[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"West China Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":617},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,190,0,25,[9,50,78,100,126,149,175,199,228,254,275,301,312,338,363,385,406,430,449,475,500,520,554,573,592],{"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":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054183","phase-1-hepatic-arterial-infusion-chemotherapy-plus-envafolimab-and-lenvatinib-for-first-line-unresectable-advanced-biliary-tract-cancer-100054183",false,"NCT07636798","Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer","Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib\u002FII, Single-arm Clinical Study","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria:\n\n1. Age between 18 years and \\[missing value\\] years, inclusive.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Histologically or cytologically confirmed biliary tract carcinoma, deemed unsuitable for radical surgical resection.\n4. At least one measurable lesion as determined by the investigator in accordance with mRECIST or RECIST version 1.1.\n5. Estimated life expectancy greater than 3 months.\n6. No prior systemic therapy or local anti-tumor treatment, except for surgery (biliary drainage is permitted).\n7. Patients who experience relapse more than 6 months after completion of postoperative adjuvant therapy may be enrolled.\n8. Child-Pugh score of \\[missing value\\] points.\n9. Adequate organ function to meet the criteria for chemotherapy:\n\n   1. Bone marrow function: absolute neutrophil count ≥ \\[missing value\\]\u002FL; platelet count ≥ \\[missing value\\]; hemoglobin ≥ \\[missing value\\];\n   2. Hepatic function: total bilirubin ≤ \\[missing value\\] × upper limit of normal (ULN); for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ \\[missing value\\] × ULN; for patients with confirmed liver metastases, AST and ALT ≤ \\[missing value\\] × ULN;\n   3. Renal function: serum creatinine ≤ \\[missing value\\] × ULN; routine urinalysis showing urinary protein \\\u003C \\[missing value\\]; if baseline urinary protein is \\[missing value\\], a 24-hour urine collection must confirm total protein ≤ 1 g\u002F24 h;\n   4. Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients receiving anticoagulant therapy, PT must be within the therapeutic range intended for the anticoagulant used.\n10. Female patients must be postmenopausal or, if premenopausal, have a negative urine or serum pregnancy test; male patients must agree to use effective contraception or have undergone surgical sterilization during the trial and for 8 weeks following the final dose of the study drug.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded:\n\n1. Known hypersensitivity to the investigational drug(s).\n2. Current participation in another interventional clinical trial, or receipt of any investigational drug or use of investigational device within 4 weeks prior to first dosing.\n3. History of malignancy outside the biliary tract within 5 years prior to first dosing, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been completely resected.\n4. Previous treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).\n5. History of solid organ or hematopoietic stem cell transplantation.\n6. Any condition requiring systemic corticosteroids (equivalent to prednisone or above) or other immunosuppressive therapy within 14 days prior to randomization.\n7. Active autoimmune disease or history of autoimmune disease with potential for recurrence.\n8. Radiographic evidence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or prior noninfectious pneumonitis identified on screening chest computed tomography (CT).\n9. Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia.\n10. Severe chronic or active infection (including tuberculosis) requiring systemic (oral or intravenous) antibiotic therapy within 14 days prior to randomization.\n11. Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV-1\u002F2 antibody positive); untreated active Hepatitis B. \\*Note: Subjects with Hepatitis B meeting the following criteria are eligible: HBV viral load \\\u003C 2000 copies\u002FmL (200 IU\u002FmL) prior to the first dose, with anti-HBV therapy administered throughout the chemotherapy period to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\\* Patients with active Hepatitis C infection (HCV antibody positive and HCV-RNA above the lower limit of detection) are excluded.\n12. Concurrent participation in another therapeutic clinical trial.\n13. Presence of obstructive jaundice (enrollment permitted following active intervention such as biliary drainage or stenting and subsequent normalization of liver function).\n14. Meeting any of the following cardiovascular criteria:\n\n    1. New York Heart Association (NYHA) Class II or higher heart failure within 3 months prior to initiation of study treatment;\n    2. Major cardiovascular events including myocarditis, myocardial infarction, cerebrovascular events, unstable arrhythmia, or unstable angina within 6 months prior to initiation of study treatment;\n    3. Symptomatic pulmonary embolism within \\[missing value\\] months prior to randomization;\n    4. Known artery disease or left ventricular ejection fraction (LVEF) \\\u003C 40%.\n15. Lactating women.\n16. Women of childbearing potential unwilling to use contraception.\n17. Vulnerable populations other than elderly or illiterate individuals, including those with mental illness, cognitive impairment, or critical illness.\n18. Any other reason deemed by the investigator to render the subject unsuitable for study participation.","ALL","18 Years","75 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib\u002FII trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. It conducts dose exploration to confirm the optimal dosage and evaluates clinical outcomes, aiming to establish a better comprehensive treatment strategy.",[29],"Biliary Tract Cancer",[31,32,33,34,35,36],"Biliary tract cancer","Phase I\u002FII","Immunotherapy,","Lenvatinib","Envafolimab Injection","Hepatic arterial infusion,","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":22},"2026-06",{"date":45,"type":22},"2029-12",{"name":47,"class":48},"West China Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100644001","risk-stratification-and-treatment-decisions-in-infantile-hemangioma-with-minimal-or-arrested-growth-100644001","NCT07669545","Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth","Infantile Hemangioma With Minimal or Arrested Growth Versus Typical Infantile Hemangioma: A Prospective Cohort Study of Risk Stratification and Treatment Decision-Making","IH-MAGRST","Inclusion Criteria:\n\n* Infants clinically diagnosed with infantile hemangioma, including minimal or arrested growth infantile hemangioma and classic infantile hemangioma.\n* Participants undergoing their initial specialist evaluation at the study center.\n* Age at baseline: from birth to 24 months.\n* Sufficient clinical information available for baseline assessment, including lesion location, morphology, size, number of lesions, complications, and treatment recommendation.\n* Parents or legal guardians are able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with vascular anomalies other than infantile hemangioma, including vascular malformations, congenital hemangioma, kaposiform hemangioendothelioma, pyogenic granuloma, or other vascular tumors.\n* Patients with insufficient clinical information to determine the infantile hemangioma subtype, AAP risk category, Hemangioma Severity Scale score, or baseline treatment recommendation.\n* Patients who have received systemic pharmacologic treatment, procedural treatment, laser therapy, or surgical treatment for infantile hemangioma before the baseline specialist evaluation.\n* Patients with severe comorbidities or unstable medical conditions that may interfere with clinical assessment or follow-up.\n* Parents or legal guardians who decline participation or are unable to provide informed consent.","0 Months","12 Months",{"count":61,"type":22},150,"OBSERVATIONAL","Infantile hemangioma with minimal or arrested growth (IH-MAG) is a subtype of infantile hemangioma that shows little or no obvious growth during infancy. Although these lesions may appear less active than classic infantile hemangiomas, some may still be associated with ulceration, functional risk, permanent disfigurement, or structural anomalies.\n\nThis prospective observational cohort study will compare infants with IH-MAG and infants with classic infantile hemangioma at their first specialist evaluation. Each participant will undergo routine clinical assessment, standardized photography, risk classification according to the 2019 American Academy of Pediatrics guideline, and Hemangioma Severity Scale scoring. The main outcome is the initial management recommendation after specialist assessment, categorized as active management or treatment versus observation. The study will not assign any treatment. All management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.",[65],"Infantile Hemangioma (IH)",[67,68],"Infantile Hemangioma With Minimal or Arrested Growth","infantile hemangioma","NOT_YET_RECRUITING","2026-07-01",{"date":72,"type":41},"2026-07-02",{"date":74,"type":22},"2026-06-20",{"date":76,"type":22},"2028-03-30",{"name":47,"class":48},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100632178","phase-1-clinical-study-of-msh2---tumor-cell-vaccines-for-advanced-pmmr-colorectal-cancer-patients-100632178","NCT07510308","Clinical Study of MSH2-\u002F- Tumor Cell Vaccines for Advanced pMMR Colorectal Cancer Patients","A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of MSH2-\u002F- Tumor Cell Vaccines in Patients With Advanced pMMR Colorectal Cancer.","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years at the time of acquisition informed consent form.\n2. Patients with histologically or cytologically confirmed pMMR colorectal cancer based on molecular typing, who have experienced failure of, are intolerant to, or refuse standard therapy.\n\n   1. For patients with RAS\u002FBRAF wild-type disease who are eligible for targeted therapy, enrollment is permitted only after they have previously received standard regimens containing an anti-EGFR monoclonal antibody or an anti-VEGF monoclonal antibody and subsequently experienced disease progression.\n   2. For patients with a BRAF V600E mutation, enrollment is permitted only after failure of prior treatment with a regimen containing a BRAF inhibitor in combination with chemotherapy.\n   3. For patients who do not meet the above molecular criteria, enrollment is permitted only after failure of at least two prior lines of systemic chemotherapy, including platinum-based agents.\n3. The presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2.\n5. Predicted survival time ≥3 months.