procedure during the study;\n* 13\\) unhealed wounds, ulcers or fractures;\n* 14\\) Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage;\n* 15\\) Active and uncontrolled bacterial, viral, fungal infection requiring systemic treatment;\n* 16\\) Active hepatitis B\u002FC, or HIV infection;\n* 17\\) Known intolerance or allergy to therapeutic drugs and their excipients;\n* 18\\) Clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \\> grade 1;\n* 19\\) Pregnant or breast feeding;\n* 20\\) Patient is not suitable for the study in the investigator's opinion.","ALL","18 Years","75 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.",[27],"Small Cell Lung Cancer Recurrent",[29,30],"Small Cell Lung Cancer","liposomal irinotecan","RECRUITING","2025-08-14",{"date":34,"type":35},"2025-08-20","ACTUAL",{"date":37,"type":35},"2024-04-17",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Fudan University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100565901","phase-2-toripalimab-and-js004-combined-with-platinum-based-chemotherapy-for-relapsed-and-extensive-stage-small-cell-lung-cancer-100565901","NCT06648200","Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer","Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form;\n2. Aged 18 ≥ years;\n3. Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;\n5. Life expectancy is at least 12 weeks;\n6. At least 1 measurable lesion according to RECIST 1.1;\n7. Patients with good function of other main organs (liver, kidney, blood system, etc.);\n8. Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;\n9. Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.\n\nExclusion Criteria:\n\n1. Patients with a malignancy other than SCLC within five years prior to the start of this trial;\n2. Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);\n3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;\n4. Participants who are allergic to the test drug or any auxiliary materials;\n5. Participants with active hepatitis B, hepatitis C or HIV;\n6. Participants with Interstitial lung disease currently;\n7. Pregnant or lactating women;\n8. Any malabsorption;\n9. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;\n10. Other factors that researchers think it is not suitable for enrollment.",{"count":52,"type":21},100,[54],"PHASE2","For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.",[57,27],"Small Cell Lung Cancer Extensive Stage",[59,60,61,62,63],"small cell lung cancer","Toripalimab","JS004","Extensive-stage","Recurrent","NOT_YET_RECRUITING","2024-10-16",{"date":67,"type":35},"2024-10-18",{"date":69,"type":21},"2024-11-01",{"date":71,"type":21},"2030-09-01",{"name":73,"class":42},"Shanghai Pulmonary Hospital, Shanghai, China"]