[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-induced-lung-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-induced-lung-injury":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,90,117,149],{"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":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100622827","phase-2-pirfenidone-capsules-in-the-treatment-of-radiation-induced-lung-injury-with-or-without-immune-pneumonia-100622827",false,"NCT07388680","Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II\u002FIII Clinical Trial on the Efficacy and Safety of Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune-related Pneumonia","Inclusion Criteria:\n\n* The subjects must meet all the following inclusion criteria to be enrolled in this study:\n* Voluntary signing of the informed consent form, and being capable of understanding and signing the informed consent form before the study.\n* Age 18 to 75 years (inclusive of 18 and 75), with no gender restrictions.\n* Malignant tumors diagnosed by pathological histology\u002Fcytology, and having received radiotherapy to the chest.\n* According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 standard, diagnosed by the investigator as clinical RILI grade 2-3 with or without CIP. For those with CIP, the investigator determines that only hormone treatment is required.\n* At the time of enrollment, 40% ≤ DLCO as a percentage of the predicted value \\\u003C 80% (mild to moderate lung diffusion function impairment).\n* The course of radiation-induced lung injury is less than 2 months.\n* If receiving radiation-induced lung injury-related treatment (including glucocorticoids, antibiotics, etc.) at the time of enrollment, the types and doses of medication must remain stable within 2 weeks before enrollment, and the hormone medication does not exceed 4 weeks.\n* At the time of enrollment, the investigator assesses that the subjects can take oral administration of the investigational drug.\n* Eastern Cooperative Oncology Group score (ECOG) 0-2.\n* Expected survival period ≥ 6 months.\n* The functional level of major organs meets the following standards:\n\n  1. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 75 × 109\u002FL or hemoglobin (Hb) ≥ 90 g\u002FL;\n  2. Biochemical examination: Total bilirubin (TBIL), blood urea nitrogen (BUN), and creatinine (Cr) ≤ 1.5 upper limit of normal value (ULN), or creatinine clearance rate ≥ 50 mL\u002Fmin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.0 ULN.\n\n     * Creatinine clearance rate = \\[(140 - age) × weight (kg)\\] \u002F \\[0.818 × Scr (umol\u002FL)\\] (for females × 0.85)\n* For all fertile women, the serum pregnancy test within 7 days before the first administration must be negative, and fertile male and female subjects must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) with their partners during the entire study period and at least 6 months after the last use of the investigational drug.\n\nExclusion Criteria:\n\n* Subjects with Child-Pugh grade C at the time of enrollment or with severe liver diseases such as liver failure, hepatic encephalopathy, etc.\n* Subjects who have had Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug eruption with eosinophilia and systemic symptoms (DRESS), or severe skin diseases in the past or currently;\n* Subjects who have other diseases that the investigator deems unsuitable for participation in this study during the screening process.\n* Subjects with active untreated brain metastases or meningeal metastases; for subjects with treated central nervous system (CNS) metastases, if the symptoms are controlled for at least 4 weeks, they are eligible for enrollment;\n* Subjects who have a second malignancy that requires concurrent systemic cytotoxic chemotherapy, investigational treatment or biological therapy (such as anti-cytotoxic T lymphocyte-associated protein 4 \\[CTLA4\\] or human epidermal growth factor receptor 2 \\[HER2\\] monoclonal antibodies), but are allowed to enroll if they have a second malignancy that only requires hormone therapy (such as gonadotropin-releasing hormone \\[LHRH\\] agonists, tamoxifen, etc.);\n* Subjects with a history of human immunodeficiency virus (HIV) infection, or positive HIV antibodies or suspected HIV infection.\n* Subjects who cannot discontinue tetracycline antibiotics (such as doxycycline, minocycline, etc.) within 14 days before screening or during the study.\n* Subjects who the investigator deems unable to follow the testing procedures (such as being unable to tolerate the interruption of assisted oxygen supply during pulmonary function tests).