\n6. The main organs are functioning well and the following requirements are met within 7 days before receiving treatment:\n\n   ① Hemoglobin (HGB) ≥80 g\u002FL (no blood transfusion within 14 days); Absolute neutrophil count (ANC) \\>1.5×109\u002FL; White blood cell count ≥3.0×109\u002FL; Platelet count (PLT) ≥80×109\u002FL;\n\n   ② Total bilirubin ≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; If there was liver metastasis, ALT or AST≤5×ULN;\n\n   ③ Creatinine (SCr) ≤1.5×ULN or creatinine clearance (CRCI) estimated by Cockcroft-Gault formula ≥60 mL\u002Fmin;\n\n   ④ Prothrombin time (PT), international normalized ratio (INR) ≤1.5×ULN (unless anticoagulation with warfarin);\n\n   ⑤ Cardiac function: left ventricular ejection fraction ≥50%. QTcF interval ≤450 ms.\n7. Men of childbearing potential and women of childbearing age voluntarily use effective contraceptive methods (e.g., condoms, intrauterine devices, spermicides) from the time of signing the informed form until 6 months after the completion of vaccination, and contraceptive use is not allowed. Female cancer patients who have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after receipt of the trial vaccine;\n8. The washout period of previous anti-tumor therapy should be at least 4 weeks, and the washout period of molecular targeted drugs should be at least 5 half-lives. Palliative radiotherapy needs to have been completed for at least 2 weeks; Chest radiation therapy needed to have been completed for at least 3 months, and major surgery needed to have been completed with at least 4 weeks of recovery.\n\nExclusion Criteria:\n\n1. The patient has a history of other tumors in the past, except for the history of malignant tumors that have been cured and have not recurred within 5 years before screening, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, and intramucosal cancer of the gastrointestinal tract, which the investigator considers to be eligible for enrollment.\n2. Have any uncontrolled clinical diseases (e.g., diseases of the respiratory system, circulatory system, digestive system, nervous system, hematologic system, urogenital system, endocrine system) or psychiatric or other major medical condition that the investigator considers to interfere with the provision of informed consent, to interfere with the interpretation of the trial results, to pose a risk to the study participants, or to otherwise interfere with the achievement of the study objectives.\n3. Have any active autoimmune disease or a history of autoimmune disease. Participants with asthma for which medical intervention with bronchodilators was required could not be included.\n4. Allergy to the trial drug (including any excipients). Previous history of severe allergy to any drug, food or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.\n5. There are contraindications to subcutaneous injection.\n6. Received prior antitumor therapeutic vaccine or cellular immunotherapy.\n7. Participated in other drug or device clinical trials 4 weeks before screening.\n8. Study participants on systemic therapy with corticosteroids (\\>10 mg\u002F day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of vaccine. Inhaled or topical steroids and adrenal hormone replacement at a therapeutic dose of prednisone of 10 mg or less per day were allowed in the absence of active autoimmune disease.\n9. Before the first dose of the study drug. Any toxic effects from previous antineoplastic therapy have not recovered to NCI CTCAE grade 5.0 ≤1 (any degree of alopecia, other than grade 2 previous platinum-based treatment-related neuropathy).\n10. Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n11. Have a history of substance abuse or known medical, psychological, or social conditions such as alcohol or drug abuse.\n12. Have received any vaccine within 30 days before receiving the study vaccine or plan to receive any vaccine other than the study vaccine during the study.\n13. The presence of any other factor that was deemed by the investigator to preclude study participant entry into the trial or that study participant had any medical condition that could interfere with the assessment of the safety or efficacy of the study treatment.\n14. Study participants who were unwilling or unable to comply with study requirements.",{"count":86,"type":22},9,[25],"The goal of this clinical trial is to evaluate the safety and tolerability of an MSH2-\u002F- tumor cell vaccine and to explore its preliminary antitumor activity and immunogenicity in adults with advanced proficient mismatch repair (pMMR) colorectal cancer who have failed, are intolerant of, or decline standard systemic therapies at West China Hospital, Sichuan University. The main objectives are to determine the incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs) related to the vaccine (n\u002FN, %, graded per NCI CTCAE v5.0), to assess preliminary antitumor activity (objective response per RECIST v1.1, progression-free survival, and overall survival), and to characterize the vaccine's immunogenicity profile.\n\nThis study using a 3+3 dose-escalation design with three dose levels of the MSH2-\u002F- tumor cell vaccine (1×10\\^7, 2.5×10\\^7, and 5×10\\^7 cells per dose), manufactured under GMP conditions and administered by intradermal injection. Each participant will receive four induction vaccinations (three doses every 2 weeks and a fourth dose 1 month after the third), followed by up to eight booster doses every 4 weeks based on tumor response. Participants will undergo protocol-specified safety monitoring with clinical assessments, laboratory tests, and documentation of all AEs\u002FSAEs, and tumor response will be evaluated regularly by imaging per RECIST v1.1. After treatment completion or discontinuation, participants will enter safety and long-term follow-up for disease status and survival.",[90],"pMMR\u002FMSS Advanced Colorectal Cancer","2026-06-26",{"date":93,"type":41},"2026-06-30",{"date":95,"type":41},"2026-06-11",{"date":97,"type":22},"2027-10-01",{"name":47,"class":48},2,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":49},"100617244","clinical-trial-of-an-anti-fog-drainage-device-for-endoscopic-endonasal-sellar-region-tumor-surgery-100617244","NCT07316101","Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery","Inclusion Criteria:\n\n* Age 18-75 years\n* Pre-operative MRI\u002FCT diagnosis of pituitary adenoma or craniopharyngioma ≤ \\*3 cm without extensive skull-base invasion\n* Scheduled for elective endoscopic endonasal transsphenoidal resection\n* ASA physical status I-III\n* Able and willing to give written informed consent and comply with follow-up\n\nExclusion Criteria:\n\n* Severe nasal anatomical deformity, polyps, or prior nasal surgery preventing device placement\n* Active nasal or systemic infection (WBC \\> 10 × 10⁹\u002FL, CRP ≥ 10 mg\u002FL)\n* Known intracranial infection or ongoing CSF leak\n* Coagulopathy (PT \\> 14 s or APTT \\> 45 s) or anticoagulation that cannot be stopped ≥ 7 days\n* Allergy to silicone or medical-grade plastics\n* Planned combined transcranial or transorbital approach\n* Pregnancy or breastfeeding\n* Psychiatric or cognitive disorder precluding informed consent or follow-up",{"count":21,"type":22},[108],"NA","The goal of this clinical trial is to learn if the anti-fog suction device works to keep the surgical view clear during endoscopic nose-to-pituitary operations and whether it lowers the chance of brain-fluid infection. It will also learn about the safety of the device.\n\nThe main questions it aims to answer are:\n\n* Does the device reduce the total time the surgeon has to stop because the lens fogs up?\n* What medical problems (such as nose-bleed, tube blockage, or infection) do participants have when the device is used?\n\nResearchers will compare the anti-fog device to the usual \"water-squirt\" method to see if the device works better.\n\nParticipants will:\n\n* Have either the device or the usual water method applied during their planned pituitary surgery\n* Stay in the hospital for the normal recovery period (about 3-5 days) and return for a routine check-up around day 7\n* Allow the study team to record operating times, any fog-related pauses, and results of blood or spinal-fluid tests taken before and after surgery",[111,112],"Pituitary Adenoma","Craniopharyngioma",[114,115,116,117,118,119],"endoscopic endonasal surgery","pituitary adenoma","anti-fog device","suction irrigation","intracranial infection","randomized controlled trial",{"date":93,"type":41},{"date":122,"type":41},"2026-03-01",{"date":124,"type":22},"2026-12-31",{"name":47,"class":48},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":133,"minAge":18,"maxAge":19,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100644880","phase-1-a-single-arm-open-label-prospective-study-evaluating-the-safety-tolerability-and-immunogenicity-of-the-neooviv-vaccine-in-patients-with-ovarian-cancer-after-surgery-100644880","NCT07676890","A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVIV Vaccine in Patients With Ovarian Cancer After Surgery","NeoOVIV","Inclusion Criteria:\n\n1. Female, aged between 18 and 75 years (inclusive) at the time of signing the written informed consent form (ICF)\n2. Patients with histopathologically confirmed epithelial ovarian cancer (EOC), including: a) Patients with Stage II (Stage IIA\u002FIIB, tumor confined to the pelvis with no extra-abdominal metastasis) or Stage III (Stage IIIA\u002FIIIB\u002FIIIC, tumor involving the serosal surface of intra-abdominal viscera or regional lymph node metastasis) disease, in accordance with the International Federation of Gynecology and Obstetrics (FIGO) 2014 Staging System; b) Have undergone cytoreductive surgery (CRS), with postoperative pathological confirmation of R1 resection (R1 defined as microscopic residual tumor at the surgical margin ≤ 1 mm); c) Qualified tumor tissue obtained during surgery is available for neoantigen screening: ① Fresh tumor tissue ≥ 100 mg (collected on the day of surgery and immediately immersed in RNA stabilization reagent); or ② ≥ 5 unstained sections of formalin-fixed paraffin-embedded (FFPE) tissue (each with a thickness of 5 μm, tumor cellularity ≥ 30%, and no significant necrosis); d) Whole-exome sequencing (WES) combined with RNA sequencing confirms the presence of ≥ 5 \"usable neoantigens\" (defined as: HLA binding affinity IC50 \\\u003C 500 nM, and transcript expression level of the mutant gene in transcripts per million (TPM) ≥ 1);\n3. In accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, postoperative contrast-enhanced pelvic MRI\u002FCT shows no macroscopic residual disease (R2 resection), and lung metastasis, liver metastasis, and bone metastasis are excluded;\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1 (0: Fully ambulatory, no restriction in daily activities; 1: Ambulatory and able to perform light physical activity, no significant fatigue or dyspnea), with an expected overall survival of ≥ 1 year;\n5. Adequate function of major organs, with relevant laboratory test results within 14 days prior to enrollment meeting the following requirements (no blood transfusion or blood product administration, no use of hematopoietic growth factors, albumin, or other blood products during this period): Hematology tests: Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 100 × 10⁹\u002FL; Serum biochemistry tests: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine (SCr) ≤ 1.5 × ULN, or creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault formula; Endocrine tests: Thyroid-stimulating hormone (TSH), free triiodothyronine (free T3), and free thyroxine (free T4) are within the normal reference range; Coagulation function tests: Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.2 × ULN;\n6. Women of childbearing potential (WOCBP) must have a negative serum β-human chorionic gonadotropin (β-HCG) test prior to enrollment, and agree to use effective contraceptive measures (e.g., condoms, intrauterine device \\[IUD\\]) during the study period (from the first dose administration to 6 months after the last dose administration);\n7. Good treatment compliance, and the patient and their family members agree to cooperate with and complete the scheduled survival follow-up.