[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangxi Provincial People's Hopital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100581293","xingbai-ji-formula-combined-with-chemotherapy-and-sintilimab-in-metastatic-multi-target-mutation-negative-non-small-cell-lung-cancer-a-clinical-trial-100581293",false,"NCT06848426","Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial","A Clinical Study of Xingbaiji Formula in Combination with Chemotherapy and Sintilimab As First-Line Treatment for Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Age: 18-75 years, regardless of gender.\n3. Histologically or cytologically confirmed non-small cell lung cancer (NSCCC), including adenocarcinoma, squamous cell carcinoma, or large cell carcinoma, with negative EGFR, ALK, and ROS-1 mutations confirmed by next-generation sequencing (NGS). Stage IIIB-IV NSCLC as per AJCC 8th edition staging criteria (required evaluations: neck contrast-enhanced CT or ultrasound, chest contrast-enhanced CT, abdominal contrast-enhanced CT or ultrasound, brain contrast-enhanced MRI, bone scan, or whole-body PET\u002FCT).\n4. ECOG performance status ≤2 and life expectancy ≥3 months.\n5. Histologically or cytologically documented ineligibility for EGFR, ALK, or ROS-1 targeted therapies (written evidence required).\n6. At least one measurable lesion per RECIST v1.1. Lesions within prior radiation fields or post-local treatment may be selected if progression is confirmed.\n7. No prior systemic anti-tumor therapy for advanced disease. Adjuvant chemotherapy is permitted if ≥6 months have elapsed between recurrence and the last dose.\n\nExclusion Criteria:\n\n1. History of or concurrent other malignancies (excluding non-invasive tumors such as cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);\n2. Individuals with allergic reactions to the Xingbaiji formula;\n3. Patients with mixed small cell lung cancer or those with a small cell lung cancer component;\n4. Severe mental illness or cognitive impairment that would impede compliance with study protocols or follow-up requirements;\n5. Pregnant or lactating women (a pregnancy test must be performed to exclude pregnancy; women of childbearing age must agree to use effective contraception during the study);\n6. Presence of any major illness or significant laboratory abnormalities that may interfere with receiving Xingbaiji formula, chemotherapy, or immunotherapy; 7Any other conditions deemed by the investigators to render participation in the trial inappropriate.","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Clinical Trial Protocol\n\nPrimary Objective:\n\nTo evaluate the efficacy of the Xingbaiji Formula combined with chemotherapy and Sintilimab as first-line therapy in patients with recurrent or metastatic Stage IIIB-IV EGFR\u002FALK\u002FROS-1 mutation-negative non-small cell lung cancer (NSCLC), using Objective Response Rate (ORR) of tumor lesions as the primary endpoint.\n\nSecondary Objectives:\n\nTo assess secondary endpoints including Progression-Free Survival (PFS), Quality of Life (QoL), immune-related indicators, and safety profile (e.g., incidence of adverse events), and to further evaluate the efficacy and safety of the combination therapy.\n\nRandomized Group Allocation:\n\nParticipants will be randomly assigned to two groups:\n\nControl Group\n\nRegimen for Advanced Non-Squamous NSCLC:\n\nDrugs and Dosage:\n\nSintilimab 200mg + Pemetrexed + Cisplatin\u002FCarboplatin via intravenous infusion, administered every 3 weeks (Q3W) for 4 cycles.\n\nAfter completion of 4 cycles, patients enter the maintenance phase: Sintilimab 200mg Q3W (up to 24 months) + Pemetrexed Q3W until disease progression, intolerable toxicity, death, or voluntary withdrawal.\n\nRegimen for Advanced Squamous NSCLC:\n\nDrugs and Dosage:\n\nSintilimab 200mg + Gemcitabine + Cisplatin\u002FCarboplatin via intravenous infusion, Q3W for 4-6 cycles.\n\nPost-treatment, patients receive Sintilimab 200mg Q3W maintenance until disease progression, intolerability, or completion of 2 years of Sintilimab therapy.\n\nExperimental Group Control Group Regimen + Xingbaiji Formula\n\nXingbaiji Formula Dosage:\n\n1. Granule No. 1: 10g\u002Fbag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals.\n2. Granule No. 2: 5g\u002Fbag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals. Treatment Duration: Both granules are taken concurrently with chemotherapy for 6 months, then discontinued.",[27,28,29,30,31],"Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer Recurrent","Non-small Cell Lung Cancer Stage IIIB","Non-small Cell Lung Cancer Stage IV","Non-small Cell Lung Cancer Metastatic","NOT_YET_RECRUITING","2025-02-23",{"date":35,"type":36},"2025-02-27","ACTUAL",{"date":38,"type":21},"2025-03-10",{"date":40,"type":21},"2028-01-31",{"name":42,"class":43},"Jiangxi Provincial People's Hopital","OTHER",""]