[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sixth Affiliated Hospital, Sun Yat-sen University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":626},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,49,79,106,128,150,173,198,227,258,282,308,330,355,384,404,432,455,480,504,526,547,567,591,608],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054242","phase-2-docetaxel-oxaliplatin-and-5-fu-for-gastric-cancer-with-inoperable-malignant-bowel-obstruction-100054242",false,"NCT04840264","Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction","A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction","Inclusion Criteria:\n\n* 18-75 years of age;\n* ECOG PS ≤3;\n* pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;\n* peritoneal carcinomatosis established by imaging data or pathological evidence;\n* MBO below the Treitz ligament based on clinical grounds or radiological findings;\n* considered as inoperable MBO by two independent surgical consultants;\n* Hb≥60g\u002FL, WBC ≥4×10E9\u002FL, ANC≥2×10E9\u002FL，PLT≥100×10E9\u002FL;\n* Cr≤ Upper Normal Limit(UNL);\n* Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;\n* Written informed consent form paticipants.\n\nExclusion Criteria:\n\n* treated by a combination regimen containing all the study drugs;\n* allergy to any of the study drugs;\n* HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);\n* strangulated intestinal obstruction;\n* active gastrointestinal bleeding;\n* uncontrolled active infection;\n* unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);\n* severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);\n* mental disorders that affect clinical treatment or central nervous system diseases;\n* concomitant cerebral parenchymal or meningeal metastasis;\n* HIV infection or untreated active hepatitis;\n* bowel surgery or stenting required due to obstruction;\n* pregnant or lactating women;\n* other conditions that are not suitable for participation in the study.","ALL","18 Years","75 Years",{"count":21,"type":22},79,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.",[28,29,30],"Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Peritoneal Carcinomatosis",[32,33,34,35],"Malignant Bowel Obstruction","Docetaxel","Oxaliplatin","Fluorouracil","RECRUITING","2026-07-09",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2022-01-07",{"date":44,"type":22},"2028-06-30",{"name":46,"class":47},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100634871","real-world-study-of-il-23-inhibitors-in-active-crohns-disease-100634871","NCT07545317","Real-World Study of IL-23 Inhibitors in Active Crohn's Disease","Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study","Inclusion Criteria:\n\n1. Age 18 to 75 years\n2. Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and\u002For histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria\n3. Active Crohn's disease with a baseline Crohn's Disease Activity Index (CDAI) score of 150 to 450, and at least one of the following objective inflammatory findings: (1) Endoscopic activity within 1 month before enrollment, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \\>=6 for ileocolonic or colonic disease, or SES-CD \\>=4 for isolated ileal disease, (2) Active intestinal inflammation on bowel ultrasound, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), (3) Serum C-reactive protein (CRP) above the upper limit of normal, (4) Fecal calprotectin (FC) \\>=250 ug\u002Fg\n4. Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors\n5. Prior treatment history for the IL-23 inhibitor cohort may include biologic-naive or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted\n6. If receiving concomitant medications, doses should be stable for at least 2 to 4 weeks before enrollment, including oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid\n7. Able to understand the study procedures, provide written informed consent, and comply with follow-up and biospecimen collection requirements\n8. Additional criteria for the concurrent prospective TNF inhibitor cohort used in the nested comparative analysis: (1) Participants must be bio-naive, defined as no prior exposure to any biologic agent (including TNF inhibitors, vedolizumab, ustekinumab, etc.) or targeted small-molecule therapy (such as JAK inhibitors), (2) Participants must also meet Inclusion Criteria 1, 2, 3, 6, and 7 above, (3) Participants must be planned to initiate TNF inhibitor therapy in routine clinical practice\n\nExclusion Criteria:\n\n1. Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents\n2. Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis\n3. Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction\n4. Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe\u002Frecurrent infection history\n5. Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence\n6. Pregnancy, breastfeeding, or planned pregnancy during the study period\n7. Severe systemic disease or other condition that, in the investigator's judgment, makes participation unsuitable, including severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence\n8. Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial",{"count":57,"type":22},665,"OBSERVATIONAL","The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are:\n\n* What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?\n* What are the clinical, endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment?\n\nThis is not a head-to-head randomized study. Treatments are selected by treating physicians as part of routine clinical care. For a nested comparative analysis, bio-naive participants treated with IL-23 inhibitors will be compared with a concurrent prospective cohort of bio-naive participants treated with TNF inhibitors to evaluate comparative effectiveness and safety.\n\nParticipants will:\n\n* Receive treatment chosen by their treating physicians as part of routine clinical care, including IL-23 inhibitors or TNF inhibitors\n* Attend study follow-up visits during induction and maintenance, including assessments at baseline, Week 12 and Week 52\n* Undergo routine clinical evaluations, which may include symptom assessment, laboratory tests, endoscopy, and imaging, as available\n* Be monitored for adverse events and treatment changes during the study\n* Optionally provide blood, stool, and other available samples for exploratory biomarker, microbiome, metabolomic, and other multi-omics analyses related to treatment response",[61],"Crohn's Disease",[63,64,65,66,67,68,69,70],"Crohn's disease","IL-23 inhibitor","TNF inhibitor","Bio-naive","Real-world study","Observational cohort","Clinical remission","Endoscopic remission","2026-07-01",{"date":73,"type":40},"2026-07-02",{"date":75,"type":40},"2026-04-16",{"date":77,"type":22},"2028-08-31",{"name":46,"class":47},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100585873","phase-2-scrtmfolfox6pd-1-antibody-and-targeted-therapy-for-high-risk-pmmrmss-rectal-cancercrit-100585873","NCT06908031","SCRT+mFOLFOX6+PD-1 Antibody and Targeted Therapy for High-Risk pMMR\u002FMSS Rectal Cancer(CRIT)","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Prospective, Multicenter Phase II Study(CRIT)","CRIT","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   1. White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. Hemoglobin (HGB) ≥80 g\u002FL;\n   3. Platelets (PLT) ≥100×10\\^9\u002FL;\n   4. Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range;\n   5. Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range;\n   6. Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":88,"type":22},49,[25],"To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS\u002FBRAF Wild-Type)\u002Fbevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.",[92,93,94],"Rectal Adenocarcinoma","High-Risk Cancer","MSS",[96,97,98],"Short-Course Radiotherapy","Targeting Therapy","Immunotherapy","2026-06-30",{"date":71,"type":40},{"date":102,"type":40},"2025-04-02",{"date":104,"type":22},"2027-04-01",{"name":46,"class":47},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100635185","phase-3-scrt--chemo-targeted-immuno-neoadjuvant-therapy-for-high-risk-pmmrmss-rc-100635185","NCT07549399","SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR\u002FMSS RC","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial","CRITⅡ","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   * White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n\n     * Hemoglobin (HGB) ≥80 g\u002FL; ③Platelets (PLT) ≥100×10\\^9\u002FL; ④Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range; ⑥Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":115,"type":22},204,[117],"PHASE3","To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS\u002FBRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR\u002FMSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.",[92,93,94],[96,97,98],"2026-06-29",{"date":71,"type":40},{"date":124,"type":40},"2026-05-20",{"date":126,"type":22},"2029-04-30",{"name":46,"class":47},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":48},"100544092","phase-2-radical-concurrent-chemoradiotherapy-with-ddp5-fu-and-pd-1-antibody-for-non-metastatic-rectal-squamous-cell-carcinoma-100544092","NCT06364384","Radical Concurrent Chemoradiotherapy With DDP\u002F5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma","Radical Concurrent Chemoradiotherapy With DDP\u002F5-FU and PD-1 Antibody for Newly Diagnosed Non-metastatic Rectal Squamous Cell Carcinoma: A Multicenter, Prospective, Single Arm, Phase II Study(RICH).","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent;\n2. 18-75 years old;\n3. Patients with pathologically confirmed rectal squamous cell carcinoma;\n4. imaging to rule out distant metastases;\n5. Peripheral blood and liver and kidney function before treatment within the following allowable limits (tested within 14 days before the start of treatment)\n\n   1. White blood cell (WBC) ≥ 3.0×109\u002FL or neutrophil (ANC) ≥1.5×109\u002FL;\n   2. Hemoglobin (HGB) ≥80 g\u002FL;\n   3. Platelets (PLT) ≥ 100×109\u002FL;\n   4. Hepatic transaminases (AST\u002FALT) \\\u003C 3.0 times the upper limit of the normal range;\n   5. Total bilirubin (TBIL) \\\u003C 1.5 times the upper limit of the normal range;\n   6. Creatinine (CREAT) \\\u003C 1.5 times the upper limit of the normal range.