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed non-epithelial ovarian cancer, including ovarian germ cell tumors (e.g., teratoma, yolk sac tumor), sex cord-stromal tumors (e.g., granulosa cell tumor), and metastatic ovarian tumors (e.g., Krukenberg tumor metastatic to the ovary from the gastrointestinal tract);\n2. R2 resection (macroscopic residual disease) after cytoreductive surgery, or postoperative imaging (contrast-enhanced pelvic MRI\u002FCT, chest CT) showing distant metastasis (e.g., lung, liver, brain metastasis), or FIGO stage IV disease;\n3. Prior treatment with any therapeutic cancer vaccine (e.g., peptide vaccine, DNA vaccine, other mRNA vaccines); or prior use of immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies) with the last dose administered ≤ 30 days before enrollment;\n4. Severe surgery-related complications within 4 weeks postoperatively, including but not limited to: intra-abdominal infection requiring intravenous antibiotics for ≥ 7 days, enteric fistula requiring surgical repair, massive hemorrhage requiring transfusion ≥ 400 mL within 24 hours, severe adhesive intestinal obstruction requiring gastrointestinal decompression for ≥ 3 days;\n5. Active autoimmune disease, or a history of autoimmune disease currently requiring long-term (≥ 2 weeks) immunosuppressive therapy, including but not limited to: rheumatoid arthritis requiring prednisone ≥ 10 mg\u002Fday or equivalent immunosuppressants, systemic lupus erythematosus requiring hydroxychloroquine plus glucocorticoids, ulcerative colitis with acute flare within the past 1 year, multiple sclerosis with relapse within the past 2 years, autoimmune thyroiditis requiring high-dose levothyroxine \\> 150 μg\u002Fday;\n6. Active infection within 1 month before enrollment, including but not limited to: Bacterial infections: pneumonia requiring intravenous antibiotics, pyelonephritis with positive urine culture and fever; Viral infections: HBsAg-positive with HBV DNA ≥ 1×10³ IU\u002FmL (untreated); HCV RNA-positive (untreated with direct-acting antivirals or persistently positive after treatment); HIV-positive; acute varicella-zoster virus (VZV) or cytomegalovirus (CMV) infection with fever or organ involvement; Fungal infections: pulmonary candidiasis, aspergillosis (confirmed by imaging and positive fungal culture);\n7. Severe organ dysfunction or history thereof: acute myocardial infarction, unstable angina, heart failure (NYHA class ≥ II), severe arrhythmia (e.g., ventricular tachycardia requiring medication) within the past 6 months; uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite antihypertensive treatment); acute exacerbation of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis (CT-proven with FEV1\u002FFVC \\\u003C 70% on pulmonary function testing), active pulmonary tuberculosis (positive sputum smear or strongly positive tuberculin test without completed standard anti-tuberculosis therapy); liver cirrhosis (Child-Pugh class B or higher), active hepatitis (ALT\u002FAST \\> 5×ULN), gastrointestinal bleeding within the past 1 year (e.g., esophagogastric variceal bleeding); chronic renal failure requiring dialysis or creatinine clearance \\\u003C 50 mL\u002Fmin (calculated by Cockcroft-Gault formula), nephrotic syndrome (24-hour urinary protein \\> 3.5 g);\n8. Uncontrolled diabetes mellitus (fasting blood glucose ≥ 11.1 mmol\u002FL despite hypoglycemic agents); hyperthyroidism or hypothyroidism with free T3 and free T4 remaining outside the normal range despite medical treatment;\n9. Hypersensitivity to any component of the investigational products, including but not limited to: mRNA vaccine components (liposomes, poly-ICLC adjuvant), anti-PD-1 antibodies (e.g., pembrolizumab, nivolumab); or prior severe allergic reactions to similar biological agents (e.g., COVID-19 mRNA vaccines, other monoclonal antibodies) such as anaphylactic shock, laryngeal edema, bronchospasm;\n10. Use of immunosuppressive agents within 2 weeks before enrollment, including but not limited to: glucocorticoids (prednisone ≥ 10 mg\u002Fday or equivalent), cyclosporine, tacrolimus, methotrexate, azathioprine; or planned use of such agents during the trial;\n11. Diagnosis of another malignancy other than ovarian cancer within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and ductal carcinoma in situ of the breast, all of which must have undergone radical surgery with no recurrence;\n12. Pregnant (positive serum β-HCG before enrollment) or lactating female; woman of childbearing potential refusing effective contraception during the trial (from first dose to 6 months after last dose);\n13. Psychiatric disorders (e.g., dementia, major depressive disorder, schizophrenia) or cognitive impairment that prevents understanding of trial procedures or compliance with follow-up;\n14. Participation in another interventional clinical trial (receipt of investigational drugs, devices, or other study interventions) within 30 days before enrollment; or currently in the follow-up period of another clinical trial without completing the final assessment;\n15. Unable to provide written informed consent or unwilling to comply with trial-related requirements for personal reasons;\n16. Any other condition deemed inappropriate by the investigator.","FEMALE",{"count":86,"type":22},[25],"This is a Phase I, single-arm, open-label, dose-escalation study in patients with stage II or III ovarian cancer after surgery. The study will evaluate the safety, tolerability, immune response, and preliminary clinical activity of NeoOVIV, a personalized mRNA-lipid nanoparticle vaccine, when given with standard adjuvant chemotherapy and a PD-1 antibody.",[138,139],"Ovarian Cancer","mRNA Vaccine",[138,141],"mRNA vaccine","2026-06-23",{"date":93,"type":41},{"date":145,"type":22},"2026-07-31",{"date":147,"type":22},"2028-05-30",{"name":47,"class":48},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":174,"locationsCount":49},"100644176","phase-4-abrupt-discontinuation-versus-gradual-tapering-of-propranolol-in-infantile-hemangioma-100644176","NCT07665177","Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma","Rebound Growth After Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma: A Multicenter Randomized Noninferiority Trial","PROIHSTOP","Inclusion Criteria:\n\n1. Children with a clinical diagnosis of infantile hemangioma.\n2. Complete pretreatment clinical documentation is available, including clinical photographs and\u002For ultrasound findings.\n3. The child has received oral propranolol for at least 6 months.\n4. The infantile hemangioma meets the predefined criteria for propranolol discontinuation, defined as complete or near-complete clinical regression, no obvious residual blood flow on ultrasound, and stable maximal regression for 3 months.\n5. Written informed consent is provided by a parent or legal guardian.\n6. The parent or legal guardian is able and willing to complete the scheduled follow-up assessments.\n\nExclusion Criteria:\n\n1. Airway or hepatic infantile hemangiomas, or other high-risk lesions for which rebound growth could rapidly compromise life or vital organ function.\n2. Use of propranolol for arrhythmia, hypertension, or another cardiovascular indication.\n3. A history of rebound growth after prior discontinuation of propranolol.\n4. Laser therapy, sclerotherapy, surgery, systemic corticosteroids, or other systemic treatment within 3 months before randomization.\n5. Severe cardiac, respiratory, hepatic, renal, metabolic, or other systemic disease that may affect participant safety or study assessment.\n6. Inability to complete standardized photography, ultrasound assessment, or scheduled follow-up.","6 Months","60 Months",{"count":160,"type":22},110,[162],"PHASE4","Infantile hemangioma is the most common benign vascular tumor in infancy. Oral propranolol is the first-line systemic treatment for infantile hemangiomas requiring therapy. Although most patients respond well to propranolol, rebound growth may occur after treatment discontinuation, and some patients may require restarting propranolol or receiving additional treatment. In clinical practice, propranolol may be discontinued abruptly after the lesion meets discontinuation criteria, or gradually tapered over several weeks before complete discontinuation. However, high-quality randomized evidence comparing these two discontinuation strategies remains limited.