[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jianxing He\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":168},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,72,98,124,145],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100643404","single-center-intelligent-pulmonary-rehabilitation-after-lung-cancer-surgery-100643404",false,"NCT07631533","Single-Center Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery","A Randomized Controlled Trial of an Intelligent Pulmonary Function Exercise Device Versus Usual Care for In-Hospital and Home-Based Pulmonary Rehabilitation After Lung Cancer Surgery","Inclusion Criteria:\n\n* 1\\. Age 18 to 75 years. 2. Pathologically confirmed primary non-small cell lung cancer. 3. Scheduled to undergo elective thoracoscopic lobectomy or sublobar resection. 4. Able to understand the study and voluntarily sign written informed consent before surgery.\n\n  5\\. Able to communicate and complete study assessments and postoperative follow-up.\n\n  6\\. Able to use a smartphone independently or with assistance from a caregiver for training records.\n\n  7\\. Good lung re-expansion on postoperative chest imaging. 8. No chest tube drainage or no persistent air leak from chest tube drainage. 9. Clinical stage cT1-T2b, N0-N1, M0, stage IA-IIB. 10. Home environment allows safe training.\n\nExclusion Criteria:\n\n* 1\\. Preoperative measured FEV1 less than 50% of predicted value. 2. Severe cardiopulmonary dysfunction or other conditions judged unsuitable for respiratory training.\n\n  3\\. Previous thoracic surgery or major thoracic trauma. 4. Significant cognitive impairment or psychiatric disorder that prevents cooperation with the study.\n\n  5\\. Pregnancy or breastfeeding. 6. Recent severe infection or active pulmonary disease.","ALL","18 Years","75 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will compare an intelligent pulmonary function exercise device with usual care and natural recovery in patients recovering from lung cancer surgery.\n\nAfter lung cancer surgery, many patients have reduced lung function, shortness of breath, lower exercise tolerance, and a risk of postoperative pulmonary complications. Standard care usually includes postoperative nursing, pain control, coughing and sputum clearance instruction, early mobilization, discharge education, and routine follow-up. However, patients often lack structured guidance, feedback, and monitoring after discharge.\n\nParticipants in this study will be randomly assigned to one of two groups. One group will use an intelligent pulmonary function exercise device for respiratory training during hospitalization and at home until 30 days after surgery. The prescribed training is two sessions per day, with each session including 30 expiratory training repetitions and 30 inspiratory training repetitions. The device records training completion and related training information and provides reminders and feedback. The other group will receive usual perioperative care, standard discharge education, and natural recovery follow-up without a study-specified respiratory training device or training prescription.\n\nThe main purpose of the study is to determine whether the intelligent pulmonary function exercise device improves recovery of forced expiratory volume in 1 second, or FEV1, from before surgery to 30 days after surgery. The study will also evaluate lung function at 90 days, symptoms, quality of life, walking capacity, training adherence, and postoperative complications.",[27],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-06-02",{"date":31,"type":32},"2026-06-08","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2028-12",{"name":38,"class":39},"Jianxing He","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100630797","phase-2-fulzerasib-sequential-sintilimab-plus-platinum-doublet-neoadjuvant-therapy-for-resectable-kras-g12c-mutant-nsclc-100630797","NCT07492342","Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC","Evaluation of Efficacy and Safety of Fulzerasib Sequentially Combined With Sintilimab Plus Platinum-Doublet Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer With KRAS G12 Mutation: a Single-Arm, Phase II Clinical Trial","K-NADIR","Inclusion Criteria:\n\n1. Sign the Informed Consent Form (ICF) and be able to comply with the visit and related procedures as stipulated in the protocol.\n2. Be male or female, aged ≥18 years old.\n3. Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC).\n4. Clinical stage IB to IIIA disease, according to the 8th edition of the TNM classification for lung cancer as defined by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).\n5. All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation; and must have no sensitive mutations of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK).\n6. The patient is deemed by a thoracic surgeon to be a candidate for curative resection (R0 resection) and has adequate pulmonary function to undergo the planned pulmonary resection.