[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562794":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":38,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":76,"collaborators":20,"id":80,"slug":20,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":20,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":20,"overallStatus":61,"whyStopped":20,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Guangzhou Institute of Respiratory Disease","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Objective response rate(ORR)","Proportion of target lesions stabilized after two courses of first-line chemoimmunotherapy standard therapy combined with and without PTS intratumoral injection, with tumor volume reduction to achieve complete remission (CR) and partial remission (PR)","3 years",[14,17],{"measure":15,"description":16,"timeFrame":12},"Median progression-free survival(mPFS)","Time from receipt of first-line chemoattenuated standard of care in combination with or without PTS intratumoral injection until first objectively documented disease progression or death from any cause (whichever occurs first)",{"measure":18,"description":19,"timeFrame":12},"Median overall survival(mOS)","Time from receipt of first-line chemoattenuated standard of care in combination with or without PTS intratumoral injection until death from any cause (whichever occurs first)",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Experimental group","EXPERIMENTAL","intratumoral injection of toluenesulfonamide (PTS) to oligo lesions",[33],"Drug: Toluenesulfonamide (PTS) Intratumoral Injection",{"label":35,"type":36,"description":37,"interventionNames":20},"Control subjects","NO_INTERVENTION","follow-up observation of oligofocal lesions, no PTS intratumoral injection treatment, if progression can be oligofocal PTS intratumoral injection",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":20},"DRUG","Toluenesulfonamide (PTS) Intratumoral Injection","intratumoral injection of toluenesulfonamide(PTS) to oligo lesions",[29],[45],{"name":46,"affiliation":47,"role":48},"Chengzhi Zhou, doctor","The First Affiliated Hospital of Guangzhou Medical University,Guangzhou","PRINCIPAL_INVESTIGATOR",[50,54],{"name":46,"role":51,"phone":52,"phoneExt":20,"email":53},"CONTACT","13560351186","doctorzcz@163.com",{"name":55,"role":51,"phone":56,"phoneExt":20,"email":57},"Xiaohong Xie, master","13632326736","gyxxh@126.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"The First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510145","China","CN",{"type":68,"coordinates":69},"Point",[70,71],113.25,23.11667,{"lat":71,"lon":70},[74,75],{"name":46,"role":51,"phone":52,"phoneExt":20,"email":53},{"name":55,"role":51,"phone":56,"phoneExt":20,"email":57},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Zhou Chengzhi","chief physician","100562794",false,"NCT06607796","Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With\u002FWithout Chemoimmunotherapy","A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；\n2. Age ≥18 years and ≤75 years at the time of signing the ICF；\n3. Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；\n4. At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；\n5. Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；\n6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；\n7. Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；\n8. Life expectancy ≥ 3 months；\n9. Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.\n\nExclusion Criteria:\n\n1. Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;\n2. Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;\n3. Have severe bleeding, clotting disorders, infections, dehydration, etc;\n4. Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;\n5. History of severe emphysema and pulmonary alveoli;\n6. History of drug allergy or contraindication to toluene sulfonamide;\n7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;\n8. The investigators determined that the patients had other conditions that made them unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":90,"type":91},180,"ESTIMATED","INTERVENTIONAL",[94],"PHASE3","The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.",[97],"Lung Cancer","2024-09-23",{"date":100,"type":101},"2024-09-25","ACTUAL",{"date":103,"type":101},"2024-03-01",{"date":105,"type":91},"2026-12",{"name":78,"class":6},1]