\n\nThis multicenter randomized noninferiority trial aims to compare the risk of rebound growth after abrupt discontinuation versus gradual tapering of propranolol in patients with infantile hemangioma who have received oral propranolol for at least 6 months and meet predefined discontinuation criteria.",[65],[166,167,168],"Infantile hemangioma","Propranolol","rebound growth","2026-06-18",{"date":171,"type":41},"2026-06-24",{"date":70,"type":22},{"date":76,"type":22},{"name":47,"class":48},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":182,"maxAge":18,"enrollmentInfo":183,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":49},"100641866","parental-distress-and-treatment-adherence-in-pediatric-recurrent-medulloblastoma-100641866","NCT07660458","Parental Distress and Treatment Adherence in Pediatric Recurrent Medulloblastoma","Parental Distress as a Predictor of Treatment Adherence in Pediatric Recurrent Medulloblastoma: A Prospective Longitudinal Cohort Study","Inclusion Criteria(Children):\n\n* Diagnosis of medulloblastoma with documented recurrence (radiographic or histopathological confirmation)\n* Age ≤ 18 years at enrollment\n* Currently receiving active treatment for recurrent disease\n* Life expectancy ≥ 3 months\n\nInclusion Criteria (Parents\u002FCaregivers):\n\n* Primary caregiver responsible for medication administration and treatment coordination\n* Age ≥ 18 years\n* Able to read and understand study materials in \\[English\\]\n* Willing to complete study assessments\n\nExclusion Criteria:\n\n* Child receiving exclusively palliative\u002Fhospice care\n* Parent with severe psychiatric illness or cognitive impairment preventing informed consent or questionnaire completion\n* Child enrolled in another interventional trial that would confound adherence measurement","0 Years",{"count":184,"type":22},450,"Children with medulloblastoma, an aggressive brain tumor, require prolonged and complex multimodal therapy. Their primary parental caregivers bear the main responsibility for ensuring treatment adherence, yet the psychological toll on these caregivers may undermine their ability to follow prescribed regimens. This study investigates whether multidimensional parental distress predicts overall treatment adherence in this population, and which specific distress domains are most strongly associated with poor adherence.\n\nParental distress-including depression, anxiety, and posttraumatic stress-is common among parents of children with cancer and may interfere with their ability to manage complex treatment regimens. However, no study has specifically examined whether parental distress predicts treatment adherence in children with recurrent medulloblastoma, a devastating brain tumor with a poor prognosis and no standard treatment protocol.\n\nThis prospective longitudinal cohort study aims to investigate whether parental distress is a significant predictor of treatment adherence in children with recurrent medulloblastoma. A total of 450 parent-child dyads will be enrolled across 4 tertiary pediatric oncology centers. Children must have a confirmed diagnosis of recurrent medulloblastoma and be receiving active treatment. Parents (primary caregivers) will complete validated questionnaires at baseline assessing depression, anxiety, stress, and trauma-related distress using the DASS-21 and IES-R. Treatment adherence will be monitored over a 12-month follow-up period using electronic medication monitoring caps, clinic attendance records, and parent-reported medication logs.\n\nThe primary outcome is the proportion of prescribed chemotherapy doses taken (treatment adherence rate). Secondary outcomes include trajectories of adherence over time and the relationship between specific dimensions of parental distress (depression, anxiety, stress, posttraumatic stress) and adherence patterns. The study will also examine whether child clinical factors (e.g., molecular subgroup, prior treatment history) and family demographic factors moderate this relationship.\n\nFindings from this study may inform the development of targeted psychosocial interventions to support distressed parents and improve treatment adherence-and ultimately clinical outcomes-in this vulnerable pediatric population. Participants can expect to be enrolled in the study for approximately 12 months.",[187,188],"Medulloblastoma","Recurrent Medulloblastoma",[190],"Pediatric Brain Tumor；Parental Distress；Treatment Adherence；Psycho-Oncology；Caregiver Stress","2026-06-16",{"date":193,"type":41},"2026-06-22",{"date":195,"type":41},"2025-06-01",{"date":197,"type":22},"2026-07-30",{"name":47,"class":48},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":207,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":49},"100642088","phase-2-psma-petct-guided-sbrt-plus-darolutamide-in-mhspc-100642088","NCT07649421","PSMA PET\u002FCT-Guided SBRT Plus Darolutamide in mHSPC","A Multicenter, Prospective, Randomized Controlled Phase II Trial of PSMA PET\u002FCT-Guided Stereotactic Body Radiotherapy Combined With Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer","PSMA-DaroRT","Inclusion Criteria:\n\n* Male participants aged ≥18 years and \\\u003C85 years.\n* Histologically confirmed prostate adenocarcinoma.\n* No neuroendocrine carcinoma, ductal adenocarcinoma, small-cell carcinoma, signet-ring cell carcinoma, or sarcomatoid carcinoma component.\n* Metastatic prostate cancer confirmed by imaging or pathological evidence.\n* PSMA PET\u002FCT and FDG PET\u002FCT show ≤20 metastatic lesions.\n* PSMA PET\u002FCT and FDG PET\u002FCT show concordant tracer uptake activity.\n* No prior systemic or local anti-tumor treatment for prostate cancer.\n* No prior androgen deprivation therapy.\n* No prior first-generation antiandrogen therapy.\n* No prior androgen receptor signaling inhibitor therapy, including abiraterone, enzalutamide, apalutamide, rezvilutamide, or darolutamide.\n* No prior chemotherapy for prostate cancer.\n* No prior radical prostatectomy.\n* No prior radiotherapy for prostate cancer.\n* Expected survival \\>12 months.\n* Able to understand the study and voluntarily sign written informed consent.\n* Able and willing to comply with study visits and protocol procedures.\n* Willing to provide tumor tissue, blood, and other biological samples as required by the study protocol.\n* Absolute neutrophil count ≥1.5 × 10\\^9\u002FL.\n* Platelet count ≥100 × 10\\^9\u002FL.\n* Hemoglobin ≥90 g\u002FL.\n* Total bilirubin ≤1.5 × upper limit of normal.\n* Alanine aminotransferase and aspartate aminotransferase ≤2.5 × upper limit of normal.\n* Serum albumin ≥20 g\u002FL.\n* Serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥50 mL\u002Fmin.\n* Eastern Cooperative Oncology Group performance status ≤2.\n\nExclusion Criteria:\n\n* Current or prior history of another primary malignancy.\n* History of another malignancy within 3 years that differs from the study cancer in primary site or histology.\n* History of papillary thyroid carcinoma is allowed if it is well controlled.\n* History of basal cell carcinoma of the skin is allowed if it is well controlled.\n* History of squamous cell carcinoma of the skin is allowed if it is well controlled.\n* History of cervical carcinoma in situ is allowed if it is well controlled.\n* Prior radical prostatectomy.\n* Prior external beam radiotherapy.\n* Prior radical or ablative local therapy for prostate cancer.\n* Prior treatment with an androgen receptor signaling inhibitor, including abiraterone, enzalutamide, apalutamide, rezvilutamide, or darolutamide.\n* Prior chemotherapy for prostate cancer.\n* Major surgery within 4 weeks before enrollment.\n* Serious trauma within 4 weeks before enrollment.\n* Contraindication to radiotherapy.\n* Spinal cord compression.\n* Active enteritis.\n* Severe pelvic infection.\n* Inability to maintain the required body position for radiotherapy.\n* History of allergy to PET\u002FCT tracer.\n* Nuclear medicine assessment showing super bone imaging.\n* Marked discordance between PSMA PET\u002FCT and FDG PET\u002FCT findings.\n* Disease progression during the 6-month run-in period of androgen deprivation therapy plus darolutamide before randomization.\n* Unacceptable toxicity during the 6-month run-in period of androgen deprivation therapy plus darolutamide before randomization.\n* No active tumor lesion on PSMA PET\u002FCT after the 6-month run-in period.\n* Allergy to any component of the study treatment.\n* Active or poorly controlled serious infection.\n* Human immunodeficiency virus infection.\n* Acute or chronic active hepatitis B infection, defined as positive hepatitis B surface antigen with hepatitis B virus DNA \\>1 × 10\\^3\u002FmL.\n* Acute or chronic active hepatitis C infection, defined as positive hepatitis C virus antibody with hepatitis C virus RNA \\>15 IU\u002FmL.\n* Active pulmonary tuberculosis.\n* Other serious infectious disease.\n* New York Heart Association class III or IV congestive heart failure.\n* Persistent symptomatic arrhythmia.\n* Uncontrolled atrial fibrillation.\n* Left ventricular ejection fraction below the lower limit of normal on repeated echocardiographic assessments.\n* Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.\n* Arterial thrombotic, embolic, or ischemic event within 6 months before enrollment.\n* Myocardial infarction within 6 months before enrollment.\n* Unstable angina within 6 months before enrollment.\n* Cerebrovascular accident within 6 months before enrollment.\n* Transient ischemic attack within 6 months before enrollment.\n* Medical condition requiring warfarin or coumarin anticoagulation therapy.\n* Uncontrolled hypercalcemia, defined as ionized calcium \\>1.5 mmol\u002FL, total calcium \\>12 mg\u002FdL, or corrected serum calcium above the upper limit of normal.\n* Symptomatic hypercalcemia requiring continuous bisphosphonate therapy.\n* Uncontrolled adrenal insufficiency.\n* History of abdominal fistula within 6 months before enrollment.\n* History of gastrointestinal perforation within 6 months before enrollment.\n* History of intra-abdominal abscess within 6 months before enrollment.\n* Severe non-healing wound.\n* Severe non-healing ulcer.\n* Gastrointestinal disease that may impair absorption.\n* Active peptic ulcer disease.\n* Uncontrolled nausea.\n* Uncontrolled vomiting.\n* Uncontrolled diarrhea.\n* History of small bowel resection that may impair drug absorption.\n* Other acute or chronic disease, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study treatment.\n* Other acute or chronic disease, psychiatric disorder, or laboratory abnormality that may interfere with interpretation of study results.\n* Any other medical or psychological condition that, in the investigator's judgment, may affect participant safety, compliance, or study integrity.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.","MALE","85 Years",{"count":210,"type":22},254,[26],"This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy. Participants whose cancer has not progressed and who still have active tumor lesions on prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT) will then be randomly assigned to one of two groups. One group will continue darolutamide plus androgen deprivation therapy. The other group will receive stereotactic body radiotherapy (SBRT) to all active tumor lesions identified by PSMA PET\u002FCT, while continuing darolutamide plus androgen deprivation therapy. The main purpose of this study is to find out whether adding PSMA PET\u002FCT-guided SBRT can help participants live longer without tumor growth seen on scans or death. The study will also evaluate prostate-specific antigen (PSA) changes, time to castration-resistant prostate cancer, overall survival, side effects, and quality of life.",[214],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[216,217,218,219,220],"PSMA PET\u002FCT","SBRT","Darolutamide","Androgen Deprivation Therapy","Metastasis-Directed Therapy","2026-06-14",{"date":191,"type":41},{"date":224,"type":22},"2026-08-01",{"date":226,"type":22},"2031-10-01",{"name":47,"class":48},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":133,"minAge":18,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100643334","a-comparative-study-of-delayed-endoscopic-dti-and-autologous-flap-reconstruction-post-mastectomy-100643334","NCT07602868","A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy","A National Multicenter, Prospective, Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Autologous Flap Breast Reconstruction Following Mastectomy","DEDIA","Inclusion Criteria:\n\n* Female patients aged 18-70 years\n* One year after Modified Radical Mastectomy (MRM), Nipple-Sparing Mastectomy (NSM), or Skin-Sparing Mastectomy (SSM), or six months after the completion of radiotherapy, provided the local skin remains viable and sufficiently lax;\n* voluntary participation and ability to provide written informed consent.