\n6. ECOG performance status score of 0-2;\n7. No history of other malignant tumors in the past.\n\nExclusion Criteria:\n\n1. Non-treatment-naïve patients who have previously received chemotherapy, radiotherapy or complete surgical resection of rectal squamous cell carcinoma;\n2. Distant metastases (M1) confirmed by whole-body CT, MR, or PET-CT (including at least the chest, abdomen, and pelvis);\n3. Previous or concurrent presence of other active malignancies (except for malignant tumors that have received curative therapy and have been disease-free for more than 3 years or carcinoma in situ that can be cured by adequate treatment);\n4. Major surgery such as laparotomy, thoracotomy, resection of organs by laparoscopic surgery or severe trauma within the past 4 weeks (the surgical incision should be completely healed before randomization);\n5. Active coronary artery disease, severe\u002Funstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to enrollment in the study;\n6. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis within the past 6 months;\n7. New York Heart Association (NYHA) Class II or above congestive heart failure;\n8. Prior receipt of any investigational drug;\n9. Pregnant or lactating women;\n10. Any medical condition that is unstable or would affect patient safety and their compliance with the study;\n11. Patients judged by the investigator to be unsuitable to participate in this clinical trial.",{"count":136,"type":22},20,[25],"The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:\n\nDoes PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.\n\nParticipants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.",[140],"Rectal Squamous Cell Carcinoma",[142,143],"PD-1","Chemoradiotherapy",{"date":71,"type":40},{"date":146,"type":40},"2024-04-12",{"date":148,"type":22},"2029-06-08",{"name":46,"class":47},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":48},"100644020","phase-2-a-multicenter-randomized-controlled-phase-ii-study-of-short-course-radiotherapy-followed-by-sequential-pd-1-inhibitor-and-folfox-chemotherapy-versus-long-course-chemoradiotherapy-for-high-risk-locally-advanced-pmmrmss-lower-rectal-adenocarcinoma-star-trial-100644020","NCT07669220","A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR\u002FMSS Lower Rectal Adenocarcinoma (STAR Trial)","STAR","Inclusion Criteria:\n\n1. Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must be obtained from the subject voluntarily, in accordance with regulatory requirements and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma.\n4. The lower edge of the rectal tumor is located below the peritoneal reflection.\n5. Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 \u002F cN2 \u002F EMVI+ \u002F MRF+ \u002F positive lateral lymph node.\n6. No clear evidence of distant metastasis prior to treatment.\n7. No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status 0-1 (Appendix 1).\n9. Peripheral blood counts and liver and renal function within the following ranges (tested within 15 days before treatment initiation):\n\n   * White blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL or absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n\n     * Hemoglobin (HGB) ≥ 80 g\u002FL; ③ Platelet count (PLT) ≥ 100 × 10⁹\u002FL; ④ Hepatic transaminases (AST\u002FALT) \\\u003C 3.0 × upper limit of normal (ULN); ⑤ Total bilirubin (TBIL) \\\u003C 1.5 × ULN; ⑥ Creatinine (CREAT) \\\u003C 1.5 × ULN.\n10. No history of other concurrent malignancies; not pregnant or lactating; effective contraceptive methods should be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists).\n2. Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment.\n3. History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways.\n4. Severe electrolyte abnormalities.\n5. Presence of gastrointestinal diseases such as active gastric or duodenal ulcer, ulcerative colitis, or unresected tumor with active bleeding; or other conditions that may cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment.\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding tendency or hemorrhagic history within 2 months; currently receiving high-dose anticoagulation therapy.\n7. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test prior to the first dose; or female participants and their partners who are unwilling to practice strict contraception during the study period.\n8. Presence of other concurrent or prior active malignancies (except for malignancies that have been curatively treated with no recurrence for more than 3 years, or carcinoma in situ that can be cured by adequate treatment).\n9. Severe electrocardiogram abnormalities, or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or congestive heart failure of NYHA Class II or higher.\n10. Patients with active infection (infection causing fever \\> 38°C).\n11. Patients with poorly controlled hypercalcemia, hypertension, or diabetes mellitus.\n12. Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).\n13. Patients with mental disorders affecting clinical treatment or a history of central nervous system disease.\n14. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).\n15. Presence of any unresolved toxicity of CTCAE Grade 2 or higher resulting from prior therapy (except for anemia, alopecia, and skin pigmentation).\n16. Any medical condition that is unstable or may affect patient safety and compliance with the study.\n17. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.",{"count":158,"type":22},76,[25],"This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR\u002FMSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.",[92,162,163,98,164],"High-risk Locally Advanced","Short-course Radiotherapy (SCRT)","FOLFOX","2026-06-21",{"date":167,"type":40},"2026-06-25",{"date":169,"type":40},"2026-01-01",{"date":171,"type":22},"2028-01-01",{"name":46,"class":47},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":48},"100555278","phase-2-perioperative-oxaliplatin-with-s-1-combined-h-pylori-eradication-in-the-management-of-locally-advanced-gastric-cancer-100555278","NCT06510010","Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer","Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Adenocarcinoma of the Gastric and Oesophagogastric Junction: an Open-label, Prospective, Multicenter, Randomised, Phase 2 Trial.","Inclusion Criteria:\n\n1. have been fully informed about the study and voluntarily signed the informed consent form (ICF);\n2. Gastroscopy pathology confirmed locally advanced adenocarcinoma of the gastric and oesophagogastric junction (Siewert type I-III);\n3. Clinical (enhanced CT, enhanced MRI, or PET-CT) staging at the time of diagnosis: cT3\u002F4a Nx or T2 N2\u002F3, M0 (The American Joint Committee on Cancer 8th edition):\n4. The present H. Pylori infection at the time of diagnosis is determined by one of the following 3 items: ① Positive gastric mucosal tissue rapid urease test (RUT), tissue section staining, or bacterial culture for any of the 3 items. Positive 13C or 14C-urea breath test (UBT). ③ Positive helicobacter pylori stool antigen (HpSA) tests (clinically validated monoclonal antibody method). Positive serum H. Pylori antibody test (clinically proven reagent with high accuracy) suggests previous infection, and those who have never been treated can be considered as having current infection;\n5. Sex is not limited and age is 18-75 years old;\n6. Eastern Cooperative Oncology Group (ECOG) score 0-1;\n7. Organ function permits major abdominal surgery;\n8. Expected survival ≥ 6 months;\n9. Laboratory test values must meet the following criteria within 7 days prior to enrollment:\n\n   1. whole-body cryotherapy\u002Fcryostimulation (WBC) \\> 4.0 × 10\\^9\u002FL and \\\u003C 15 × 10\\^9\u002FL, ANC \\> 1.5 × 10\\^9\u002FL, Hb ≥ 75 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL;\n   2. Serum bilirubin ≤ 1.5 x high limit of normal, aspartate transaminase (AST), alanine aminotransferase (ALT) ≤ 2.5 x high limit of normal;\n   3. Creatinine ≤ 1.5 x high limit of normal or creatinine clearance rate \\> 60 ml\u002Fmin;\n   4. international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × Upper limit of normal ( ULN ) only for subjects not receiving anticoagulation; subjects receiving anticoagulation should be on a stable dose;\n10. Ability to cooperate with the appropriate endoscopic, laboratory and imaging tests for this protocol;\n11. Females of childbearing potential (including females who are menopausal due to chemo-menopause or other medical reasons) must agree to use contraception for a period of at least 6 months from the time of signing the Informed Consent Form to at least 6 months after the last dose of study treatment or concomitant chemotherapy, whichever is later. Females must also agree to refrain from breastfeeding for a period of at least 6 months from the time of signing the informed consent to the time of the last administration of the study drug or concomitant chemotherapy, whichever is later; males must agree to use contraception for a period of at least 6 months from the time of administration of the test drug to the time of the last administration of the test drug or concomitant chemotherapy, whichever is later.\n\nExclusion Criteria:\n\n1. Stage IV or unresectable gastric or gastroesophageal junction cancer as determined by the investigator;\n2. Other active malignancies within 5 years or concurrently.