[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chang Chen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100619972","phase-1-chemotherapy-plus-pitavastatin-guided-by-patient-derived-tumor-like-cell-clusters-in-refractory-non-small-cell-lung-cancer-100619972",false,"NCT07351565","Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer","Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer: An Exploratory Phase I Trial","CPPGPTCLC","Inclusion Criteria:\n\n* Age: 18 to 75 years old.\n* Non-small cell lung cancer diagnosed through pathological methods (including histology or cytology).\n* Resistance to second-line drug therapy, with imaging (based on RECIST 1.1 criteria) confirming tumor response as either progressive disease (PD) or stable disease (SD).\n* Presence of measurable lesions according to RECIST 1.1 criteria: tumor lesions must have a CT scan length of ≥ 10 mm; lymph node lesions must have a CT scan short diameter of ≥ 15 mm; scan slice thickness should not exceed 5 mm; and measurable lesions must not have undergone local treatments such as radiotherapy or cryotherapy.\n* ECOG Performance Status: 0-2 points.\n* Expected survival period of at least 6 months.\n* Hematological function is considered sufficient, defined as: absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 80 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL (no history of blood transfusion within the past 7 days, and not corrected with G-CSF or other hematopoietic stimulating factors).\n* Adequate liver function defined as having total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the ULN.\n* Adequate renal function, defined as a creatinine clearance rate of ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n* Adequate coagulation function defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times the upper limit of normal (ULN). If the subject is receiving anticoagulant therapy, coagulation function is considered adequate as long as the INR\u002FPT values fall within the therapeutic range specified for the anticoagulant medication.\n* For female subjects of childbearing age, a negative urine or serum pregnancy test must be conducted within three days prior to the first administration of the study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.\n* If there is a risk of conception, male and female patients should use highly effective contraception (i.e., methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable.\n* The subjects voluntarily joined this study, signed a written informed consent form before any trial-related procedures were implemented, demonstrated good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* Individuals known to be allergic to the active or inactive ingredients of pitavastatin, or to drugs with chemical structures similar to pitavastatin.\n* Individuals with known allergies to pemetrexed, paclitaxel, gemcitabine, or platinum.\n* Active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction requiring clinical intervention.\n* Symptomatic, uncontrolled brain metastases or leptomeningeal metastases, or controlled brain metastases with symptoms lasting less than 2 months.\n* Diagnosed with malignant tumors other than small cell lung cancer within two years prior to enrollment, excluding completely treated basal or squamous cell skin cancer and\u002For radically resected in situ cancer.\n* Has undergone major surgery within the 4 weeks prior to the start of the study or has experienced complications or sequelae that have not yet resolved.\n* Suffering from serious or uncontrolled illnesses, including but not limited to: uncontrollable nausea and vomiting; inability to alleviate symptoms of intestinal obstruction; inability to swallow study medications; gastrointestinal diseases that may interfere with drug absorption and metabolism; respiratory syndrome caused by pleural effusion or ascites (≥ CTCAE grade 2 dyspnea); active viral infections (HIV, HBV, HCV); or uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders hindering informed consent.\n* Having a tendency to bleed and a history of thrombosis, specifically:\n* Any bleeding events of CTCAE grade 2 occurring within the first 3 months of screening, or grade 3 or higher within the first 6 months.\n* Active bleeding, coagulation dysfunction, bleeding tendency, or current treatment with thrombolytic or anticoagulant therapy.\n* Requirement for anticoagulant therapy with medications such as warfarin or heparin.