[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562794":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":57,"collaborators":18,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":18,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Guangzhou Institute of Respiratory Disease","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","intratumoral injection of toluenesulfonamide (PTS) to oligo lesions",[13],"Drug: Toluenesulfonamide (PTS) Intratumoral Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Control subjects","NO_INTERVENTION","follow-up observation of oligofocal lesions, no PTS intratumoral injection treatment, if progression can be oligofocal PTS intratumoral injection",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Toluenesulfonamide (PTS) Intratumoral Injection","intratumoral injection of toluenesulfonamide(PTS) to oligo lesions",[9],[26],{"name":27,"affiliation":28,"role":29},"Chengzhi Zhou, doctor","The First Affiliated Hospital of Guangzhou Medical University,Guangzhou","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","13560351186","doctorzcz@163.com",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Xiaohong Xie, master","13632326736","gyxxh@126.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510145","China","CN",{"type":49,"coordinates":50},"Point",[51,52],113.25,23.11667,{"lat":52,"lon":51},[55,56],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Zhou Chengzhi","chief physician","100562794","phase-3-efficacy-and-safety-of-intratumoral-toluenesulfonamide-pts-injection-in-stage-iv-driver-gene-negative-nsclc-withwithout-chemoimmunotherapy-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":72,"type":73},180,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79],"Lung Cancer","2024-09-23",{"date":82,"type":83},"2024-09-25","ACTUAL",{"date":85,"type":83},"2024-03-01",{"date":87,"type":73},"2026-12",{"name":59,"class":6},1]