\n\nExclusion Criteria:\n\n* History of breast surgery in which the pectoralis major muscle was removed;\n* Patients with serious preoperative co-morbidities and poor general condition who cannot tolerate the surgery;\n* Diabetes mellitus with a long history of smoking or combined poor glycemic control;\n* current enrollment in other clinical trials that may interfere with study outcomes;\n* Review (clinical, imaging, pathological basis) reveals the presence of local\u002Fregional recurrence or uncontrollable distant metastasis.","70 Years",{"count":238,"type":22},588,"In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term psychosocial distress. Current delayed reconstruction options are limited: traditional two-stage implant reconstruction necessitates two surgeries with associated costs and risks like infection and implant exposure, while autologous tissue transfer (e.g., TRAM\u002FDIEP flaps), though offering superior natural aesthetics and patient satisfaction, involves extensive donor-site morbidity, prolonged recovery, and significant scarring, restricting its suitability. To address the drawbacks of both established methods-significant trauma, cost, and complexity-this study evaluates a novel technique for breast cancer patients post-mastectomy: endoscopic delayed direct-to-implant breast reconstruction. This study proposes to conduct a prospective cohort study to analyze complication rates, breast aesthetic scores, quality of life metrics, and other dimensions between delayed direct-to-implant breast reconstruction and abdominal flap breast reconstruction（DIEP and TRAM). The aim is to comprehensively evaluate the safety and clinical feasibility of endoscopic delayed direct-to-implant breast reconstruction.",[241],"Breast Reconstruction After Mastectomy",[243,244,245],"delayed Endoscopic DTI","DIEP","TRAM","2026-06-08",{"date":248,"type":41},"2026-06-10",{"date":250,"type":22},"2026-09-01",{"date":252,"type":22},"2030-12-31",{"name":47,"class":48},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":99},"100636556","phase-1-clinical-study-of-novel-therapeutic-vaccine-for-advanced-solid-tumors-100636556","NCT07567222","Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors","Safety, Tolerability, and Preliminary Antitumor Activity of Novel Therapeutic Tumor Vaccines in Advanced Solid Tumors","Inclusion Criteria\n\n1. Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history:\n\n   Part A1: Patients with advanced osteosarcoma who achieved Stable Disease (SD) or Partial Response (PR) following first-line chemotherapy, and have at least one remaining lung metastatic lesion \\>= 0.5 cm.\n\n   Part A2: Patients with advanced osteosarcoma who have relapsed, metastasized, or progressed following prior chemotherapy, or who are intolerant to the toxicities of previous systemic therapy.\n\n   Part B1: Patients with advanced pancreatic cancer and disease progression following \\>= 1 prior line of standard systemic therapy.\n\n   Part C1: Patients with advanced HNSCC and disease progression following \\>= 2 prior lines of systemic therapy.\n\n   Part D1: Patients with advanced colon cancer and disease progression following \\>= 3 prior lines of therapy (including fluoropyrimidine, oxaliplatin, and irinotecan). Patients with RAS wild-type must have received EGFR inhibitors.\n\n   Part E1: Patients with advanced hepatocellular carcinoma (HCC) and disease progression following \\>= 2 prior lines of systemic therapy.\n\n   Part F1: Patients with advanced glioma and disease progression following the first-line Stupp regimen.\n\n   Part G1: Patients with advanced pancreatic cancer and disease progression following \\>= 1 prior line of therapy.\n\n   Part H1: Patients with advanced or recurrent metastatic breast cancer who have progressed on or after \\>= 3 prior lines of systemic therapy.\n2. Age 18-75 years.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n4. Life expectancy \\> 3 months.\n5. Adequate organ function within 7 days prior to first dose, including:\n\n   Hematologic: Hemoglobin (Hb) \\>= 80 g\u002FL; White Blood Cell count (WBC) \\>= 3.0 x 10\\^9\u002FL; Platelet count (PLT) \\>= 80 x 10\\^9\u002FL; Absolute Neutrophil Count (ANC) \\>= 1.5 x 10\\^9\u002FL.\n\n   Hepatic: Total bilirubin \\\u003C= 1.5 x ULN (\\\u003C= 3 x ULN for liver metastases or HCC); ALT and AST \\\u003C= 2.5 x ULN (\\\u003C= 5 x ULN for liver metastases or HCC).\n\n   Renal: Creatinine clearance \\> 60 mL\u002Fmin (Cockcroft-Gault formula). Coagulation: International Normalized Ratio (INR) \\\u003C= 1.5 x ULN.\n6. At least one measurable or evaluable lesion per RECIST v1.1.\n7. Ability to understand and sign written informed consent and comply with study procedures.\n\nExclusion Criteria\n\n1. Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.\n2. Active central nervous system (CNS) metastases or leptomeningeal disease.\n3. Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA \\>= 500 IU\u002FmL or \\>= 2000 copies\u002FmL).\n4. Active pulmonary tuberculosis.\n5. Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) within 4 weeks prior to first dose.\n6. Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high risk of bleeding or perforation.\n7. Arterial\u002Fvenous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade \\>= 3 bleeding event within 28 days prior to treatment.\n8. Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.\n9. Known hypersensitivity or intolerance to study treatment components or related compounds.\n10. Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study.\n11. Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.",{"count":262,"type":22},54,[25],"Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.\n\nBuilding on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.\n\nThis is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC.\n\nThe primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.",[266],"Malignant Tumor","2026-06-07",{"date":269,"type":41},"2026-06-09",{"date":271,"type":41},"2026-06-05",{"date":273,"type":22},"2027-06-30",{"name":47,"class":48},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":283,"maxAge":19,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":49},"100642777","phase-4-capra-evo-a-randomized-serial-pcct-trial-of-early-evolocumab-after-acs-100642777","NCT07612774","CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS","A Single-center, Randomized Controlled Comparison of Effect of Evolocumab Versus Standard Lipid Lowering Therapy on Plaque Progression in Patients With Acute Coronary Syndrome by Serial PCCT(CAPRA-EVO Trial)","CAPRA-EVO","Inclusion Criteria:\n\nEligible patients must meet the following criteria:\n\n* Age between 40 and 75 years.\n* Diagnosis of ACS, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) or unstable angina (UA).\n* Successful PCI treatment, with post-procedural TIMI grade 3 flow and residual stenosis \\\u003C30% and atherosclerotic plaque presence in non-culprit coronary vessels (not attributed to this target event).\n* Suboptimal LDL-C control: Patients must have received any statin treatment for at least 4 weeks, with an LDL-C level ≥1.8 mmol\u002FL; or Statin-naive patients must have an LDL-C level ≥3.2 mmol\u002FL.\n* Agreement to complete baseline CCTA and laboratory tests within 7 days of enrollment and signed informed consent.\n* Commitment to complete 52 weeks of follow-up.\n\nExclusion Criteria:\n\n* History of coronary artery bypass grafting (CABG).\n* History of valve surgery.\n* History of PCI treatment before the index ACS event\n* Complex bifurcation lesions (Medina 1,1,1).\n* Use of PCSK9 inhibitors (e.g., evolocumab, alirocumab) or potent CYP3A4 inhibitors (e.g., itraconazole) within the last 12 months.\n* Known intolerance to statins, evolocumab, or other investigational drugs related to the study.\n* Hepatic or renal insufficiency (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² or ALT\u002FAST \\>3 times the upper limit of normal).\n* Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).\n* Uncontrolled heart failure (NYHA class III-IV) or malignant arrhythmias.\n* Known allergy or hypersensitivity to iodinated contrast media\n* Hyperthyroidism or active thyroid disease\n* Pregnancy or breastfeeding (or plans for pregnancy within the next year).\n* Life expectancy of less than 1 year (e.g., due to advanced malignancy).\n* Participation in another interventional clinical trial within the past 3 months.","40 Years",{"count":285,"type":22},233,[162],"The CAPRA-EVO trial is a single-center, randomized, open-label study with blinded endpoint assessment comparing early evolocumab plus standard lipid-lowering therapy versus standard-of-care lipid-lowering therapy in patients with acute coronary syndrome after successful percutaneous coronary intervention. The study will use serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to assess changes in non-culprit coronary plaque burden and stenosis severity. Secondary outcomes include changes in high-risk plaque features, lipid and inflammatory biomarkers, cardiovascular events, and safety outcomes. The trial aims to determine whether early intensive LDL-C lowering with evolocumab can reduce coronary plaque progression and support PCCT-CCTA as a noninvasive tool for monitoring atherosclerotic plaque dynamics.",[289,290],"Coronary","Coronary Artery Disease",[292,293,294,119],"acute coronary syndrome","coronary computed tomography angiography","proprotein convertase subtilisin\u002Fkexin type 9",{"date":269,"type":41},{"date":297,"type":22},"2026-05-19",{"date":299,"type":22},"2029-01-31",{"name":47,"class":48},{"id":302,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":27,"conditions":305,"keywords":306,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":311,"locationsCount":49},"100643447",{"count":21,"type":22},[25,26],[29],[31,32,33,34,35,36],"2026-06-03",{"date":269,"type":41},{"date":43,"type":22},{"date":45,"type":22},{"name":47,"class":48},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":337,"locationsCount":99},"100643512","phase-1-akkermansia-muciniphila-akk-for-radiation-induced-skin-injury-100643512","NCT07635277","Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury","Clinical