\n* Requirement for long-term antiplatelet therapy, such as aspirin or clopidogrel.\n* Thrombotic or embolic events within the past six months (including CVA\u002FTIA and pulmonary embolism).\n* Significant cardiovascular history, specifically:\n* NYHA Class III and IV congestive heart failure.\n* Unstable angina, newly diagnosed angina, or myocardial infarction within the previous 12 months.\n* Arrhythmia requiring therapeutic intervention (patients taking beta blockers or digoxin may be enrolled).\n* CTCAE Grade ≥ 2 valvular heart disease.\n* Poor control of hypertension (systolic BP \\> 150 mmHg or diastolic BP \\> 100 mmHg).\n* History of non-infectious pneumonia requiring corticosteroid treatment within one year prior to enrollment, or a current diagnosis of non-infectious pneumonia.\n* Any past or current diseases, treatments, or laboratory abnormalities that may interfere with the research results, affect the patient's full participation, or lead the researcher to believe that the patient is unsuitable to participate.","ALL","18 Years","75 Years",{"count":21,"type":22},22,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The primary objective of this study is to evaluate the objective response rate (ORR = CR + PR) of pitavastatin combined with chemotherapy, guided by PTC (patient-derived tumor-like cell cluster) drug sensitivity, in patients resistant to second-line treatment (PD\u002FSD). The ORR is defined as the proportion of patients achieving a response after four cycles of combination therapy. The main questions it aims to answer are:\n\n1. Does PTC-guided medication is feasible\n2. Does the administration of Pitavastatin combined with chemotherapy can improve the objective response rate (ORR) in second-line drug-resistant patients\n\nThe medication to participants will be strictly guided by PTC drug testing. The drugs examined in this study included chemotherapy agents such as cisplatin for injection, carboplatin for injection, pemetrexed disodium for injection, paclitaxel injection, gemcitabine hydrochloride for injection, and docetaxel injection, as well as pitavastatin. The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first.\n\nPirvastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. Participants must demonstrate good compliance throughout the entire study, especially when the dosage is reduced, to ensure they receive the correct prescribed dose.",[28],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-01-09",{"date":32,"type":33},"2026-01-20","ACTUAL",{"date":35,"type":22},"2026-01-10",{"date":37,"type":22},"2026-12-31",{"name":39,"class":40},"Chang Chen","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100611698","multi-omics-based-prediction-of-allograft-dysfunction-after-lung-transplantation-100611698","NCT07243964","Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation","Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation: A Prospective, Multicenter Cohort Study","Inclusion Criteria:\n\n1. Recipients aged ≥18 years undergoing single or double lung transplantation;\n2. Postoperative recipients capable of understanding and providing written informed consent, and willing to comply with scheduled follow-ups and sample collections as required by the study;\n3. Postoperative recipients clinically assessed as stable and eligible for routine follow-up and hematological examinations;\n4. Recipients able to undergo dynamic pulmonary function monitoring during follow-up;\n5. No planned participation in other interventional trials during the study period that may impact immune function or pulmonary function;\n6. Retransplant patients will be considered as a new transplant event and may be included in the analysis.\n\nExclusion Criteria:\n\n1. History of active malignancy or presence of untreated malignancy within 5 years prior to transplantation;\n2. Presence of active systemic infection or significant immune rejection;\n3. Female patients who are pregnant or lactating;\n4. Any other condition deemed by the investigator to be inappropriate for inclusion .",{"count":49,"type":22},244,"2 Years","OBSERVATIONAL","By establishing a prospective, multicenter lung transplantation clinical cohort, this study aims to systematically evaluate the utility of cfDNA fragmentomics, peripheral blood single-cell sequencing, and proteomics in monitoring and predicting graft dysfunction after lung transplantation, and to develop a multi-omics predictive model for early identification, dynamic