\n3. Patients who are preparing for or have previously received organ or bone marrow transplantation;\n4. Myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated by the Fridericia formula);\n5. Presence of New York Heart Association (NYHA) class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) \\\u003C 50%;\n6. Presence of active pulmonary tuberculosis by history or CT, or patients with a history of active pulmonary tuberculosis within 1 year prior to enrollment, or patients with a history of active pulmonary tuberculosis more than 1 year prior but without regular treatment;\n7. Presence of a known active or suspected autoimmune disease. The exception is those who are in a stable state of that disease at the time of enrollment (not requiring systemic immunosuppression therapy);\n8. Received a live vaccine within 28 days prior to the first dose; except inactivated viral vaccines for seasonal influenza;\n9. Patients requiring treatment with systemic corticosteroids (\\> 10 mg\u002Fday prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to first dose or during the study period. However, enrollment is permitted if patients are allowed to be treated with topical topical or inhaled steroids, or adrenal hormone replacement therapy at doses ≤ 10 mg\u002Fday prednisone efficacy dose in the absence of active autoimmune disease;\n10. Undergoing treatment in another clinical study or scheduled to begin treatment in this study less than 14 days from the end of treatment in the previous clinical study;\n11. Known history of severe allergy to any study drug excipients;\n12. known history of psychotropic pharmaceuticals abuse or drug addiction; patients who have stopped drinking alcohol can be enrolled;\n13. Presence of patients with conditions that may increase the risk of study medication, or other severe, acute and chronic medical conditions that, in the judgment of the investigator, make participation in a clinical study unsuitable.",{"count":181,"type":22},180,[25],"This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction (cT3\u002F4a Nx or T2 N2\u002F3, M0) , assessing their values and advantages.",[185],"Chemotherapy Effect",[187,188,189],"H. Pylori Eradication","Perioperative chemotherapy","Locally Advanced Gastric Cancer","2026-06-08",{"date":192,"type":40},"2026-06-10",{"date":194,"type":40},"2024-12-31",{"date":196,"type":22},"2027-07-31",{"name":46,"class":47},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100618233","effect-of-titrated-administration-of-ciprofol-on-perioperative-hypotension-in-elderly-patients-undergoing-laparoscopic-abdominal-surgery-a-randomized-controlled-trial-100618233","NCT07328958","Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial","Effect of Titrated Administration of Ciprofol Combined With Remifentanil on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial","TAPH","Inclusion Criteria:\n\n* Age ≥65 years, scheduled for elective laparoscopic abdominal surgery\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Requirement for invasive arterial blood pressure monitoring\n\nExclusion Criteria:\n\n* Participation in other clinical trials that may interfere with the intervention or outcomes of this study\n* Severe hepatic or renal disease (GFR ≤30 mL\u002Fmin\u002F1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function)\n* Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg)\n* Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative\u002Fanalgesic medications;\n* Known allergy to drugs used in this study\n* Requirement for continuous vasopressor infusion before surgery, or intraoperative need for prolonged hemodynamic manipulation due to surgical factors\n* Anticipated blood loss \\>15% of estimated blood volume\n* Expected surgical duration \\\u003C1 hours or \\>6 hours\n* Expected postoperative hospital stay \\\u003C72 hours","65 Years",{"count":208,"type":22},500,[210],"NA","Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. These factors not only increase the risk of adverse perioperative outcomes but also heighten sensitivity to anesthetic agents, making elderly patients particularly susceptible to anesthesia-related complications, especially hypotension. Consequently, optimizing anesthesia strategies for this high-risk population has become a critical goal in perioperative management.\n\nTitrated anesthesia, which individualizes anesthetic drug delivery based on patient response to achieve predefined endpoints, offers a potential approach to mitigating anesthetic risks. Ciprofol, a novel intravenous anesthetic, has been associated with less hemodynamic suppression compared with traditional agents; however, higher single doses may still predispose patients to hypotension. Remifentanil, an ultra-short-acting opioid, exerts significant cardiovascular depressive effects, further contributing to perioperative hypotension.\n\nIt is hypothesized that titrated administration of anesthetic agents during both the induction and maintenance phases, compared with conventional fixed-dose protocols, may reduce the incidence of perioperative hypotension in elderly patients.",[213],"Hypotension During Surgery",[215,216,217,218],"elderly","general anesthesia","titrated","ciprofol","2026-06-07",{"date":192,"type":40},{"date":222,"type":40},"2026-01-16",{"date":224,"type":22},"2027-01-30",{"name":46,"class":47},2,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":48},"100632169","phase-4-tnfi-plus-low-dose-upadacitinib-vs-tnfi-intensification-in-crohns-disease-with-suboptimal-response-100632169","NCT07510191","TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response","Efficacy and Safety of Standard-Dose TNF Inhibitor Plus Low-Dose Upadacitinib Versus TNF Inhibitor Intensification for Crohn's Disease With Suboptimal Response to Standard-Dose TNF Inhibitors: A Multicenter, Randomized, Controlled Trial","CD","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age 18-65 years, regardless of sex.\n2. Established diagnosis of Crohn's disease (CD) based on a comprehensive assessment including clinical manifestations, imaging, endoscopy, histopathology, and other relevant evaluations, and meeting currently accepted domestic and international diagnostic criteria.\n3. Prior exposure to TNFα inhibitors (including infliximab, adalimumab, or its biosimilars) for at least 12 weeks, and currently receiving a standard-dose treatment regimen. After comprehensive evaluation by the investigators, the participant is considered to have partial response to TNFα inhibitor therapy with residual room for optimization. This is defined as failure to achieve the prespecified treatment target after standard induction and\u002For maintenance therapy, while still being considered by the investigator to have potential for further optimization. Eligible participants should meet either of the following: (1)Loss of response (LOR): The participant previously achieved clinical remission and\u002For objective improvement after TNFα inhibitor treatment, but subsequently developed recurrent disease activity during the maintenance phase. Based on the prior response trajectory, current objective evidence of disease activity, treatment adherence, and available reactive therapeutic drug monitoring (TDM) results, the investigator judges that the participant has not developed complete pharmacodynamic failure to TNFi, and still has room for further therapeutic optimization. (2)Primary inadequate response: After completion of standard induction therapy, the participant achieved some but insufficient improvement compared with pretreatment baseline, defined as meeting at least one of the following: ①CDAI decrease of ≥100 points, but CDAI remains ≥150, ②SES-CD decrease of ≥50%, but active ulcerative lesions persist or endoscopic remission has not been achieved, ③CRP and\u002For FCP decrease of ≥50%, but inflammatory markers have not normalized (e.g., FCP ≥250 μg\u002Fg), ④Based on a comprehensive assessment of symptoms, endoscopy, inflammatory biomarkers, and imaging, the investigator determines that the participant has achieved partial response to TNFi but has not reached the anticipated treatment target, with further room for optimization.\n4. Active Crohn's disease with objective evidence of active inflammation, defined as meeting all of the following: 150 ≤ CDAI \\\u003C 450; at least one of the following objective indicators of active inflammation: (1)Endoscopy showing active ulcerative lesions, (2)Elevated inflammatory markers such as C-reactive protein (CRP), (3)Fecal calprotectin (FCP) ≥250 μg\u002Fg, (4)Imaging evidence of active intestinal inflammation, such as CTE, MRE, or intestinal ultrasound.\n5. At enrollment, the participant must simultaneously meet both requirements:\n\n   Partial response to TNFα inhibitor therapy with residual room for optimization, and\n6. Objective evidence of active inflammation at the current active stage of CD. Baseline TDM and pharmacokinetic assessment are feasible at enrollment, and relevant results may be used for baseline stratification, efficacy analysis, and exploratory research.\n7. The participant fully understands the study objectives, procedures, and potential risks, voluntarily agrees to participate, and has signed the written informed consent form.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. No improvement at all after adequate induction therapy with a TNFα inhibitor, with investigator judgment indicating clear mechanistic non-response and minimal likelihood of benefit from further optimization.\n2. Documented immunogenic clearance confirmed by therapeutic drug monitoring (TDM), defined as positive anti-drug antibodies against a TNFα inhibitor with extremely low or undetectable trough drug levels, and judged by the investigator to be unsuitable for continued treatment with the original TNFα inhibitor.\n3. Current symptoms are judged, after comprehensive evaluation, to be caused primarily by non-inflammatory factors, with no objective evidence of active inflammation, such as irritable bowel syndrome, bile acid diarrhea, small intestinal bacterial overgrowth, or other non-inflammatory causes.\n4. Prior exposure to JAK inhibitors (including but not limited to upadacitinib), known hypersensitivity to any component of the investigational treatment, or other clear contraindications to study treatment.\n5. Presence of severe intestinal complications rendering the participant unsuitable for this study, including but not limited to inadequately controlled active intra-abdominal abscess, intestinal perforation, severe stricture requiring urgent surgical intervention, or severe active intestinal fistula.\n6. Major bowel resection, stoma creation, or other major abdominal surgery within 3 months prior to enrollment, if judged by the investigator to affect efficacy assessment or safety evaluation.