\n7. Have at least one measurable lesion according to RECIST 1.1 criteria.\n8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n9. Have not received any systemic anti-tumor treatment for locally advanced or metastatic NSCLC before.\n10. Have adequate organ and bone marrow function (subjects who have received any cell or growth factor therapy within 2 weeks before the first administration of the study drug should be excluded), defined as follows:\n\n1\\) Blood routine: Absolute neutrophil count (ANC) ≥1.5×109\u002FL or within the normal range; platelet (PLT) count ≥100×109\u002FL; hemoglobin (HGB) content ≥9.0 g\u002FdL.\n\n2\\) Liver function: Serum total bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.\n\n3\\) Renal function: Serum creatinine (Cr) ≤1.5×ULN or clearance of creatinine (CCr) ≥50 mL\u002Fmin, calculated by the Cockcroft-Gault formula (using actual body weight); urine routine test shows urine protein \\\u003C2+; for subjects with urine protein ≥2+ at baseline as detected by urine test strips, a 24-hour urine collection should be performed and the protein content in 24-hour urine should be \\\u003C1 g (if both methods are used, the value obtained from 24-hour urine collection will be used to determine eligibility).\n\n4\\) Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN and International Normalized Ratio (INR) ≤ 1.5; 11. Female subjects of childbearing age or male subjects whose partners are of childbearing age must take effective contraceptive measures throughout the treatment period and for 180 days after the treatment.\n\n12.Female subjects have evidence of postmenopausal status, or the urine or serum pregnancy test results of premenopausal female subjects are negative.\n\nExclusion Criteria:\n\n1. Histological or cytological pathology confirms the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumors, or mesenchymal tumor components.\n2. Tumor invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina.\n3. Superior sulcus (Pancoast) tumor.\n4. Presence of tumor nodules in the contralateral lung lobe. Biopsy is required to confirm if contralateral lung nodules are clinically suspected.\n5. Documented brain metastasis. Patients with suspected brain metastasis must undergo brain imaging for further confirmation.\n6. Have significant cardiovascular or cerebrovascular diseases, such as:\n\n1)Experienced definite cardiovascular abnormal events within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or undergone angioplasty, vascular stent implantation, coronary artery bypass surgery, etc.\n\n2)Have clinically significant QT\u002FQTcF interval prolongation (QTcF \\> 470ms for females or \\> 450ms for males).\n\n7.Significant or active gastrointestinal disease characterized by diarrhea as the major symptom.\n\n8.Receipt of strong inhibitors or strong inducers of CYP3A4 or P-gp within 14 days prior to the first dose of study treatment, or within 5 half-lives of such agents (whichever is longer), or use of traditional Chinese medicine within 7 days prior to the first dose of study treatment.\n\n9.Participants who have received known CYP2D6, CYP3A4, P-gp, and BCRP sensitive substrates within 14 days or 5 half-lives (whichever is longer) before the first dose of this study, and the therapeutic window of the substrate is narrow, unless agreed by the investigator and the sponsor to be enrolled.\n\n10.Receipt of proton pump inhibitors (PPIs) or H2 receptor antagonists within 7 days prior to the first dose of study treatment.\n\n11.Systemic therapy with Chinese herbal medicines with anti-tumor indications or immunomodulatory agents (including thymopeptides, interferons, interleukins) within 2 weeks prior to the first dose of study treatment.\n\n12.Participants who are simultaneously involved in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the follow-up stage after the end of an interventional study.\n\n13.Participants who have received live attenuated vaccines within 4 weeks before the first dose of study treatment or plan to receive them during the study period.\n\nNote: Inactivated virus vaccines for seasonal influenza by injection are allowed within 4 weeks before the first dose of study treatment; however, live attenuated influenza vaccines are not allowed.\n\n14.Patients requiring long-term systemic corticosteroid use. Any other form of immunosuppressive therapy within 7 days prior to randomization.\n\nNote: Topical glucocorticoids (nasal, inhaled, or other routes), physiological doses of systemic glucocorticoids (≤10 mg\u002Fday prednisone or equivalent), or use for pre-medication (e.g., prevention of contrast agent allergy) are permitted.\n\n15.Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or presence of non-healing wounds, ulcers, or fractures.\n\n16.History of radiation pneumonitis, idiopathic pneumonitis, active pneumonitis, pulmonary fibrosis, diffuse interstitial lung disease, or organizing pneumonia (e.g., bronchiolitis obliterans).\n\n17.Participants with known allergies to study treatment or any of its components.