monitoring, and mechanistic investigation of acute lung allograft dysfunction (ALAD) and chronic lung allograft dysfunction (CLAD).",[54],"Lung Diseases","RECRUITING","2025-11-21",{"date":58,"type":33},"2025-11-24",{"date":60,"type":33},"2025-11-01",{"date":62,"type":22},"2030-03-01",{"name":39,"class":40},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100603632","phase-2-iparomlimab-and-tuvonralimab-plus-chemotherapy-for-inducing-conversion-to-resectability-in-initially-unresectable-stage-iii-nsclc-100603632","NCT07139041","Iparomlimab and Tuvonralimab Plus Chemotherapy for Inducing Conversion to Resectability in Initially Unresectable Stage III NSCLC","Treatment Strategy of Iparomlimab and Tuvonralimab Plus Chemotherapy for Inducing Conversion to Resectability in Initially Unresectable Stage III Non-Small Cell Lung Cancer: A Single-Arm Phase II Clinical Study","Inclusion Criteria:\n\n1. Signed an informed consent form\n2. Patients aged ≥18\n3. Histologically or cytologically confirmed Stage III (AJCC 9th ed.) squamous or non-squamous NSCLC (mixed tumors classified by predominant cell type), deemed unresectable by the MDT team based on at least one of the following criteria:\n\n   1. Ipsilateral multi-station or confluent mediastinal lymph node metastasis: Imaging shows ipsilateral multi-station lymph node metastasis or confluent lymph node mass (\\>3cm diameter) or invasion of surrounding organs, making complete surgical clearance impossible.\n   2. Contralateral or supraclavicular lymph node metastasis (N3): This includes contralateral hilar and mediastinal lymph node metastasis, or ipsilateral\u002Fcontralateral supraclavicular lymph node metastasis.\n   3. Invasion of vital organs or major vessels: Anatomical tumor or lymph node invasion directly involving the heart, major vessels (e.g., aorta, main pulmonary artery), trachea, esophagus, vertebral body (\\>50% involvement), or brachial plexus.\n   4. Extensive chest wall and pleural invasion: Involvement of ribs, intercostal muscles, and chest wall soft tissues is extensive, requiring large chest wall resection that the patient's pulmonary function cannot tolerate, or impossible to clear surgically.\n   5. Special anatomical location: e.g., superior sulcus tumor (Pancoast tumor) invading vertebrae\u002Fnerve plexus, recurrent laryngeal nerve involvement causing vocal cord paralysis, tumor extent precluding R0 resection.\n   6. Patient unable to tolerate lobectomy or pneumonectomy: Insufficient cardiopulmonary reserve, severe cardiovascular disease, coagulation dysfunction, or other systemic diseases precluding lobectomy or pneumonectomy.\n4. at least one measurable lesion according to RECIST 1.1 criteria\n5. ECOG PS 0-1.\n6. Pulmonary function must meet: FEV1 \\> 1.0 L and FEV1%\\> 40%\n7. appropriate organ function\n\nExclusion Criteria:\n\n1. NSCLC with small cell component identified on pathology (regardless of proportion); Histological types of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC-NOS.\n2. Known EGFR mutation or ALK rearrangement positivity (eligibility of subjects with other driver gene positivity will be determined by the project biomarker expert group).\n3. Prior systemic anti-tumor therapy or thoracic radiotherapy.",{"count":73,"type":22},69,[75],"PHASE2","This is a single-arm, multicenter Phase II clinical study designed to observe and evaluate the efficacy and safety of Iparomlimab and tuvonralimab plus chemotherapy in initially unresectable Stage III NSCLC. The study plans to enroll 69 Stage III NSCLC patients judged unresectable by a MDT team, with the R0 resection rate as the primary endpoint.\n\nAfter completing 2-4 cycles of conversion therapy, the MDT team reassesses resectability. Subjects deemed suitable for surgical resection undergo surgery within 6 weeks after the last dose of conversion therapy. Subjects deemed unsuitable for surgery receive radical chemoradiotherapy, starting within 6 weeks after the last conversion therapy dose. Subjects unsuitable for both surgery and chemoradiotherapy will have their subsequent treatment decided by the project team.\n\nAdjuvant therapy consists of Iparomlimab and tuvonralimab monotherapy (Q3W) for up to 16 cycles.",[78],"NSCLC (Non-small-cell Lung Cancer)",[80],"Iparomlimab and tuvonralimab;Conversion;Non-Small Cell Lung Cancer","2025-08-18",{"date":83,"type":33},"2025-08-24",{"date":85,"type":22},"2025-10",{"date":87,"type":22},"2029-06",{"name":39,"class":40},""]