[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Seventh Medical Center of PLA General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628199","phase-2-neoadjuvant-chemoradiotherapy-plus-tislelizumab-with-or-without-probio-m9-in-pmmrmss-locally-advanced-rectal-cancer-100628199",false,"NCT07458529","Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Rectal Cancer","Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)","NCRIT-PM9","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Biopsy-proven rectal adenocarcinoma\n* Distal tumor margin within 10 cm of the anal verge\n* No distant metastasis\n* Clinical stage II or III based on MRI (T4b excluded)\n* Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)\n* Willing and able to comply with the study protocol\n* Willing to provide blood and tissue specimens for research purposes\n* No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)\n* No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)\n* No significant dysfunction of major organs (heart, lung, liver, kidney)\n* No jaundice or gastrointestinal obstruction\n* No acute or ongoing infection\n* Adequate hematologic and biochemical function including:\n\n  * Neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Hemoglobin ≥ 80 g\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Serum creatinine ≤ 1.5 × ULN\n  * Total bilirubin ≤ 1.5 × ULN\n  * ALT and AST ≤ 2.5 × ULN\n* No social or psychiatric disorders that may interfere with study participation\n* Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History of multiple primary cancers or concomitant malignant tumors other than rectal cancer\n* Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years\n* History of recent major surgery\n* Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)\n* Uncontrolled or severe concomitant diseases of any kind\n* Known allergy or hypersensitivity to any components of the study drugs\n* Estimated life expectancy ≤ 5 years due to any cause\n* Planned or prior organ or bone marrow transplantation\n* Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment\n* History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)\n* Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)\n* Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).",[27,28,29,30,31,32],"Rectal Cancer, Adenocarcinoma","Neoadjuvant Therapy","Immunotherapy","Probio-M9","Tislelizumab","Randomized",[30,34,35],"tislelizumab","locally advanced rectal cancer","RECRUITING","2026-03-08",{"date":39,"type":40},"2026-03-10","ACTUAL",{"date":42,"type":40},"2026-02-10",{"date":44,"type":21},"2030-12-01",{"name":46,"class":47},"Seventh Medical Center of PLA General Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100544492","prone-position-during-ecmo-in-pediatric-patients-with-severe-ards-100544492","NCT06369584","Prone Position During ECMO in Pediatric Patients With Severe ARDS","Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study","PEPAD","Inclusion Criteria:\n\n* Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.\n* Informed consent obtained from the child's direct\u002Flegal guardian\n\nExclusion Criteria:\n\n1. Age \\\u003C 1 month or \\> 18 years old.\n2. ECMO initiated for more than 48 hours.\n3. Children who have undergone cardiopulmonary resuscitation (CPR) for more than 10 minutes before ECMO initiation without restoration of spontaneous circulation, or children undergoing extracorporeal cardiopulmonary resuscitation (ECPR).\n4. Presence of irreversible brain injury or intracranial hypertension.\n5. Children with irreversible lung disease awaiting lung transplantation.\n6. Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).\n7. Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.\n8. Other contraindications for performing percutaneous cannulation.\n9. Liver failure.\n10. Burn area \\>20% body surface area (BSA).","1 Month",{"count":59,"type":21},7,[61],"NA","In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).\n\nIn 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.\n\nECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P\u002FF\\\u003C80mmHg or Oxygen Index (OI) \\>40 for over 4 hours or OI \\>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury.",[64,65],"Pediatric Acute Respiratory Distress Syndrome","Extracorporeal Membrane Oxygenation",[67,68,69],"Extracorporeal Membrane oxygenation","pediatric acute respiratory distress syndrome","prone position ventilation","2024-06-07",{"date":72,"type":40},"2024-06-10",{"date":74,"type":40},"2024-05-09",{"date":76,"type":21},"2025-07-01",{"name":46,"class":47},8,""]