Application of AKK Bacterial Preparation for the Treatment of Radiation-Induced Skin Injury","AKK-RIS","Inclusion Criteria:\n\n* Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy\n* Age ≥18 years and ≤75 years, any sex\n* Signed written informed consent\n* Radiation field skin area can be localized and skin inflammation can be assessed\n* ECOG performance status 0-1, life expectancy ≥3 months\n* Adequate major organ function\n* Fertile patients (both sexes) must use effective medical contraception during the study and for 6 months after the last dose\n* Willing to comply with follow-up and skin image collection\n\nExclusion Criteria:\n\n* Cognitive impairment preventing understanding of the study\n* Use of antibiotics or antifungals within 1 month\n* Previous treatment with other bacterial preparations\n* Participation in other bacterial therapy trials\n* Any abnormality (e.g., scar, tattoo) in the radiation field that would interfere with assessment\n* Allergy to probiotics or any component of the study preparation; history of severe allergic reactions (e.g., anaphylaxis, angioedema, respiratory distress, allergic purpura, Arthus reaction)\n* Use of immunosuppressive drugs\n* Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves\n* Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)\n* Pregnancy or breastfeeding\n* Active tuberculosis, bacterial or fungal infection (grade ≥2 per CTCAE), or HIV infection\n* Substance abuse or psychiatric disorder\n* Active autoimmune disease or history thereof (exceptions: vitiligo, childhood asthma fully resolved with no intervention in adulthood)\n* History of alcohol or drug abuse\n* Planned pregnancy from screening until 12 months after last treatment\n* Any concomitant condition that, in the investigator's judgment, would compromise patient safety or study completion\n* Any other condition deemed unsuitable for enrollment by the investigator\n* Inability to provide written informed consent",{"count":321,"type":22},40,[25],"This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.",[325],"Radiation-Induced Skin Injury",[327,325,328,329,330,331,332],"Acute Radiation Dermatitis","Akkermansia muciniphila","AKK","Topical Probiotic","Breast Cancer","Head and Neck Cancer",{"date":269,"type":41},{"date":335,"type":41},"2026-03-07",{"date":124,"type":22},{"name":47,"class":48},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":353,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":49},"100638659","phase-1-intratumoral-injection-of-recombinant-human-endostatin-adenovirus-eds01-for-the-treatment-of-recurrent-or-metastatic-head-and-neck-tumors-100638659","NCT07625423","Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors","A Phase I Clinical Trial of Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) Combined With Toripalimab for the Treatment of Recurrent or Metastatic Head and Neck Tumors","EDS01 HN","Inclusion Criteria:\n\nAdults aged 18 to 65 years. Histologically or cytologically confirmed recurrent or metastatic head and neck tumor.\n\nPreviously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent\u002Fmetastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment.\n\nNot suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection.\n\nAt least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1.\n\nNo chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment.\n\nEstimated life expectancy of at least 12 weeks. ECOG performance status 0 to 1. Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment.\n\nRecovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ANC ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, total bilirubin ≤1.5 × ULN, ALT and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN.\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\nKnown allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.\n\nReceiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes at a dose greater than prednisone 10 mg\u002Fday (or equivalent) within 2 weeks before enrollment.\n\nActive autoimmune disease or history of autoimmune disease. Congenital or acquired immunodeficiency. Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration. Severe coagulation disorder or bleeding tendency. Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment.\n\nAcute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","65 Years",{"count":86,"type":22},[25],"This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment.\n\nA total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.",[351,352],"Head & Neck Cancer","Nasopharyngeal Cancinoma (NPC)",[354,355,356],"head and neck cancer","nasopharyngeal cancer","recombinant human endostatin adenovirus",{"date":358,"type":41},"2026-06-04",{"date":360,"type":41},"2026-03-27",{"date":76,"type":22},{"name":47,"class":48},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":182,"maxAge":370,"enrollmentInfo":371,"targetDuration":157,"studyType":62,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":384,"locationsCount":49},"100638638","screening-lumbar-syndrome-in-infants-with-infantile-hemangiomas-100638638","NCT07616323","Screening LUMBAR Syndrome in Infants With Infantile Hemangiomas","Diameter Threshold for Screening LUMBAR Syndrome in Infants With Lumbosacral, Sacrococcygeal, Perineal, and Gluteal Infantile Hemangiomas: A Prospective Multicenter Cohort Study","Inclusion Criteria:\n\n1. Clinically diagnosed infantile hemangioma.\n2. Lesion located in at least one of the following regions: lumbosacral region, sacrococcygeal region, gluteal region, perineal region, perianal region, external genital region, or continuous extension to the lower limb.\n3. Maximal lesion diameter ≥2.0 cm.\n4. Written informed consent obtained from the parents or legal guardians.\n\nExclusion Criteria:\n\n1. Vascular anomaly other than infantile hemangioma, such as venous malformation, lymphatic malformation, arteriovenous malformation, or congenital hemangioma.\n2. Previously diagnosed genetic or congenital syndrome unrelated to LUMBAR syndrome, which may independently explain the detected anomalies.\n3. Incomplete clinical data preventing accurate measurement of lesion diameter.\n4. Refusal of participation or refusal to complete core screening examinations.\n5. Any condition judged by the investigators to be unsuitable for study participation.","10 Years",{"count":372,"type":22},70,"The objective of this study is to determine the maximal diameter threshold at which infants with lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb extending infantile hemangiomas should undergo screening for LUMBAR syndrome.",[375],"LUMBAR Syndrome",[377,378,68],"LUMBAR syndrome","screening","2026-05-29",{"date":381,"type":41},"2026-06-01",{"date":381,"type":22},{"date":273,"type":22},{"name":47,"class":48},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":405,"locationsCount":4},"100638046","phase-2-hope-07-mibc-disitamab-vedotin-plus-immunotherapy-vs-chemoimmunotherapy-in-resectable-her2-expressing-mibc-100638046","NCT07608224","HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC","A Prospective, Randomized Controlled Study of Perioperative Disitamab Vedotin Plus Immunotherapy Versus Chemotherapy Plus Immunotherapy in Patients With Resectable HER2-Expressing Muscle-Invasive Bladder Cancer (HOPE-07-MIBC Study)","HOPE-07-MIBC","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent and comply with study requirements and scheduled assessments.\n2. Male or female patients aged ≥18 years at the time of signing informed consent.\n3. Histologically or radiologically confirmed muscle-invasive bladder cancer (MIBC) staged as cT2-T4aN0\u002F1M0 according to AJCC 8th edition, with residual disease after transurethral resection of bladder tumor (TURBT) as assessed by the investigator. All patients must have histological evidence of muscularis propria invasion. For mixed histology tumors, urothelial carcinoma must be the predominant component (≥50%).\n4. HER2 expression ≥1+ confirmed by immunohistochemistry (IHC) testing of pretreatment tumor tissue in a local laboratory.\n5. Deemed suitable for radical cystectomy as assessed by the investigator.\n6. No prior systemic chemotherapy or immunotherapy for muscle-invasive bladder cancer.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n8. Adequate organ function as defined by the following laboratory criteria obtained within 14 days prior to enrollment (unless otherwise specified):\n\n   Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥100 × 10⁹\u002FL Hemoglobin ≥90 g\u002FL International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN) Total bilirubin ≤1.5 × ULN AST, ALT, and alkaline phosphatase ≤2.5 × ULN Creatinine clearance (CrCl) \\>40 mL\u002Fmin Left ventricular ejection fraction (LVEF) ≥50% For borderline renal function: CrCl ≥40 to \\\u003C60 mL\u002Fmin (defined subgroup); adequate renal function: CrCl ≥60 mL\u002Fmin\n9. Women of childbearing potential must agree to use highly effective contraception during the study and for at least 180 days after the last dose of disitamab vedotin or toripalimab (whichever occurs later). A negative urine or serum pregnancy test is required within 7 days prior to enrollment.\n10. Non-sterilized male patients must agree to use highly effective contraception during the study and for at least 180 days after the last dose of disitamab vedotin or toripalimab (whichever occurs later).\n11. Life expectancy of more than 12 months.\n12. Willing and able to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, HER2, or any other immune checkpoint or T-cell co-stimulatory pathways.\n2. Receipt of any systemic anticancer therapy or systemic immunomodulatory agents (e.g., interferon, interleukin-2, tumor necrosis factor) within 28 days prior to enrollment.\n3. Prior radiotherapy for bladder cancer.\n4. Prior systemic antitumor therapy for bladder cancer (e.g., chemotherapy), except for intravesical chemotherapy or immunotherapy completed at least 2 weeks prior to initiation of study treatment.\n5. Major surgery or significant traumatic injury within 28 days prior to enrollment. Placement of vascular access devices and transurethral resection of bladder tumor (TURBT) are not considered major surgery.\n6. Severe infections requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrollment (hepatitis B virus infection is addressed in exclusion criterion 12).\n7. Receipt of live vaccines within 28 days prior to enrollment (inactivated influenza vaccines are allowed; intranasal vaccines are considered live vaccines and are not allowed).\n8. Use of traditional Chinese medicine or proprietary Chinese medicine with anti-cancer intent within 14 days prior to enrollment.