\n7. Active infection or high risk of severe infection, including but not limited to active tuberculosis, uncontrolled serious bacterial\u002Ffungal\u002Fviral infection, active herpes zoster, HBV reactivation, HIV infection, or other clinically significant immunodeficiency states.\n8. Severe dysfunction of major organs, such as significant hepatic impairment, severe renal insufficiency, severe cardiac insufficiency, or other serious underlying diseases judged by the investigator to make participation inappropriate.\n9. History of gastrointestinal malignancy, or presence of any other malignant disease that may significantly affect study safety or efficacy assessment.\n10. Pregnant or breastfeeding women, or women planning pregnancy who are unwilling to use effective contraception during the study period.\n11. Severe psychiatric or neurologic disorders that may impair the ability to provide informed consent, adhere to treatment, or complete study follow-up.\n12. Participation in another interventional clinical study within 30 days prior to enrollment, where the prior intervention may affect the efficacy or safety assessment of this study.\n13. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment in this study.",{"count":236,"type":22},312,[238],"PHASE4","This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment. Participants will be randomly assigned in a 1:1 ratio to either continue standard-dose TNFi with oral upadacitinib 15 mg once daily, or receive TNFi dose intensification according to the protocol. Clinical assessments will be performed at baseline and during follow-up, with the primary endpoint assessed at Week 14. The primary outcome is the proportion of participants achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score \\\u003C150 at Week 14. Secondary outcomes include clinical response, endoscopic response and remission, changes in inflammatory biomarkers such as C-reactive protein and fecal calprotectin, quality of life, and safety outcomes including adverse events and serious adverse events. Participants will continue follow-up after Week 14 to evaluate treatment durability and longer-term safety. This study is designed to determine whether a dual-target strategy with standard-dose TNFi plus low-dose upadacitinib provides superior short-term efficacy and acceptable safety compared with conventional TNFi intensification in Crohn's disease patients with insufficient benefit from standard-dose TNFi therapy.",[241],"Crohn Disease (CD)",[243,65,244,245,246,247,248,249],"Crohn Disease","Infliximab","Adalimumab","Upadacitinib","Dose intensification","Dual-target therapy","Multicenter randomized controlled trial","2026-06-05",{"date":252,"type":40},"2026-06-09",{"date":254,"type":40},"2026-03-01",{"date":256,"type":22},"2029-12-31",{"name":46,"class":47},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":48},"100343195","adjuvant-chemotherapy-in-clinical-local-advanced-crc-following-preoperational-therapies-and-pt0-3n0m0-diagnosis-100343195","NCT03748485","Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis","Comparing the Treatment Efficacy in Clinical Local Advanced Colorectal Cancer (cTxN1\u002F2M0) Following Preoperational Adjuvant Therapies and Pathologically Proved StageⅡ(pT0-3N0M0)With or Without Adjuvant Chemotherapy","CANWATCH","Inclusion Criteria:\n\n* preoperative clinical tumor stage III （TxN1-2M0）CRC\n* pathological proved CRC adenocarcinoma by endoscopic biopsy\n* Post operational pathological T0-3N0M0 without high risk factors of recurrence\n* Patient able to understand and sign written informed consent\n\nExclusion Criteria:\n\n* Other malignant tumors history.\n* Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).\n* Colorectal tumor extension towards abdominal wall and\u002For adjacent organ making liver R0 resection impossible immediately.\n* Non resectable lymph node metastasis.\n* American Society of Anesthesiologists (ASA) grading≥ IV and\u002For, Eastern Cooperative Oncology Group(ECOG) score≥ 2.\n* Physical or psychological dependence.\n* Pregnant or breast feeding women.\n* Not controlled pre-operational infection.\n* Enrolled in other clinical trials within 4 weeks.\n* Other clinical or laboratorial condition not recommended by investigators.",{"count":267,"type":22},650,[210],"Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.",[271,272],"Colorectal Cancer","Adjuvant Chemotherapy",[274,275],"local advanced colorectal cancer","adjuvant chemotherapy",{"date":252,"type":40},{"date":278,"type":40},"2019-04-30",{"date":280,"type":22},"2030-12-30",{"name":46,"class":47},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":297,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":48},"100606486","phase-2-clinical-trial-of-neoadjuvant-mfolfox-plus-alvenor-for-larc-patients-with-high-ywhab-expression-100606486","NCT07176182","Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression","mFOLFOX6 Combined With Citrus Flavonoid Tablets (Aimailang) as Neoadjuvant Therapy for Locally Advanced Rectal Cancer With High YWHAB Expression: A Prospective, Multi-center, Open-Label, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria\n\n1. Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination.\n2. Radiographically measurable or clinically evaluable rectal tumor lesion; clinical pathologic stage T2N+ or T3-4aAnyN, M0. Clinical staging is determined by physical examination, contrast-enhanced chest and abdominopelvic CT, and pelvic MRI. For patients with MRI contraindications, staging is performed with contrast-enhanced pelvic CT plus transrectal ultrasound. Staging adheres to the 9th AJCC TNM Staging System (Appendix 1).\n3. Pelvic MRI confirms the tumor is not adherent to the mesorectal fascia (MRF-negative), defined as a tumor-MRF distance ≥ 2 mm (tumor distance \\\u003C 2 mm is defined as MRF involvement).\n4. ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry.\n5. Age 18-75 years at the time of informed consent.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3).\n7. No prior systemic anticancer therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitors, molecular targeted agents, or endocrine therapy.\n8. Adequate organ function with screening laboratory parameters meeting the following criteria:\n\n   * White blood cell count ≥ 3 × 10⁹\u002FL\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   * Platelet count ≥ 75 × 10⁹\u002FL\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n   * Serum creatinine ≤ 1.5 × ULN\n9. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study treatment and agree to use a highly effective, medically acceptable contraceptive method (e.g., intrauterine device, combined oral contraceptives, barrier methods) throughout the study and for 3 months after the last study drug administration.\n10. Male patients with partners of childbearing potential must practice effective contraception during the study and for 3 months following the last study drug administration.\n11. The patient voluntarily provides written informed consent and is willing and able to comply with all scheduled study visits, treatment administration, laboratory assessments, and protocol-specified procedures.",{"count":290,"type":22},236,[25],"This study is a prospective, multicenter, open-label, randomized controlled Phase II clinical trial enrolling patients with locally advanced rectal cancer who tested positive for YWHAB (tyrosine 3-monooxygenase\u002Ftryptophan 5-monooxygenase-activating protein β) prior to surgery. The trial aims to evaluate the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimilang) for neoadjuvant (preoperative) treatment.\n\nTreatment Regimen 4-6 cycles preoperatively, with each cycle lasting 14 days.\n\nTranslated with DeepL.com (free version)\n\nOxaliplatin: 85 mg\u002Fm² via 180-minute intravenous infusion on Day 1.\n\nLeucovorin: 400 mg\u002Fm² via 120-minute intravenous infusion on Day 1.\n\n5-Fluorouracil: 2400 mg\u002Fm² via continuous intravenous infusion over 46 hours.\n\nCitrus flavonoid tablets (Aimailang) : 500 mg orally twice times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment).\n\nKey Trial Design Features Dose Adjustments: Permitted during the trial based on patient tolerance.\n\nDiscontinuation Criteria:\n\nPatients with disease progression during neoadjuvant therapy will cease study treatment and proceed to surgery or alternative therapies per local guidelines.\n\nSurgery may be initiated early if patients cannot tolerate the planned 6 cycles of neoadjuvant therapy.\n\nPatients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.\n\nPostoperative Management:\n\nPost-treatment plans (e.g., continuation of mFOLFOX + Aimailang) are determined by the investigator.\n\nControl Group Restriction: Patients in the control arm are not permitted to self-administer citrus flavonoid tablets (Aimailang) during the trial. Any requirement for this medication must be discussed with the treating physician, who will decide on alternative therapies or trial withdrawal.",[294,295,296],"Rectal Cancer Patients","Rectal Cancer Stage II","Rectal Cancer Stage III",[298,299,300],"Neoadjuvant Therapy","mFOLFOX6","Citrus Flavonoid Tablets (Aimailang)",{"date":302,"type":40},"2026-05-26",{"date":304,"type":40},"2026-03-20",{"date":306,"type":22},"2031-03-20",{"name":46,"class":47},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":322,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":48},"100639279","inhalational-versus-intravenous-anesthesia-on-postoperative-lung-injury-in-septic-patients-undergoing-surgery-100639279","NCT07601256","Inhalational Versus Intravenous Anesthesia on Postoperative Lung Injury in Septic Patients Undergoing Surgery","Inhalational Versus Intravenous Anesthesia on Lung Injury After Major Surgery in Patients With Sepsis","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosis of sepsis according to Sepsis-3.0 (highly suspected or confirmed infection with acute increase in SOFA score ≥ 2).\n3. Scheduled to undergo surgery under general aaesthesia for source control or sepsis-related operative management.\n\nExclusion Criteria:\n\n1. Already intubated prior to entering the operating room.\n2. Chronic home ventilator dependence (e.g., severe chronic obstructive pulmonary disease) before surgery.