\n* Subjects who have used or are to use drugs that may have preventive and\u002For therapeutic effects on radiation pneumonitis within 1 month before screening or during the study, such as pentoxifylline, angiotensin-converting enzyme inhibitors, berberine, ursolic acid, statins, nicorandil, stem cells, interferon-γ, penicillamine, etc.;\n* Subjects who have used nintedanib or high-dose acetylcysteine within 1 month before randomization;\n* Subjects who have used known or judged by the investigator to be beneficial to lung injury Chinese herbal medicines or other substances during the 1 month before randomization;\n* Subjects who have received or been exposed to live vaccines or attenuated live vaccines or plan to receive live vaccines or attenuated live vaccines (except anti-tumor treatment live vaccines) during the study;\n* Subjects who have used drugs that are strong inhibitors or inducers of cytochrome CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 within 1 month before screening or during the study;\n* Female subjects who are breastfeeding at the time of screening or male subjects whose partner is planning to get pregnant during the study.\n* Subjects with known mental disorders that may affect the study assessment or with poor compliance.\n* Subjects who are allergic to any active ingredients of this drug or its excipients (such as lactose) or lactose intolerant.\n* Subjects who had severe trauma or received surgery within 1 month before screening or during the study, or who plan to undergo surgery during the study.\n* Subjects who, according to the investigator's judgment, have other serious systemic diseases or laboratory test abnormalities or other reasons that make them unsuitable for participating in this clinical trial.\n* Subjects who plan to participate in other drug clinical trials during the study.","ALL","18 Years","75 Years",{"count":20,"type":21},298,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however, this approach yields limited improvement in diffusing capacity or ventilatory function, and its ability to prevent radiation-induced pulmonary fibrosis (RPF) remains undefined. Corticosteroids also remain the mainstay of CIP therapy. Pirfenidone, a potent cytokine inhibitor, attenuates fibroblast activity by reducing production of transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), thereby suppressing fibroblast proliferation and extracellular-matrix collagen synthesis. Pre-clinical efficacy studies have demonstrated robust anti-inflammatory, anti-oxidant, and anti-fibrotic effects in the lung.Because RILI and pneumonitis arising from combined radio-immunotherapy are often indistinguishable in clinical practice, and because both share pathogenetic features with idiopathic pulmonary fibrosis (IPF), the investigators initiated this phase II\u002FIII trial to address the unmet medical need for effective therapy. Building on prior pre-clinical and clinical data, the study aims to establish the optimal dose of pirfenidone capsules for RILI with or without concomitant CIP and to confirm efficacy and safety.Phase II (dose-finding): The study consists of a screening period (Day -28 to Day -1), a 168-day treatment-observation period (Day 1-Day 168), a safety follow-up (28 ± 7 days after the last dose), and subsequent disease-progression and survival follow-up. Ninety subjects with RILI, with or without CIP, who meet all eligibility criteria will be randomly assigned 1:1:1 to low-dose pirfenidone (400 mg TID), high-dose pirfenidone (600 mg TID), or matching placebo.Phase III (confirmatory): The dose of pirfenidone capsules for phase III will be determined jointly by the sponsor and investigators based on accumulated efficacy and safety data. The trial structure mirrors phase II: screening (Day -28 to Day -1), 168-day treatment-observation (Day 1-Day 168), safety follow-up (28 ± 7 days after the last dose), and disease-progression and survival follow-up. Eligible subjects with RILI ± CIP will be randomized 1:1 to receive either pirfenidone capsules (400 mg or 600 mg TID, taken with meals) or identical placebo. After completion of the 28-day post-treatment follow-up, all phase III participants will enter an extension phase for long-term survival assessment every 3 months (± 7 days).This trial will investigate the progression-free survival (PFS) and overall survival (OS) associated with pirfenidone capsules in patients with Grade 2 and 3 radiation-induced lung injury (RILI), with or without chemotherapy-induced pneumonitis (CIP).",[28,29],"Radiation-induced Lung Injury","Immune-related Pneumonia",[31,32,33,34,35],"Radiation-induced lung injury","Immune-related pneumonia","RILI","CIP","Pirfenidone","RECRUITING","2026-04-19",{"date":39,"type":40},"2026-04-22","ACTUAL",{"date":42,"type":40},"2026-03-26",{"date":44,"type":21},"2026-12-30",{"name":46,"class":47},"Beijing Continent Pharmaceutical Co, Ltd.","INDUSTRY",36,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100568990","incentive-spirometry-to-improve-outcomes-in-lung-cancer-patients-undergoing-concurrent-chemotherapy-and-radiation-therapy-100568990","NCT06688422","Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy","Incentive Spirometry for Respiratory Enhancement Pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy","INSPIRE-CRT","Inclusion Criteria:\n\n* Confirmed diagnosis of advanced non-small-cell lung cancer\n* Performance status (ECOG 0-1)\n* Eligible