\n\n18.Known primary immunodeficiency. 19.Active autoimmune or inflammatory disease (including inflammatory bowel disease \\[e.g., colitis, Crohn's disease\\], diverticulitis \\[excluding diverticulosis\\], celiac disease, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis (Wegener's syndrome), Graves' disease, hypophysitis, uveitis, etc.), or history of such disease within the previous 2 years.\n\nPatients with vitiligo, psoriasis, alopecia that do not require systemic therapy within the past 2 years, hypothyroidism requiring only thyroid hormone replacement, and type 1 diabetes mellitus requiring only insulin replacement are eligible.\n\n20.Have major acute or chronic infections, including:\n\n1. Active infections requiring systemic treatment;\n2. Positive human immunodeficiency virus antibody (HIV-Ab) at baseline;\n3. Active hepatitis B virus (HBV) infection (positive HBsAg and positive HBV-DNA). For patients with negative HBsAg and positive HBcAb, HBV-DNA testing is required; patients with positive HBV-DNA are excluded;\n4. Active hepatitis C virus (HCV) infection (positive HCV-Ab and positive HCV-RNA);\n5. Active pulmonary tuberculosis,, receiving anti-tuberculosis therapy, or having received anti-tuberculosis therapy within 1 year prior to the first dose of study treatment\n6. Active syphilis. 21.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n22.Diagnosis of another malignancy within 5 years prior to the first dose,except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,radically resected carcinoma in situ, radically treated localized prostate cancer, papillary thyroid carcinoma, and similar diseases.\n\n23.Uncontrolled concurrent disease, including:\n\n1)Serious infection occurring within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; or therapeutic oral or intravenous antibiotics administered within 2 weeks prior to initiation of study treatment; 2)Symptomatic congestive heart failure (New York Heart Association Class III-IV), left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography, or uncontrolled cardiac arrhythmia; 3)Uncontrolled hypertension despite standard therapy (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg); 4)Uncontrolled or symptomatic hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or serum calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN); 5)Esophageal or gastric varices requiring immediate intervention (e.g., banding or sclerotherapy), or subjects with evidence of portal hypertension (including splenomegaly on imaging) or a history of variceal bleeding considered to be at high risk of bleeding by the investigator or in consultation with a gastroenterologist or hepatologist; endoscopic evaluation must be performed within 3 months prior to enrollment; 6)History of deep vein thrombosis or any other severe thromboembolism within 3 months prior to enrollment (implanted venous access port or catheter-related thrombosis, or superficial venous thrombosis is not considered severe); 7）Any life-threatening hemorrhagic event within 3 months prior to enrollment; 8)Uncontrolled metabolic disorders or other acute or chronic non-malignant organ or systemic diseases, or paraneoplastic syndromes that may confer high medical risk and\u002For uncertainty in survival assessment; 9)History of gastrointestinal perforation and\u002For fistula within 6 months prior to enrollment; 10)Subjects at risk of intestinal obstruction or perforation (including but not limited to acute diverticulitis, intra-abdominal abscess, history of intra-abdominal cancer), or history of extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; 11)Significant malnutrition requiring intravenous nutritional supplementation, unless malnutrition had been corrected for more than 4 weeks prior to the first dose of study treatment; 12)Post-placement of intraluminal esophageal or tracheal stents; 13)Other acute or chronic medical conditions that may increase risk related to study participation or study drug administration, interfere with the interpretation of study results, or are deemed by the investigator to render the subject ineligible for the study; 14)Neurological, psychiatric, or social conditions that would impair compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent (e.g., schizophrenia, history of drug abuse, etc.).\n\n24.Pregnant or lactating women",{"count":49,"type":21},30,[51],"PHASE2","This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation.\n\nApproximately 30 treatment-naïve patients with stage IB-IIIA (AJCC 8th edition) NSCLC and confirmed KRAS G12C mutation will be enrolled.\n\nEligible subjects will receive 6 weeks of fulzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy.\n\nAn end-of-treatment visit will be performed within 7 days after the last dose of neoadjuvant therapy.",[54,55,56,57],"Resectable NSCLC","KRAS G12C Mutation","Stage IB-IIIA NSCLC","Neoadjuvant Therapy",[57,59,60,61],"Fulzerasib","Sintilimab","Platinum-Based Combination Chemotherapy","RECRUITING","2026-03-19",{"date":65,"type":32},"2026-03-25",{"date":67,"type":32},"2026-01-29",{"date":69,"type":21},"2027-12-31",{"name":38,"class":39},3,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":4},"100621938","tubeless-spontaneous-ventilation-anesthesia-in-kidney-transplantation-100621938","NCT07377123","Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation","Application of Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation Surgery: A Single-Center, Prospective, Randomized Controlled Trails","Inclusion Criteria:\n\n1. No gender restriction, age 18-65 years (including upper and lower limits).\n2. First-time recipient of citizen organ donation kidney transplantation.\n3. Type of citizen organ donation must be Category I China (Donation after Brain Death DBD).\n4. Donor and recipient blood type identical.\n5. Panel reactive antibody (PRA) results negative within six months preoperatively.\n6. Body mass index (BMI) \\\u003C28 kg\u002Fm².\n7. No severe pulmonary ventilation or gas exchange dysfunction, preoperative pulmonary function assessment meets kidney transplantation requirements, preoperative chest CT shows no significant abnormalities.\n8. No severe arrhythmia (frequent atrial fibrillation or ventricular premature beats), normal cardiac function (ejection fraction \\> 50%).\n9. American Society of Anesthesiologists (ASA) physical status classification ≤ III.\n10. Voluntarily participate in clinical research, fully understand this study and voluntarily sign the informed consent form, and complete all trial procedures.\n\nExclusion Criteria:\n\n1. Combined multi-organ transplantation.\n2. Previous history of organ transplantation other than kidney.\n3. Living donor kidney transplantation.\n4. If one of the two patients receiving a kidney from the same donor does not meet the inclusion criteria, the other patient is also excluded.\n5. Previous history of mental illness, current psychological assessment does not meet transplantation criteria.\n6. Other situations where the organ transplant physician assesses the patient as not suitable for transplantation.\n7. Poor compliance of the recipient or other situations deemed by the researcher as unsuitable for inclusion in the trial.","65 Years",{"count":81,"type":21},60,[24],"The aim of this clinical trial is to compare the intraoperative use of neuromuscular blocking agents and other anesthetic drugs between tubeless spontaneous ventilation anesthesia (TSVA) and conventional endotracheal intubation (ETT) anesthesia in kidney transplantation. The study will also evaluate the safety, stability, and postoperative recovery associated with TSVA.\n\nThis trial is designed to address the following questions:\n\n* Does TSVA reduce the intraoperative requirement for neuromuscular blocking agents and other anesthetic medications?\n* Does TSVA improve postoperative outcomes in kidney transplant recipients?\n* How do the intraoperative safety and stability of TSVA compare with those of ETT anesthesia?\n\nResearchers will compare anesthetic drug consumption, intraoperative anesthetic performance, and postoperative recovery outcomes between the TSVA and ETT groups to determine whether TSVA can decrease anesthetic drug use and enhance patient recovery.\n\nParticipants will:\n\n* Undergo a complete preoperative assessment\n* Receive kidney transplantation under TSVA or ETT anesthesia, with relevant intraoperative data recorded\n* Receive tubeless postoperative management, with documentation of pain scores, complications, and recovery of graft function\n* Be followed throughout their lifetime after discharge, providing long-term follow-up information",[85,86],"Kidney Transplantation","CKD (Chronic Kidney Disease) Stage 5D",[88,89,90,91],"kidney transplantation","tubeless","ERAS","anesthesia","2026-01-22",{"date":67,"type":32},{"date":95,"type":21},"2026-01-12",{"date":69,"type":21},{"name":38,"class":39},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100606557","phase-2-primary-tumor-resection-with-sintilimab-and-chemotherapy-in-advanced-nsclc-100606557","NCT07177105","Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC","Primary Tumor Resection Combined With Sintilimab and Chemotherapy for Advanced Non-small-cell Lung Cancer: A Randomized Controlled Trial","SURGAN-ICI","Inclusion Criteria:\n\n1. Age 18-75 years, no sex limitation;\n2. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, deemed unresectable (evaluated by MDT);\n3. Negative for EGFR mutation and ALK rearrangement (tested by ARMS-PCR, NGS, or equivalent methods);\n4. No histological evidence of small cell lung cancer (SCLC) or transformation to SCLC;\n5. No prior exposure to anti-tumor therapy;\n6. ECOG performance status of 0-1;\n7. Expected survival ≥ 6 months;\n8. Primary tumor diameter ≥ 1 cm, with at least one measurable lesion remaining after resection (per RECIST v1.1 criteria);\n9. Adequate major organ function, including:\n\n   ① Hematologic: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, platelets ≥ 100 × 10⁹\u002FL, hemoglobin ≥ 9.0 g\u002FdL;\n\n   ② Hepatic: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN in case of liver metastases), total bilirubin ≤ 1.5 × ULN;\n   * Renal: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n10. Pulmonary function (patients must meet at least one of the following to ensure adequate postoperative pulmonary reserve):\n\n    ① FEV1 ≥ 1.2 L (or ≥ 40% of predicted value);\n\n    ② FEV1\u002FFVC ≥ 0.7, excluding severe obstructive ventilatory impairment;\n\n    ③ DLCO (diffusing capacity for carbon monoxide) ≥ 40% of predicted value, to assess diffusion capacity;\n\n    ④ If preoperative FEV1 \\\u003C 1.2 L or DLCO \\\u003C 40%, a quantitative perfusion scan is recommended along with preoperative exercise testing (e.g., 6-minute walk test, stair-climbing test) to evaluate residual pulmonary function;\n11. Preoperative assessment by the study team confirming that the patient can tolerate primary lesion resection;\n12. Signed informed consent with willingness to comply with study protocol.\n\nExclusion Criteria:\n\n1. Impaired immune function: history of primary immunodeficiency; history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n2. Active brain metastases. Patients with adequately treated brain metastases may be eligible if they have remained neurologically stable for at least 2 weeks prior to study entry and are not receiving systemic corticosteroids or are on a stable\u002Freducing dose equivalent to ≤10 mg prednisone daily.\n3. Pregnancy.\n4. Presence of any severe, uncontrolled, or unstable comorbidity that, in the opinion of the investigator, may interfere with the patient's participation in the study or affect the interpretation of study results, including uncontrolled seizures, psychiatric disorders, active or uncontrolled infections, or other conditions (including laboratory abnormalities).",{"count":107,"type":21},118,[51],"This study aims to evaluate whether resecting the primary tumor can improve the outcomes of treatment with sintilimab and chemotherapy in advanced EGFR\u002FALK-negative non-small cell lung cancer (NSCLC). Patients will be randomly assigned to one of two groups: one group will undergo primary tumor resection followed by sintilimab, pemetrexed, and carboplatin, while the other group will only receive sintilimab, pemetrexed, and carboplatin. The study will assess progression-free survival, overall survival, treatment response, safety, and the impact of treatment on quality of life. Through this study, we hope to determine whether primary tumor resection can provide additional benefits of anti-PD-1 therapy and chemotherapy for advanced NSCLC.",[111],"Non Small Cell Lung Cancer",[60,113,114,115],"Chemotherapy","Surgery","Advanced NSCLC","2025-09-12",{"date":118,"type":32},"2025-09-16",{"date":120,"type":21},"2025-09-10",{"date":122,"type":21},"2030-10-01",{"name":38,"class":39},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100606556","phase-2-primary-tumor-resection-plus-osimertinib-in-advanced-egfr-mutant-non-small-cell-lung-cancer-100606556","NCT07177092","Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer","Efficacy and Safety of Primary Tumor Resection Combined With Osimertinib in Patients With Advanced EGFR-mutant Non-small Cell Lung Cancer: A Randomized Controlled Study","SURGAN-TKI","Inclusion Criteria:\n\n1. Age 18-75 years, no restriction on sex.\n2. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, unresectable as assessed by multidisciplinary team (MDT).\n3. Presence of EGFR exon 19 deletion (19Del) or L858R mutation, confirmed by ARMS-PCR, NGS, or other validated methods.\n4. No prior systemic therapy for lung cancer.\n5. ECOG performance status of 0-1.\n6. Estimated life expectancy of at least 6 months.\n7. Primary lung tumor size ≥1 cm, with at least one measurable lesion remaining after resection according to RECIST v1.1 criteria.\n8. Adequate organ function, including:\n\n   ① Hematologic function: absolute neutrophil count ≥1.5 × 10⁹\u002FL; platelet count ≥100 × 10⁹\u002FL; hemoglobin ≥9.0 g\u002FdL.\n\n   ② Hepatic function: ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases are present); total bilirubin ≤1.5 × ULN.\n\n   ③ Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n9. Adequate pulmonary function (must meet at least one of the following to ensure postoperative reserve):\n\n   ① FEV1 ≥1.2 L (or ≥40% of predicted value);\n\n   ② FEV1\u002FFVC ≥0.7, to exclude severe obstructive ventilatory dysfunction;\n\n   ③ DLCO (diffusing capacity for carbon monoxide) ≥40% of predicted value, to assess diffusion capacity.\n\n   ④ If preoperative FEV1 \\\u003C1.2 L or DLCO \\\u003C40%, additional cardiopulmonary exercise testing (e.g., 6-minute walk test, stair climbing test) is recommended to evaluate postoperative pulmonary reserve.\n10. Evaluated by the study team and deemed suitable for primary tumor resection.\n11. Signed written informed consent and willingness to comply with study protocol.