\n3. Personal or family history of malignant hyperthermia.\n4. Known allergy to ciprofol or sevoflurane.\n5. Known allergy to egg or soy products.\n6. Any contraindication to the planned anaesthetic agents.\n7. Pregnant women.",{"count":316,"type":22},480,[210],"This randomized controlled trial will compare the effects of intraoperative inhalational anesthesia versus intravenous anesthesia on postoperative lung injury in septic patients undergoing surgery. The primary goal is to determine if the choice of anesthetic technique influences the incidence or severity of this complication. Participants will be randomly assigned to one of the two anesthetic regimens during surgery. They will receive daily in-hospital assessments for lung injury and other outcomes and will be followed for clinical outcomes until 90 days after the procedure.",[320,321],"Sepsis","Lung Injury","NOT_YET_RECRUITING","2026-05-15",{"date":325,"type":40},"2026-05-22",{"date":327,"type":22},"2026-08-15",{"date":280,"type":22},{"name":46,"class":47},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":48},"100631732","exclusive-enteral-nutrition-therapy-for-active-and-complicated-crohns-disease-100631732","NCT07504510","Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease","Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study","EEN-CD","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of Crohn's disease established on the basis of overall clinical assessment, including compatible clinical history and standard endoscopic, histologic, and\u002For radiologic findings, as determined by the treating physician. Histologic confirmation at baseline is not required if endoscopy or biopsy is not feasible or clinically inappropriate because of severe disease, poor nutritional status, or intra-abdominal abscess\u002Fsepsis.\n3. Active Crohn's disease at baseline, as determined by the treating physician.\n4. Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care.\n5. Presence of malnutrition or nutritional risk and clinical indication for EEN.\n6. Patients with intestinal complications, including enteric fistula, intestinal stricture, and\u002For intra-abdominal abscess, are eligible if considered appropriate for EEN-based management by the treating physician.\n7. Ability and willingness to provide written informed consent and to comply with study assessments and follow-up for 12 weeks.\n\nOptional clarifying note:\n\nIn participants without histologic confirmation at baseline, the diagnosis may be further confirmed during follow-up when clinically feasible, including by endoscopic biopsy or surgical pathology.\n\nExclusion Criteria\n\n1. Any absolute contraindication to enteral nutrition, including but not limited to gastrointestinal perforation, uncontrolled gastrointestinal bleeding, severe hemodynamic instability\u002Fshock, or other conditions where enteral feeding is not clinically appropriate.\n2. Immediate need for emergency surgery at baseline.\n3. Inability or unwillingness to receive EEN as the sole induction therapy at baseline.\n4. Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.",{"count":339,"type":22},300,"The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as stricturing disease, enteric fistula, and intra-abdominal abscess. The main questions it aims to answer are:\n\n* What is the clinical remission rate at Week 12 in adults with active CD treated with EEN?\n* How does EEN affect clinical response, endoscopic outcomes, inflammatory markers, nutritional status, BMI, and safety during follow-up?\n\nParticipants will:\n\n* start EEN at baseline and be followed through Week 12;\n* receive EEN as the main treatment approach during the study period;\n* complete clinical, laboratory, nutritional, and safety assessments at prespecified follow-up visits;\n* undergo endoscopic assessment when endoscopy is performed as part of routine care; and\n* if clinically indicated, some participants with large intra-abdominal abscesses may receive percutaneous drainage and necessary antibiotic treatment.",[61],[343,344,345,346,347],"exclusive enteral nutrition","active Crohn's disease","enteric fistula","intestinal stricture","intra-abdominal abscess",{"date":349,"type":40},"2026-05-19",{"date":351,"type":40},"2020-06-01",{"date":353,"type":22},"2026-12-31",{"name":46,"class":47},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":371,"overallStatus":322,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":4},"100636916","revised-paravertebral-nerve-blocks-for-enhanced-recovery-after-stoma-closure-100636916","NCT07571902","Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure","Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial","r-PVB III","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.\n\nExclusion Criteria:\n\n* Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥8), sepsis, or allergy to local anesthetics.\n* Expected operative time longer than 150 minutes, or stoma reversal not being the primary surgical procedure.\n* Chronic opioid use.\n* Heart failure, liver failure, renal failure, coagulation disorders, or a history of allergy to local anesthetics.\n* Inability to comply with study procedures, including severe psychiatric illness, refusal to sign informed consent, or anticipated difficulty in completing postoperative follow-up.",{"count":364,"type":22},250,[210],"After stoma closure, pain remains an important problem affecting patient recovery. A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary ninth to eleventh intercostal level with the patient kept supine after induction of anesthesia. Rather than puncturing the classical paraspinal target near the transverse process with the patient in a prone or lateral position, the r-PVB technique is designed to exploit retrograde spread of local anesthetic from the intercostal space to the paravertebral space, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and the need for specific body positioning. The r-PVB technique addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.",[368,369,370],"Stoma Closure","Postoperative Pain","Quality of Recovery",[368,372,373,369,370,374,375],"Ileostomy Closure","Colostomy Closure","Intercostal Space Block","Paravertebral Nerve Block","2026-05-06",{"date":378,"type":40},"2026-05-11",{"date":380,"type":22},"2026-04-27",{"date":382,"type":22},"2027-12-31",{"name":46,"class":47},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":322,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":403,"locationsCount":4},"100636525","revised-paravertebral-nerve-blocks-for-enhanced-recovery-after-laparoscopic-cholecystectomy-100636525","NCT07566819","Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy","Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial","REVISED-PVB II","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease\n\nExclusion Criteria:\n\n* Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics\n* Surgeon-estimated high likelihood of conversion to open surgery\n* Chronic opioid use\n* Heart failure, liver failure, or renal failure\n* Coagulation disorders\n* History of allergy to local anesthetics\n* Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up",{"count":364,"type":22},[210],"After laparoscopic cholecystectomy, pain remains an important problem affecting patient recovery. A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary eighth or ninth intercostal level with the patient kept supine after induction of anesthesia. Rather than puncturing the classical paraspinal target near the transverse process with a specific prone or lateral position of the patient, r-PVB is designed to exploit medial spread of local anesthetic along the intercostal-endothoracic-extrapleural continuum, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and specific body positioning. r-PVB addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.",[396,397,369,370],"Benign Gallbladder Disease","Laparoscopic Cholecystectomy",[397,369,370,375,399],"intercostal space block",{"date":378,"type":40},{"date":380,"type":22},{"date":382,"type":22},{"name":46,"class":47},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":420,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":48},"100640180","superior-hypogastric-plexus-block-during-laparoscopic-colorectal-cancer-surgery-100640180","NCT07579780","Superior HypogastrIc plExus bLock During Laparoscopic Colorectal Cancer Surgery","Superior Hypogastric Plexus Block for Early Recovery After Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial","SHIELDS","Inclusion Criteria:\n\n* Able to provide informed consent.\n* Undergoing elective laparoscopic radical resection for colorectal cancer.\n* American Society of Anesthesiologists Physical Status (ASA) class I-III.\n\nExclusion Criteria:\n\n* Allergy to block medication (s).\n* Coagulation dysfunction.\n* Local or systemic infection.\n* Unable to cooperate with the completion of the study protocol.",{"count":413,"type":22},170,[210],"This trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery.",[417,418,419],"Colorectal Cancer (Diagnosis)","Laparoscopic Surgery","Superior Hypogastric Plexus Block",[271,421,422,423],"laparoscopic surgery","superior hypogastric plexus block","Quality of recovery","2026-05-05",{"date":426,"type":40},"2026-05-12",{"date":428,"type":40},"2025-12-15",{"date":430,"type":22},"2027-02-18",{"name":46,"class":47},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":440,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":322,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":454,"locationsCount":4},"100636612","revised-paravertebral-nerve-blocks-for-enhanced-recovery-after-video-assisted-thoracoscopic-pneumonectomy-100636612","NCT07567950","Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy","Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.","r-PVB-1","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases\n\nExclusion Criteria:\n\n* Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics\n* Surgeon-estimated high likelihood of conversion to open surgery\n* Chronic opioid use\n* Heart failure, liver failure, or renal failure\n* Coagulation disorders\n* History of allergy to local anesthetics\n* Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up",true,{"count":442,"type":22},200,[210],"Revised-Paravertebral Nerve Block (r-PVB) is performed right after induction of general anesthesia and before lateral positioning of surgery. Under ultrasound guidance, an intercostal space between the 6th and 8th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block. Traditional Paravertebral Nerve Block (PVB) is performed right after the lateral positioning of surgery under ultrasound guidance. According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches. Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the 6th and 8th transverse processes, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space. Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement. Stop advancing the needle when the tip passes through the superior costotransverse ligament. Administer 2% lidocaine in pulsatile injections, 1-2 ml per pulse, observing the spread of fluid at the needle tip on ultrasound and depression of the pleura. Repeat pulsatile injections until a total of 5 ml lidocaine is administered, and if necessary, increase with another 5 ml of pulsatile lidocaine. The fluid movement and pleura depression observed on ultrasound confirm proper needle placement. Then, use this needle to inject 30 ml of 0.5% ropivacaine to complete the PVB. The surgical procedure will start right after the intervention blocks.",[446,369,370,447],"Video-assisted Thoracoscopic Surgery (VATS)","Lung Diseases",[449,369,370,375,399],"Video-Assisted Thoracoscopic Surgery",{"date":451,"type":40},"2026-05-08",{"date":376,"type":22},{"date":382,"type":22},{"name":46,"class":47},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":48},"100516305","phase-2-safety-and-efficacy-of-pd-1--mfolfox6-neoadjuvant-therapy-in-local-advanced-smpcc-100516305","NCT06002789","Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC","Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair\u002FMicrosatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)","Inclusion Criteria:\n\n1. Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);\n2. Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and PMS2; or at least one tumor lesion identified MSI-H by polymerase chain reaction or next-generation sequencing technique;\n3. Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI;\n4. Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI;\n5. No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;\n6. No colorectal surgery history;\n7. No chemotherapy or radiotherapy history;\n8. No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment;\n9. No endocrinotherapy history restriction;\n10. informed consent assigned.\n\nExclusion Criteria:\n\n1. Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \\> NYHA grade II;\n2. Severe hypertension not well controlled by drugs;\n3. HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA);\n4. Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen;\n5. Other active clinical severe infection(NCI-CTC AE V5.0);\n6. Outside pelvic distant metastasis evidences;\n7. Dyscrasia, organ dysfunction;\n8. Pelvic or abdominal radiotherapy history;\n9. Epilepsy need treatments(Steroid or anti-epilepsy therapy);\n10. Other malignant tumor history within 5 years;\n11. Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results;\n12. Any active autoimmune disease or autoimmune disease history (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators);\n13. Any anti-infection vaccine injection 4 weeks before inclusion;\n14. Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\\>10mg\u002Fday prednisolone or equivalent hormone);\n15. Known or suspicious allergy to any study related drugs;\n16. Any unstable state might cause damage to the safety and compliance of patients;\n17. Pregnant or breast feeding women who has ability to have children while without contraception;\n18. Refuse to sign informed consent.","80 Years",{"count":464,"type":22},17,[25],"At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line\u002Ffirst-line treatment of dMMR\u002FMSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR\u002FMSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H\u002FMSS (dMMR\u002FpMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.",[468,271],"Multiple Cancer",[470,142,471,472],"Synchronous multiple primary colorectal cancer","Neoadjuvant treatment","MSI-H","2026-04-23",{"date":380,"type":40},{"date":476,"type":40},"2022-05-01",{"date":478,"type":22},"2028-12-01",{"name":46,"class":47},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":462,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":503,"locationsCount":48},"100411860","watch-and-wait-in-pd-1-monoclonal-antibody-treated-dmmrmsi-h-distal-rectal-cancer-100411860","NCT04643041","Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR\u002FMSI-H Distal Rectal Cancer","Watch and Wait in Patients With dMMR\u002FMSI-H Distal Rectal Cancer Accessed Pathological Complete Response After PD-1 Monoclonal Antibody Therapy-an Open Label, Multicenter, Prospective Study (BASKET)","BASKET","Inclusion Criteria:\n\nPreliminary inclusion criteria：\n\n* Histological identified rectal adenocarcinoma,\n* Tumor biopsy immunohistochemical (IHC) identified dMMR, including one or more deficient of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as deficient mismatch repair(dMMR), or next generation sequencing identified (MSI-H)； MRI identified tumor inferior margin lower than peritoneal reflection,\n* Clinical staging TxNxM0, with or without positive MRF, with or without positive EMVI,\n* Staging method：all patients undergo rectal palpation, high resolution MRI ± transrectal Ultrasound examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI,\n* No intestinal obstruction symptom，or obstruction relieved after proximal colostomy,\n* No rectal surgery history,\n* No chemotherapy or radiotherapy history,\n* No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment,\n* Endocrinotherapy history restriction:No\n* Informed consent assigned, Final inclusion criteria：\n* Clinical complete response (cCR)(Chest,abdominal and pelvic enhanced CT or pelvic enhanced MRI or transrectal ultrasound proved)\n* Transrectal ultrasound biopsy or endoscopic biopsy proved pathologically complete response (pCR)\n\nExclusion Criteria:\n\n* Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin)，symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \\> NYHA grade II,\n* Severe hypertension not well controlled by drugs,\n* HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA),\n* Active tuberculosis(TB)，accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen,\n* Other active clinical severe infection(NCI-CTC V5.0),\n* Outside pelvic distant metastasis evidences,\n* Dyscrasia, organ dysfunction,\n* Pelvic or abdominal radiotherapy history,\n* Multiple CRC or Multi-primary tumors；\n* Epilepsy need treatments(Steroid or anti-epilepsy therapy),\n* Other malignant tumor history within 5 years,\n* Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results,\n* Any active autoimmune disease or autoimmune disease history (including but not restricted：interstitial pneumonia, uveitis,enteritis, hepatitis,hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators),\n* Any anti-infection vaccine injection 4 weeks before inclusion ,\n* Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\\>10mg\u002Fday prednisolone or equivalent hormone)；\n* Known or suspicious allergy to any study related drugs,\n* Any unstable state might cause damage to the safety and compliance of patients,\n* Pregnant or breast feeding women who has ability to have children while without contraception,\n* Refuse to sign informed consent",{"count":489,"type":22},47,[210],"Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR\u002FMSI-H) colorectal cancer (CRC) , more than fifty percent of dMMR\u002FMSI-H CRC patients might get pathological complete response(pCR) after PD-1 monoclonal antibody treatment. For distant rectal cancer(RC), radical resection and neoadjuvant chemotherapy or chemoradiotherapy might cause lots of treatment cost,damage to defecation and sexual function, acute toxicity, chronic dysfunction, even loss of anus and psychological disorder. This study aims to evaluate the effect and safety of watch and wait in patients with dMMR\u002FMSI-H distal RC accessed pCR after PD-1 monoclonal antibody therapy.",[493],"Rectal Cancer",[495,496,497,498],"PD-1 monoclonal antibody","watch and wait","dMMR\u002FMSI-H","distal rectal cancer",{"date":380,"type":40},{"date":501,"type":40},"2021-01-01",{"date":353,"type":22},{"name":46,"class":47},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":48},"100609548","phase-4-interleukin-23-monoclonal-antibody-for-inflammatory-bowel-disease-efficacy-and-safety-100609548","NCT07216014","Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety","Analysis of the Efficacy and Safety of Interleukin-23 Monoclonal Antibody in Inflammatory Bowel Disease: A Prospective Study","Inclusion Criteria:\n\n1. Male or female subjects aged between 18 and 65 years at the baseline visit;\n2. Patients diagnosed with CD and UC as per the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023 · Guangzhou) and the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 · Xi'an);\n3. If the subject is a fertile female, a pregnancy test must be conducted at the baseline to rule out pregnancy. The entire trial process must follow the contraceptive recommendations of this project (see below); women without reproductive potential (defined as post-menopause or permanent surgical sterilization) do not need to undergo a pregnancy test at the baseline;\n4. The subjects fully understand the purpose of the trial, and should have a basic understanding of the pharmacological effects of the trial drugs and the possible adverse reactions; in accordance with the spirit of the Helsinki Declaration, they voluntarily sign the informed consent form and comply with the requirements of this research protocol.