for concurrent chemotherapy and radiation\n* 18 years or older\n\nExclusion Criteria:\n\n* Previous lung or thoracic surgery\n* Enrollment in another pulmonary intervention trial\n* Home oxygen usage prior to enrolment\n* Radiological evidence of pleural effusion, pneumothorax, bullous emphysema, - or pneumonitis on staging imaging\n* Presence of active respiratory tract infection\n* Uncontrolled nausea and vomiting\n* Prior exposure to drugs such as amiodarone, bleomycin, or immunotherapy\n* Inability or unwillingness of individual to give written informed consent",{"count":58,"type":21},100,[60],"NA","The goal of this clinical trial is to learn if using an incentive spirometer can reduce lung problems in people with advanced lung cancer who are receiving chemotherapy and radiation therapy. The main questions the study aims to answer are:\n\nDoes using an incentive spirometer lower the chances of developing lung inflammation (pneumonitis)? Does it improve overall survival and quality of life?\n\nParticipants will:\n\nUse an incentive spirometer, a device that helps with deep breathing, 10 times every hour while awake.\n\nContinue using the spirometer daily during treatment and for up to three months after treatment.\n\nComplete quality of life assessments at the start of the study and at 3, 6, and 12 months.\n\nResearchers will compare the results to see if the incentive spirometer helps reduce lung problems and improves participants\\' well-being during and after their cancer treatment.",[63,64,65,66,67],"Lung Cancer","Pneumonitis","Radiation-Induced Lung Injury","Immunotherapy-Induced Pneumonitis","Non-Small-Cell Lung Cancer (NSCLC)",[69,70,71,72,73,74,75,76,77,78],"Incentive Spirometry","Chemotherapy","Radiation Therapy","Quality of Life (QoL)","Respiratory Complications","Advanced Lung Cancer","Concurrent Chemoradiotherapy","Pulmonary Toxicity","Immunotherapy Maintenance","Lung Function","2026-04-13",{"date":81,"type":40},"2026-04-15",{"date":83,"type":40},"2024-12-01",{"date":85,"type":21},"2026-12",{"name":87,"class":88},"The Cooper Health System","OTHER",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":89},"100399750","phase-2-evaluation-of-pet-probe-68gacbp8-in-the-detection-of-radiation-induced-tissue-injury-100399750","NCT04485286","Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury","Inclusion Criteria for lung cancer subjects:\n\n* Eligible patients will be those harboring locally advanced clinical stage I-III NSCLC who are not eligible for surgical resection, or those with stage IIIa NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection.\n* Age greater than 18 years\n* Have the ability to give written informed consent.\n* No tobacco use within the prior 6 months.\n\nInclusion Criteria for pancreatic cancer subjects:\n\n* Age ≥ 18 years.\n* Life expectancy of greater than 3 months.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Histologically or cytologically confirmed diagnosis of PDAC.\n* Tumor should be confirmed with imaging based on the standard-of-care baseline abdominal CT performed within 1 month before study visit 1.\n* Core samples for initial diagnosis must be available at the Department of Pathology at Massachusetts General Hospital.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational imaging and standard treatment regimen are eligible for this trial.\n* Scheduled study visit 1 within 1 month prior to starting neoadjuvant chemoradiotherapy (CRT)\n* Subjects undergo neoadjuvant chemotherapy followed by radiotherapy (CRT) as part of their standard clinical care and based on institutional standards.\n* Scheduled surgical pancreas resection within 1 month after post-CRT study visit.\n* Subjects are required to undergo pre-surgical CT of abdomen within 1 month after completion of standard neoadjuvant CRT as part of routine clinical work-up.\n\nExclusion Criteria for lung cancer subjects:\n\n* Electrical implants such as cardiac pacemaker or perfusion pump\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;\n* Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);\n* Claustrophobic reactions;\n* Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);\n* Unable to lie comfortably on a bed inside the MR-PET;\n* Body weight of \\> 300 lbs (weight limit of the MRI table);\n* Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and\u002For during study procedures);\n* Known history of pulmonary disease (Except lung cancer or smoking related lung disease,)\n* Pneumonia or other acute respiratory illness within 6 weeks of study entry, pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics\n\nExclusion Criteria for pancreatic cancer subjects:\n\n* History of radiotherapy to the upper abdomen in the past.\n* History of reaction to MRI contrast (Gadoterate meglumine)\n* Clinical or imaging diagnosis of acute pancreatitis within 6 weeks prior to study visit\n* Participants with uncontrolled intercurrent illness or if determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening and\u002For during study).