\n\nExclusion Criteria:\n\n1. Presence of any other known EGFR mutations.\n2. Histological evidence of mixed small-cell lung cancer (SCLC) or history of transformation to SCLC.\n3. Immunodeficiency: history of primary immunodeficiency disorders, or prior allogeneic organ or bone marrow transplantation.\n4. Active brain metastases. Patients with adequately treated brain metastases may be eligible if they are neurologically stable for at least 2 weeks before enrollment, and are either not requiring corticosteroids or receiving a stable or decreasing dose of ≤10 mg prednisone (or equivalent) once daily.\n5. Pregnancy.\n6. Any serious comorbid condition that, in the opinion of the investigator, may interfere with participation in the study or interpretation of study results, including but not limited to: uncontrolled systemic diseases, psychiatric illness, active or uncontrolled infections, or other abnormal findings from laboratory or clinical examinations.",{"count":107,"type":21},[51],"This study is designed to explore whether resecting the primary lung cancer, followed by osimertinib, can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) harboring sensitizing EGFR mutations (exon 19 deletion or L858R). Patients with stage III-IV NSCLC will be included and randomly assigned to receive either surgery to remove the primary lung cancer followed by osimertinib, or osimertinib alone. All patients will continue treatment until disease progression or they need to stop for another reason. The primary outcome being studied is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse effects (AEs), serious adverse effects (SAEs) and quality of life (QoL). The findings from this study may help determine whether surgery combined with EGFR tyrosine kinase inhibitor (TKI) provides more benefit than EGFR-TKI alone for patients with EGFR-mutant advanced NSCLC.",[27,136],"EGFR",[27,136,138,114],"Randomized controlled trial",{"date":118,"type":32},{"date":141,"type":21},"2025-09-08",{"date":143,"type":21},"2030-12-01",{"name":38,"class":39},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100601420","ai-based-deepgem-tool-for-predicting-gene-mutations-in-nsclc-patients-a-randomized-controlled-study-100601420","NCT07110259","AI-Based DeepGEM Tool for Predicting Gene Mutations in NSCLC Patients: A Randomized Controlled Study","Application of the Artificial Intelligence-Based Gene Mutation Prediction Tool DeepGEM in Patients With Non-Small Cell Lung Cancer (NSCLC): A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive, at the time of enrollment.\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with clinical stage II-IV as per the 8th edition of the AJCC staging system.\n* Availability of qualified histopathological whole-slide images that can be reviewed through the KindMED system(DeepGEM).\n* Successful mutation prediction of EGFR, ALK, or ROS1 by the DeepGEM AI tool.\n* No prior systemic anti-cancer therapy, including chemotherapy, targeted therapy, or immunotherapy.\n* Willing and able to comply with study requirements, including follow-up and treatment; written informed consent must be provided.\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy-including but not limited to monoclonal antibodies or tyrosine kinase inhibitors) before enrollment.\n* Failure of DeepGEM analysis or unqualified histopathological image quality.\n* History of any other malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma (e.g., cervical carcinoma in situ).\n* Cognitive or psychological barriers to understanding or accepting AI-based prediction or molecular testing.\n* Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception.\n* Any other clinical condition that, in the opinion of the investigators, may interfere with the study protocol or compromise participant safety, including poor compliance with study procedures.",{"count":153,"type":21},950,[24],"This prospective, multicenter, randomized controlled trial aims to evaluate the clinical utility of DeepGEM, an artificial intelligence (AI)-based mutation prediction tool based on histopathological whole-slide images, in patients with non-small cell lung cancer (NSCLC). The study will assess whether DeepGEM can facilitate molecular testing, increase targeted therapy utilization, and improve survival outcomes in a real-world clinical setting. Patients with stage II-IV treatment-naïve NSCLC and qualified pathology slides for DeepGEM analysis will be enrolled. Eligible participants with AI-predicted EGFR, ALK, or ROS1 mutations will be randomized in a 4:1 ratio to either the DeepGEM-informed group (clinicians can access AI results to guide further testing and treatment) or the standard care group (clinicians are blinded to AI results and follow routine care).",[157],"Non Small Cell Lung Caner",[159,160],"Artificial intelligence","gene mutations","2025-07-31",{"date":163,"type":32},"2025-08-07",{"date":161,"type":21},{"date":166,"type":21},"2028-07-31",{"name":38,"class":39},""]