\n9. Active autoimmune disease requiring systemic treatment that may interfere with study therapy as judged by the investigator.\n10. Requirement for long-term systemic corticosteroids or other immunosuppressive therapy that may interfere with study treatment.\n11. Any uncontrolled comorbid conditions that may affect study participation, including but not limited to significant electrolyte abnormalities, hypoalbuminemia, interstitial lung disease, non-infectious pneumonitis, uncontrolled tuberculosis, neurological disorders, psychiatric disorders, or uncontrolled systemic diseases. This includes uncontrolled cardiovascular disease such as active cardiac disease within 6 months prior to enrollment, including severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, or clinically significant arrhythmias requiring treatment.\n12. Chronic hepatitis B infection with HBV DNA ≥500 IU\u002FmL (2500 copies\u002FmL) without adequate antiviral therapy. Patients with inactive HBsAg carrier status or well-controlled HBV infection (HBV DNA \\\u003C500 IU\u002FmL under antiviral therapy) may be eligible. HBV DNA testing is required only in HBsAg-positive patients.\n13. Active hepatitis C infection. Patients who are HCV antibody negative, or HCV antibody positive with negative HCV RNA, are eligible. HCV RNA testing is required for HCV antibody-positive patients.\n14. History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency disorders, or prior allogeneic stem cell transplantation or solid organ transplantation.\n15. Known hypersensitivity to any study drug, its excipients, or other monoclonal antibodies.\n16. Pregnant or breastfeeding women.\n17. Concurrent participation in another interventional clinical trial.\n18. Presence of another active malignancy, except for adequately treated non-melanoma skin cancer or other malignancies considered cured.\n19. Any condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study",{"count":394,"type":22},240,[26,396],"PHASE3","This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab combined with chemotherapy in patients with resectable HER2-expressing (HER2 1+, 2+, or 3+) muscle-invasive bladder cancer (MIBC, cT2-4aN0\u002F1M0).A total of 240 patients will be enrolled and randomized in a 1:1 ratio to receive either RC48 plus toripalimab or chemotherapy plus toripalimab, with 120 patients in each arm.\n\nThe primary objective is to compare 2-year event-free survival (2-year EFS) between the two treatment groups.\n\nSecondary endpoints include pathological complete response (pCR), event-free survival (EFS), disease-free survival (DFS), 1-year event-free survival (1-year EFS), metastasis-free survival (MFS), overall survival (OS), R0 resection rate, and safety outcomes including adverse events (AEs), serious adverse events (SAEs), vital signs, physical examination, ECOG performance status, laboratory tests, and electrocardiography, assessed according to CTCAE v5.0.\n\nExploratory objectives include assessment of quality of life using EQ-5D-5L and EORTC QLQ-C30, evaluation of associations between biomarkers (HER2 expression, PD-L1 expression, circulating tumor DNA) and treatment efficacy, and multi-omics analyses using tumor tissue, ctDNA, and urinary tumor DNA to identify potential predictive biomarkers.",[399],"Urinary Bladder Neoplasms","2026-05-24",{"date":402,"type":41},"2026-05-27",{"date":74,"type":22},{"date":252,"type":22},{"name":47,"class":48},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":49},"100634345","phase-1-controlled-cold-exposure-combined-with-pd-1pd-l1-immunotherapy-in-solid-tumors-nivalis-100634345","NCT07538479","Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Solid Tumors (NIVALIS)","NIVALIS Trial: A Single-Center, Prospective, Single-Arm, Open-Label Phase I Exploratory Study Evaluating the Safety, Feasibility, and Preliminary Antitumor Activity of Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Patients With Solid Tumors","NIVALIS","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard PD-1\u002FPD-L1 inhibitor monotherapy or a standard combination regimen containing PD-1\u002FPD-L1 inhibitors.\n\n  4\\. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.\n\n  5\\. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative pathological assessment are available, even if RECIST measurability is not fully met.\n\n  6\\. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.\n\n  7\\. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.\n\n  9\\. Cardiopulmonary function at rest adequate to tolerate the study procedures, without obvious abnormalities indicating intolerance to cold exposure.\n\n  10\\. Toxicities from prior antitumor therapy must have recovered to ≤ Grade 1, except for alopecia or clinically insignificant abnormalities judged by the investigator; for patients previously treated with PD-1\u002FPD-L1 inhibitors, at least 4 weeks must have elapsed before enrollment, and prior related adverse events must have recovered or stabilized sufficiently for re-exposure.\n\n  11\\. No clear contraindication to cold exposure, and deemed able to tolerate cold exposure combined with immunotherapy by the investigator.\n\n  12\\. Negative pregnancy test for women of childbearing potential; participants of reproductive potential must agree to use effective contraception during the study and for at least 3 months after the last dose.\n\n  13\\. Able to understand the study objectives, procedures, and potential risks, and willing to provide written informed consent.\n\n  14\\. For participants planned for neoadjuvant, perioperative, or conversion therapy, the investigator must confirm that study procedures will not delay planned surgery or other critical treatments.\n\nExclusion Criteria:\n\n* 1\\. Participation in another interventional clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.\n\n  2\\. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.\n\n  3\\. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.\n\n  4\\. Known severe hypersensitivity to the intended PD-1\u002FPD-L1 inhibitor or its excipients.\n\n  5\\. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.\n\n  6\\. Prior severe or life-threatening immune-related adverse events during PD-1\u002FPD-L1 inhibitor therapy that have not resolved or are considered high-risk for re-exposure.\n\n  7\\. Significant cardiovascular disease, including but not limited to unstable angina, severe arrhythmia, NYHA class III-IV heart failure, LVEF \\\u003C50%, or myocardial infarction, stroke, or severe thrombotic events within 6 months.\n\n  8\\. Severe chronic respiratory disease, especially conditions likely to worsen under cold stimulation, such as severe COPD or severe asthma.\n\n  9\\. Clear contraindications to cold exposure, including prior severe cold-related injury, cold urticaria, cryoglobulinemia, active Raynaud's syndrome, or other diseases judged by the investigator to preclude tolerance to a cold environment.\n\n  10\\. Uncontrolled symptomatic central nervous system metastases. 11. Severe psychiatric illness, cognitive impairment, substance abuse, or alcohol dependence that would interfere with compliance.\n\n  12\\. Pregnancy or breastfeeding. 13. Uncontrolled diabetes, severe malnutrition, marked frailty, or any other condition judged to make the participant unable to tolerate cold exposure or study procedures.\n\n  14\\. Any situation in which study participation may significantly delay standard therapy, planned surgery, or other critical treatment timing.",{"count":415,"type":22},24,[25],"This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1\u002FPD-L1 inhibitor monotherapy or PD-1\u002FPD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1\u002FPD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1\u002FPD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune\u002Fmetabolic biomarkers when paired tumor tissue is available.",[419,420,421,422],"Solid Tumors","Solid Malignancies","Cold Exposure","Immunotherapy",{"date":424,"type":41},"2026-05-28",{"date":426,"type":41},"2026-04-20",{"date":428,"type":22},"2029-06-30",{"name":47,"class":48},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":236,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":49},"100637337","phase-1-ymn-a02-for-advanced-pmmr-colorectal-cancer-with-liver-metastases-100637337","NCT07610707","YMN-A02 for Advanced pMMR Colorectal Cancer With Liver Metastases","A Phase I Clinical Trial of YMN-A02 in Patients With Advanced pMMR Colorectal Cancer and Liver Metastases: Safety, Tolerability, and Preliminary Efficacy","Inclusion Criteria:\n\n1. Signed the informed consent form approved by the ethics committee.\n2. 18-70 years old; ECOG performance status 0-1.\n3. Histologically or cytologically confirmed colorectal cancer with liver metastases, molecularly classified as pMMR (presence of other distant metastases allowed).\n4. Patients who have failed or are intolerant to standard therapy, or who refuse standard therapy.\n\n   1. For patients with RAS\u002FBRAF wild-type and eligible for targeted therapy: enrollment allowed only after disease progression on a prior standard regimen containing anti-EGFR or anti-VEGF monoclonal antibody.\n   2. For patients with BRAF V600E mutation: enrollment allowed only after failure of a prior BRAF inhibitor-containing chemotherapy regimen.\n   3. For patients who do not meet the above molecular characteristics: enrollment allowed only after failure of at least two prior lines of systemic chemotherapy (including a platinum-containing regimen).\n5. At least one measurable liver metastasis (CT scan long diameter ≥10 mm, slice thickness ≤5 mm).\n6. Life Expectancy≥3 months.\n7. Adequate Major Organ Function (all within 14 days before randomization):\n\n   1. Hemoglobin ≥80 g\u002FL (no transfusion within 14 days); absolute neutrophil count \\>1.5×10⁹\u002FL; platelet count ≥80×10⁹\u002FL.\n   2. Total bilirubin ≤1.5×ULN; ALT\u002FAST ≤2.5×ULN (or ≤5×ULN in the presence of liver metastases); creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n   3. Left ventricular ejection fraction (LVEF) ≥50%.\n8. Good compliance, and family agrees to cooperate with survival follow-up.\n\nExclusion Criteria:\n\n1. Participation in another interventional drug trial within 4 weeks before enrollment.\n2. Prior or concurrent other malignancy, except: carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, superficial bladder tumor, or any other malignancy that has been curatively treated and recurrence-free for ≥5 years.\n3. Poorly controlled heart disease or clinical symptoms, including but not limited to: NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n4. Pregnant or breastfeeding women.\n5. Active infection, including but not limited to: active tuberculosis, systemic bacterial or fungal infection (NCI-CTCAE v5.0 grade ≥2), HIV infection, active HBV (HBV DNA \\>ULN), or active HCV (HCV RNA \\>ULN).\n6. History of substance abuse that cannot be abstained from, or history of psychiatric disorders.