\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Electrical implants such as cardiac pacemaker or perfusion pump;\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;\n* eGFR of less than 30 mL\u002Fmin\u002F1.73 m2 within the past 90 days;\n* Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential at each PET\u002FMRI study visit;\n* Claustrophobic reactions;\n* Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);\n* Unable to lie comfortably on a bed inside the MR-PET;\n* BMI \\> 33 (limit of the PET-MRI table)","80 Years",{"count":98,"type":21},72,[24],"The goal of this study is to investigate the efficacy of \\[68Ga\\]CBP8 to detect collagen deposition in radiation induced tissue injury.",[63,102,103,104],"Radiation Fibrosis","Radiation Induced Lung Injury","Pancreas Cancer",[106,107],"fibrosis","positron emission tomography","2026-02-25",{"date":110,"type":40},"2026-02-27",{"date":112,"type":40},"2020-07-19",{"date":114,"type":21},"2027-07",{"name":116,"class":88},"Massachusetts General Hospital",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":89},"100619055","functional-lung-avoidance-radiotherapy-guided-by-4dct-pulmonary-ventilation-function-imaging-a-prospective-single-arm-clinical-study-100619055","NCT07339644","Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study","4DCT-FLAR","Inclusion Criteria:\n\n* Age 18 to 85 years (inclusive); any sex.\n* Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).\n* Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT\u002FVMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.\n* Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.\n* No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.\n* Able to comply with treatment and follow-up assessments.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.\n* Age \\\u003C18 or \\>85 years.\n* Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).\n* Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.\n* Concurrent other active\u002Fadvanced malignancy requiring priority treatment that would confound study outcomes.\n* Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.\n* Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and\u002For scheduled follow-up.\n* Inadequate 4DCT image quality or inability to generate\u002Fvalidate the 4DCT ventilation map required for functional-lung-guided planning.\n* Any other condition deemed unsuitable by the investigators in the interest of participant safety.","85 Years",{"count":58,"type":21},[60],"This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy.\n\nAll participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison.\n\nThe primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.",[129,130,28],"Lung Cancer (Including Metastatic Cancer)","Radiation Pneumonitis",[132,133,134,135,136,137,138,139],"Functional lung avoidance radiotherapy","4DCT ventilation imaging","Functional lung imaging (FLI)","Dose-volume histogram (DVH)","High-function lung","Radiotherapy planning optimization","Radiation pneumonitis","Pulmonary function","2026-02-05",{"date":142,"type":40},"2026-02-09",{"date":144,"type":40},"2025-10-24",{"date":146,"type":21},"2027-12-24",{"name":148,"class":88},"The Second Affiliated Hospital of Chongqing Medical University",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100606584","early-phase-1-study-on-safety-and-efficacy-of-ucb-mncs-for-radiation-induced-lung-injury-100606584","NCT07177456","Study on Safety and Efficacy of UCB-MNCs for Radiation-induced Lung Injury","Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury","Inclusion Criteria:\n\n1. Ages 18-75 years,with no restriction on gender;\n2. History of chest radiotherapy;\n3. Diagnosed with grade 2-3 radiation-induced lung injury according to CTCAE 4.0 classification criteria in \"Diagnosis and Treatment of Radiation-induced Lung Injury\";\n4. Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;\n5. Well-controlled tumor for ≥3 months;\n6. No significant liver or kidney dysfunction: ALT, AST ≤ 3 times the upper limit of normal, serum Cr and BUN ≤ 2 times the upper limit of normal;\n7. Expected survival ≥ 3 months;\n8. Informed consent signed voluntarily by the patient;\n9. Willing and able to receive treatment and follow-up as required by the protocol, and able to comply with basic treatment as directed by the physician.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg);\n2. Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;\n3. ECOG score ≥2;\n4. Currently participating in or participated in other clinical trials within 4 weeks;\n5. History of allergies or known allergy to the study preparation;\n6. Patients with psychiatric disorders who cannot cooperate with treatment; (7) Pregnant or lactating women.",{"count":157,"type":21},10,[159],"EARLY_PHASE1","This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .",[28],"NOT_YET_RECRUITING","2025-09-16",{"date":165,"type":40},"2025-09-17",{"date":167,"type":21},"2025-10-01",{"date":169,"type":21},"2026-12-31",{"name":171,"class":88},"Zhejiang Cancer Hospital"]