\n\nExclusion Criteria:\n\n1. Diagnosed with ischemic enteritis, infectious enteritis, radiation enteritis, NSAIDs-related enteritis, and other autoimmune enteropathies;\n2. Unable to administer IL-23 inhibitors regularly by intravenous or subcutaneous injection;\n3. Evidence of toxic megacolon was detected during screening;\n4. Previously underwent small bowel resection, ileocecal resection, extensive colon resection, subtotal resection or total colon resection, rectal resection, ileostomy, colostomy;\n5. Subjects who need surgery due to the condition or plan to undergo elective surgery during the study;\n6. Complicated with severe liver and kidney dysfunction;\n7. Complicated with active bacterial or viral infections, chronic infections;\n8. Biologic agents are contraindicated such as active tuberculosis with positive chest X-ray or strongly positive tuberculin skin test, active tuberculosis within the past five years, myocardial infarction, heart failure or demyelinating neurological diseases;\n9. Had severe opportunistic infections during screening, such as severe or recurrent herpes zoster, active cytomegalovirus infection, Pneumocystis jirovecii, Histoplasma capsulatum, etc. infections;\n10. Have a history of gastrointestinal dysplasia, or any biopsy during endoscopic examination has revealed dysplasia, excluding completely resected low-grade dysplastic lesions; Patients with a known history of lymphoid tissue proliferative diseases (including lymphoma), or with signs and symptoms of lymphoid tissue proliferative diseases (such as lymphadenopathy and\u002For splenomegaly); Patients with current or past malignant tumors.",{"count":442,"type":22},[238],"Patients diagnosed with moderate to severe CD or UC by the end of the study period were selected. After obtaining informed consent, treatment with infliximab-based drugs was initiated. Basic patient information and medical history were collected. The treatment process was followed, and the drug treatment plan was adjusted based on physician experience. Follow-up and disease assessments were conducted at 0, 4, 8, 16, 24, 48, and 54 weeks. At corresponding follow-up time points, blood, stool, and tissue samples were collected for gastrointestinal endoscopy, imaging examinations, laboratory tests, symptom self-assessment by participants, adverse reaction assessment, and nutritional risk screening. The efficacy and safety of IL-23 inhibitor treatment for CD or UC were comprehensively evaluated.\n\nAfter the study began, regular check-ups and evaluations were required when necessary or before medication administration. Venous blood samples were collected, or fecal collection boxes were provided for stool collection. When intestinal endoscopy was required for re-examination, one piece of normal and one piece of diseased intestinal mucosa tissue were collected each time. When surgery was required, two pieces of normal and two pieces of diseased intestinal mucosa tissue were collected each time. Sample collection does not affect the disease treatment and evaluation process. If any discomfort occurs during IL-23 inhibitor treatment, or if there are new changes in the condition or any unexpected situations, including hospitalization at other medical institutions, disability, etc., regardless of whether they are related to the study, participants should notify the investigator promptly to allow for judgment and appropriate medical treatment or advice to ensure safety.",[515],"Crohn's Disease and Ulcerative Colitis",[517],"Interleukin 23","2026-04-22",{"date":520,"type":40},"2026-04-24",{"date":522,"type":40},"2025-12-01",{"date":524,"type":22},"2026-10-10",{"name":46,"class":47},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":48},"100575032","phase-2-sbrt--pd-1-antibody-in-unresectable-locally-recurrent-rectal-cancersparkle-100575032","NCT06767007","SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）","Evaluation of the Efficiency and Safety of Stereotactic Body Radiation Therapy Combined With PD-1 Antibody in the Treatment of Unresectable Locally Recurrent Rectal Cancer: A Prospective, Multicenter, Single-Arm, Open Label, Phase II Study","Inclusion Criteria:\n\n1. Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary signature and dated must be obtained in accordance with regulations and institutional guidelines;\n2. Patients with pMMR\u002FMSS colorectal cancer;\n3. Age between 18 and 75 years;\n4. Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent lesion cannot achieve a one-stage R0 resection (unresectable is defined as: 1. Pelvic MRI showing sacral infiltration at or above S2, 2. And\u002For lateral pelvic wall invasion, 3. And\u002For obturator vascular nerve infiltration, 4. After MDT discussion, there are no indications for a one-stage R0 resection, 5. The patient refuses total pelvic exenteration or debulking surgery);\n5. Locally recurrent rectal adenocarcinoma without clear distant metastasis at diagnosis\u002FMDT team assesses oligometastases as resectable\u002Fcontrollable (UICC 8th edition);\n6. No prior radiotherapy, or a gap of more than 6 months between the completion of initial radiotherapy and the start of retreatment, with a previous radiotherapy dose of less than 50.4Gy, and no late toxicity in the small bowel or bladder;\n7. ECOG performance status 0-1;\n8. Peripheral blood counts and liver and kidney functions within the following allowed ranges (tested within 15 days before treatment start):\n\n   * White blood cells (WBC) ≥ 3.0×10\\^9\u002FL or Absolute Neutrophil Count (ANC) ≥ 1.5×10\\^9\u002FL;\n\n     * Hemoglobin (HGB) ≥ 80 g\u002FL;\n\n       * Platelets (PLT) ≥ 100×10\\^9\u002FL;\n\n         * Liver transaminases (AST\u002FALT) \\\u003C 3.0 times the upper limit of the normal range;\n\n           * Total bilirubin (TBIL) \\\u003C 1.5 times the upper limit of the normal range;\n\n             * Creatinine (CREAT) \\\u003C 1.5 times the upper limit of the normal range;\n9. No history of other malignancies, not pregnant or breastfeeding, and should use effective contraception during the study period and for 6 months after the last administration;\n10. Expected survival ≥ 12 months.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum-based agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks of enrollment;\n3. History of receiving anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell co-stimulation or checkpoint pathway targeted therapies;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers of the stomach or duodenum, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforations that have not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;\n7. Pregnant or breastfeeding women or women who may become pregnant with a positive pregnancy test before the first dose; or female participants who are unwilling to strictly use contraception during the study period and their partners;\n8. Brain metastases with a diameter greater than 3cm or a total volume greater than 30cc;\n9. Clinical or radiological evidence of spinal cord compression, or tumors within 3 millimeters of the spinal cord on MRI;\n10. History or concurrent presence of other active malignant tumors (except for malignant tumors that have been treated curatively and have not recurred for more than 3 years or carcinoma in situ that can be cured with adequate treatment);\n11. Combined with severe electrocardiogram abnormalities or active coronary artery disease within 12 months before participating in the study, severe\u002Funstable angina or newly diagnosed angina or myocardial infarction, New York Heart Association (NYHA) Class II or higher congestive heart failure;\n12. Patients with active infections (infections causing fever above 38°C);\n13. Patients with poorly controlled hypercalcemia, hypertension, diabetes;\n14. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n15. Patients with mental disorders affecting clinical treatment or a history of central nervous system diseases;\n16. Patients with severe complications (intestinal obstruction, renal insufficiency, liver dysfunction, cerebrovascular disorders, etc.);\n17. Any toxicity of grade 2 or above from previous treatments that has not yet resolved (except for anemia, alopecia, and skin pigmentation);\n18. Any medical condition that is unstable or would affect patient safety and compliance with the study;\n19. Patients deemed unsuitable for participation in this clinical trial by the investigator.",{"count":534,"type":22},31,[25],"This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy.\n\nResearchers will combine SBRT with PD-1 for ULRRC to see if this treatment can provide a benefit of survival.\n\nParticipants will:\n\n1. Receive chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery\u002FMaintenance therapy.\n2. Visit the clinic once every 3 months for checkups and tests",[538],"Unresectable Locally Recurrent Rectal Cancer",[538,540,495],"Stereotactic Body Radiation Therapy",{"date":473,"type":40},{"date":543,"type":40},"2025-01-06",{"date":545,"type":22},"2027-11-30",{"name":46,"class":47},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":48},"100523431","efficacy-and-safety-of-vedolizumab-combined-with-upadacitinib-in-patients-with-ulcerative-colitis-100523431","NCT06095596","Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis","Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis\n* Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2\n* Indications for VDZ or UPA application\n\nExclusion Criteria:\n\n* Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy\n* Evidence of toxic megacolon was found during screening\n* Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC\n* Subjects who require surgery due to UC or plan to undergo elective surgery during the study period\n* There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases\n* Evidence of active hepatitis B or C infection during screening",{"count":555,"type":22},334,[210],"It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.",[559],"Ulcerative Colitis (UC)",{"date":561,"type":40},"2026-04-28",{"date":563,"type":40},"2023-11-01",{"date":565,"type":22},"2026-10-31",{"name":46,"class":47},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":322,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":590,"locationsCount":48},"100635134","phase-2-improvement-effect-of-dexamethasone-enema-for-acute-radiation-induced-rectal-injury-100635134","NCT07548736","Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury","Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Aged 18 to 75 years, regardless of gender;\n2. Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;\n3. Patients pathologically diagnosed with rectal cancer;\n4. Undergoing conventional pelvic radiotherapy (total dose of 40-50.4Gy in 25-28 fractions);\n5. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;\n6. Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.\n\nExclusion Criteria:\n\n1. Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;\n2. Patients who have received pelvic radiotherapy;\n3. Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;\n4. Pregnant or breastfeeding women;\n5. Patients expected to undergo major surgery during the study period;\n6. Participation in other clinical trials within 4 weeks prior to enrollment;\n7. A history of alcohol abuse, drug use, or substance abuse within the past year;\n8. Severe allergic constitution, or allergy to dexamethasone;\n9. Inability to cooperate with the enema;\n10. Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.",{"count":575,"type":22},40,[25],"Research Objective and Principle: Through a randomized controlled study, evaluate the effectiveness of dexamethasone in improving radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy, thereby providing evidence for treatment options in patients at risk of radiation-induced rectal injury and aiming for adoption in international guidelines.\n\nPrimary Objective: Improvement rate of radiation-induced rectal injury. Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of pelvic radiotherapy, safety of dexamethasone enema, quality of life, pathological complete response (pCR) rate.\n\nStudy Design: Prospective, single-center, randomized controlled study. Study Population and Expected Enrollment: Patients with rectal cancer undergoing conventional pelvic radiotherapy, expecting to enroll 40 patients.\n\nTrial Duration: From February 2026 to February 2028.\n\nIntervention:\n\nExperimental Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.\n\nControl Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.\n\nStatistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 86%, and it is expected that the experimental group can reduce it to 40%. The sample size was estimated using a formula designed to compare 2 proportions, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.",[579],"Acute Radiation Enteritis",[581,582,583,584],"Acute radiation-induced rectal injury","Rectal cancer","Conventional pelvic radiotherapy","Dexamethasone enema","2026-04-21",{"date":473,"type":40},{"date":520,"type":22},{"date":589,"type":22},"2028-04-24",{"name":46,"class":47},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":598,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":48},"100615776","phase-2-stereotactic-body-radiation-therapy-for-unresectable-locally-recurrent-rectal-cancer-100615776","NCT07297004","Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer","Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study","Inclusion Criteria:\n\n1. Written informed consent;\n2. 18-75 years of age;\n3. Histologically, cytologically, or radiologically confirmed tumor recurrence, and the MDT assesses that the recurrent lesion cannot achieve R0 resection (unresectable defined as: 1) Pelvic MRI shows infiltration of S2 or above, 2) and\u002For lateral pelvic invasion, 3) and\u002For neurovascular invasion of the pelvic, 4) No indication for R0 resection after MDT discussion);\n4. No clear distant metastasis at the time of diagnosis of locally recurrent rectal adenocarcinoma or MDT assesses that oligometastatic lesions are resectable or controlable (UICC 8th edition);\n5. No previous radiotherapy for initial treatment, or more than 6 months between completion of initial radiotherapy and start of re-radiotherapy, with a previous radiotherapy dose of less than 50.4 Gy, and no grade 3-4 radiotherapy side effects in the small intestine or bladder;\n6. ECOG score for performance status is 0-1 (Appendix 1);\n7. Peripheral blood cell counts and liver and kidney function within the following acceptable ranges (tested within 15 days before treatment):\n\n   * White blood cell count more than 3.0×10\\^9\u002FL or neutrophils more than 1.5×10\\^9\u002FL;\n\n     * Hemoglobin more than 80 g\u002FL; ③ Platelets more than 100×10\\^9\u002FL; ④ ALT or AST less than 3 times the upper limit of normal; ⑤ Total bilirubin less than 1.5 times the upper limit of normal; ⑥ Creatinine less than 1.5 times the upper limit of normal;\n8. No history of other malignant tumors, non-pregnant or lactating patients, participants must use effective contraception during the study and for 6 months after the last treatment;\n9. Expected survival more than 12 months.\n\nExclusion Criteria:\n\n1. Patients with a history of severe allergies to drugs, including platinum-based drugs, 5-FU, LV, and 5-HT3 receptor antagonists;\n2. Patients who have participated in or are participating in other clinical trials within 4 weeks of enrollment;\n3. Severe electrolyte abnormalities;\n4. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or unresected tumors that are actively bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment;\n5. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding history or bleeding tendency within 2 months;\n6. Pregnant or lactating women or women with a positive pregnancy test before the first medication; or female participants and their partners unwilling to strictly use contraception during the study;\n7. Brain metastases with a diameter greater than 3 cm or a total volume greater than 30 cc;\n8. Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI;\n9. History of other active malignant tumors (except for those who have received curative treatment and have been disease-free for over 3 years or in situ cancers that can be cured with adequate treatment);\n10. Severe ECG abnormalities, active coronary artery disease, or severe and uncontrolled angina, newly diagnosed angina, or myocardial infarction within 12 months before participating in the study, congestive heart failure of NYHA class II or above;\n11. Patients with active infections (fever above 38°C due to infection);\n12. Patients with poorly controlled hypercalcemia, high blood pressure, or diabetes;\n13. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n14. Patients with mental disorders affecting clinical treatment or a history of central nervous system diseases;\n15. Patients with severe complications (intestinal obstruction, renal failure, liver failure, cerebrovascular disorders, etc.);\n16. Any unresolved toxicity from previous treatments that is grade 2 or higher according to CTCAE (excluding anemia, alopecia, skin pigmentation);\n17. Any medical condition that is unstable or may affect patient safety and study compliance;\n18. Patients deemed unsuitable for participation in this study by the investigator.",{"count":136,"type":22},[25],"Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment.\n\nPrimary Objective: 1-year local progression-free survival (LPFS) . Secondary Objectives: R0 resection rate and overall survival (OS), 2-year LPFS and OS, and side effects of the treatment.\n\nStudy Design: A single-arm, open-label, prospective phase II study. Study Population and Expected Enrollment: Patients with unresectable locally recurrent rectal adenocarcinoma, with an expected enrollment of 40 patients.\n\nScheduled Visits and Duration: December 2024 to November 2027. Trial Duration: December 2024 to November 2027. Intervention: SBRT for unresectable locally recurrent rectal cancer. Statistical Hypothesis: Enrolled patients are those with unresectable recurrent rectal cancer. Based on previous literature reports and retrospective clinical data from our center, it is hypothesized that the 1-year LPFS for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the 1-year LPFS for those receiving SBRT intervention is 40%. Using Simon's optimal two-stage study design, a single-arm study, with α set at 0.05 and 1-β at 0.80, and an expected loss to follow-up rate of 10%.",[538],{"date":520,"type":40},{"date":604,"type":40},"2025-01-01",{"date":606,"type":22},"2026-11-30",{"name":46,"class":47},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":625},"100479458","predicting-the-efficacy-of-neoadjuvant-therapy-in-patients-with-locally-advanced-rectal-cancer-using-an-ai-platform-based-on-multi-parametric-mri-100479458","NCT05523245","Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI","DLARC","Inclusion Criteria:\n\n* Clinical suspicion or colonoscopic pathology of rectal cancer\n* Age over 18 years\n* Informed consent and signed informed consent form\n\nExclusion Criteria:\n\n* Poor magnetic resonance image quality, such as severe artifacts\n* Previous treatment for rectal cancer\n* History or combination of other malignant tumours\n* Not Locally Advanced Rectal Cancer (LARC)\n* Not received neoadjuvant therapy or not completed neoadjuvant therapy\n* No surgery\n* Time interval between MRI and surgery was more than 2 weeks\n* Patients were lost to follow-up and voluntarily withdrew from the study due to adverse reactions or other reasons",{"count":616,"type":22},1700,"Establish a deep learning model based on multi-parameter magnetic resonance imaging to predict the efficacy of neoadjuvant therapy for locally advanced rectal cancer.This study intends to combine DCE with conventional MRI images for DL, establish a multi-parameter MRI model for predicting the efficacy of CRT, and compare it with the DL and non-artificial quantitative MRI diagnostic model constructed by conventional MRI to evaluate the role of DL in MRI predicting CRT. And this study also tries to build a DL platform to assess the efficacy of LARC neoadjuvant radiotherapy and chemotherapy, accurately assess patients' complete respose (pCR) after CRT, and provide an important basis for guiding clinical decision-making.",[493],{"date":473,"type":40},{"date":621,"type":40},"2022-06-24",{"date":623,"type":22},"2027-12",{"name":46,"class":47},4,""]