\n7. Active or history of autoimmune disease (including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, etc.). Exceptions: vitiligo controlled with only topical agents; childhood asthma completely resolved without any intervention in adulthood. Patients with asthma requiring bronchodilators for medical intervention are excluded.\n8. Prior vaccination with any mRNA-based drug or mRNA formulation.\n9. Prior participation in any clinical trial involving lipid nanoparticle (LNP) formulations.\n10. Contraindications to intravenous infusion.\n11. History of drug abuse, or any medical, psychological, or social condition (e.g., alcoholism or drug addiction) that, in the investigator's judgment, may affect study compliance.\n12. Known allergy, hypersensitivity, or intolerance to any component (active substance or excipients) of the study drug; history of severe allergy to drugs, food, or vaccines, including but not limited to anaphylactic shock, angioedema of the larynx, anaphylactic dyspnea, allergic purpura, thrombocytopenic purpura, or Arthus reaction.\n13. Plan to conceive (either female subject or partner of male subject) from screening through 12 months after the last dose.\n14. Any concurrent condition that, in the investigator's judgment, may compromise patient safety or interfere with study completion.",{"count":438,"type":22},10,[25],"This study was a prospective, single-center, open-label, single-arm, multi-dose ascending phase Ⅰ clinical trial. The investigators constructed a TM10-LNP mRNA preparation encoding CTLA-4 antibody and TGF-β trap bifunction protein (YMN-A02 bifunction RNA preparation). The aim of this study is to provide a new strategy for overcoming the immune tolerance of liver tumors and improving the response rate of immunotherapy. The investigators planned to enroll patients with advanced pMMR liver metastasis from colorectal cancer who failed standard treatment. A modified \"3+3\" design was used, and 10 patients were expected to be enrolled. There were four dose groups of 100μg, 250μg, 500μg and 1000μg. The trial used a modified \"3+3\" dose climbing design, in which one subject was set as a sentinel patient in the initial 100μg dose group. If the subject did not experience DLT during the DLT observation period, the dose was judged safe and escalation to the next group occurred. If DLT occurred, 3 additional subjects in this group would be required for further evaluation. In the subsequent 250μg, 500μg, and 1000μg dose groups, three subjects were enrolled first in each group: if there was no DLT, the number of subjects was increased. If ≥2 of the 3 cases had DLT, the escalation was terminated. If DLT occurred in 1 out of 3 subjects, 3 additional observations would be made in the same dose group. If the incidence of DLT in the total 6 subjects did not exceed 1\u002F6 after the supplement, the escalation could be escalated. Otherwise, the escalation was terminated and the dose was considered as intolerable.",[442],"Colorectal Cancer With Liver Metastatic","2026-05-20",{"date":424,"type":41},{"date":197,"type":22},{"date":447,"type":22},"2028-06-30",{"name":47,"class":48},{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":459,"conditions":460,"keywords":463,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":49},"100639866","phase-1-nalirifoxadebrelimabpulsar-for-advanced-pancreatic-cancer-100639866","NCT07595172","NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer","A Phase I\u002FII Clinical Trial of NALIRIFOX Combined With Adebrelimab and PULSAR as First-Line Treatment for Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Age: 18-75 years, regardless of gender.\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Previously untreated, locally advanced unresectable or metastatic PDAC, with at least one measurable lesion (RECIST v1.1) not previously irradiated.\n* ECOG Performance Status (PS): 0-1.\n* Expected survival ≥ 3 months.\n* Willing and able to comply with study procedures, treatment, and follow-up.\n* No contraindications to radiotherapy.\n* Adequate organ function: WBC ≥ 2.5×10⁹\u002FL, ANC ≥ 1.5×10⁹\u002FL; Platelets ≥ 75×10⁹\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL (no transfusion or EPO dependence within 7 days); Total bilirubin (Tbil) ≤ 1.5×ULN; ALT\u002FAST ≤ 5×ULN;Albumin ≥ 30 g\u002FL; INR ≤ 1.5×ULN; Serum creatinine (Cr) ≤ 1.5×ULN Urine protein ≤ 1+\n* HBsAg-positive patients must have HBV-DNA ≤ 1×10³ IU\u002FmL (copies\u002FmL). If HBV-DNA ≥ 1×10³ IU\u002FmL, patients may still be eligible if chronic HBV is stable and not expected to increase risk, per investigator assessment.\n* Voluntary participation with signed informed consent form.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity to chimeric, human(ized) antibodies, or fusion proteins.\n* Pregnant or breastfeeding women, or men\u002Fwomen of childbearing potential unwilling\u002Funable to use effective contraception during the study.\n* Other malignancies within 5 years, except: Malignancies treated with curative intent and no known active disease for ≥5 years with low recurrence risk; Adequately treated non-melanoma skin cancer or lentigo maligna without disease evidence; Adequately treated carcinoma in situ (e.g., cervical, breast) with no current disease.\n* Symptomatic moderate\u002Fsevere pleural effusion or ascites.\n* Active bleeding or coagulopathy (PT \\>16s, APTT \\>43s, INR \\>1.5×ULN), bleeding tendency, or current use of thrombolytics\u002Fanticoagulants\u002Fantiplatelets.\n* GI bleeding within 6 months or high bleeding risk (e.g., active ulcer with occult blood++). If occult blood+ persists, endoscopy required.\n* High-risk esophageal\u002Fgastric varices needing intervention.\n* History of drug abuse, psychiatric disorder, or inability to abstain.\n* Solid organ\u002Fbone marrow transplant, or active autoimmune disease requiring systemic treatment within 2 years.\n* Immunodeficiency or HIV infection.\n* Objective evidence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation-\u002Fdrug-induced pneumonitis, or severely impaired pulmonary function.\n* Major surgery within 4 weeks or minor surgery within 1 week (e.g., tooth extraction).\n* Vaccination within 30 days before the first dose.\n* Abdominal fistula, GI perforation, or abscess within 4 weeks.\n* Any clinically significant abnormality affecting safety per investigator, including: Active infection requiring systemic therapy; Uncontrolled diabetes\u002Fhypertension (BP \\>140\u002F90 mmHg despite ≤2 antihypertensives); Myocardial infarction within 6 months; Thyroid dysfunction (\\>NCI CTCAE v4.0 Grade 1).\n* Other conditions deemed ineligible by the investigator.",{"count":457,"type":22},55,[25,26],"This study aims to evaluate the safety and preliminary efficacy of NALIRIFOX combined with adebrelimab and PULSAR as first-line treatment for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Additionally, it will explore potential predictive and efficacy-related biomarkers.",[461,462],"Pancreatic Ductal Adenocarcinoma (PDAC)","Locally Advanced and Metastatic Pancreatic Cancer",[464,465,466,467],"chemotherapy","immunotherapy","radiotherapy","PDAC","2026-05-16",{"date":297,"type":41},{"date":471,"type":22},"2026-04",{"date":473,"type":22},"2029-03",{"name":47,"class":48},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":133,"minAge":18,"maxAge":236,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":49},"100640698","phase-3-the-comparison-between-dedti-br-and-te-br-100640698","NCT07593846","The Comparison Between DEDTI BR and T\u002FE BR","A National Multicenter, Prospective, Cohort Study Comparing Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Axillary Approach With the Two-Stage Expander-to-Implant Breast Reconstruction Following Simple Mastectomy","DETE-BR","Inclusion Criteria:\n\n* Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer;\n* At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity;\n* Voluntary provision of informed consent.\n\nExclusion Criteria:\n\n* Local\u002Fregional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence);\n* Pectoralis major muscle was resected during the initial surgery;\n* Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery;\n* Immunodeficiency;\n* Long-term smoking history or poorly controlled diabetes mellitus;\n* Currently participating in other clinical trials that may affect the results of this study.",{"count":484,"type":22},412,[396],"This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.",[331],[331,489,490,491],"Endoscopic surgery","Minimal invasive surgery","Breast Reconstruction","2026-05-11",{"date":494,"type":41},"2026-05-18",{"date":496,"type":22},"2026-05-01",{"date":498,"type":22},"2028-12-31",{"name":47,"class":48},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":49},"100630841","phase-2-neoadjuvant-sacituzumab-govitecan-plus-tagitanlimab-for-resectable-head-and-neck-squamous-cell-carcinoma-100630841","NCT07492914","Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma","A Single-Arm, Phase II Prospective Study Of Lucanoximab Combined With Tagolimab As Neoadjuvant Therapy For Resectable Head And Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Aged 18 years and above, of any gender.\n* Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥80×10⁹\u002FL, hemoglobin ≥8 g\u002FdL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) \\>60 mL\u002Fmin; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n* Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol.\n\nExclusion Criteria:\n\n* A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).\n* Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.\n* A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.\n* Prior anti-tumor treatment involving anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.\n* Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose.\n* Systemic use of corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressants within 14 days prior to the first dose (inhaled or topical steroids and adrenal replacement therapy are permitted).\n* Severe medical conditions, including New York Heart Association (NYHA) class II or higher heart failure, ischemic heart disease, clinically significant arrhythmias requiring intervention, left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography, or prolonged QTc interval (males \\>450 msec, females \\>470 msec).\n* A known history of interstitial lung disease or high clinical suspicion of interstitial lung disease; active pulmonary tuberculosis or uncontrolled previous tuberculosis infection.\n* Hyperthyroidism or organic thyroid disease (patients with hypothyroidism under stable thyroid hormone replacement therapy are eligible for enrollment).\n* Active infection, unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within 1 week prior to signing the informed consent form.\n* Active hepatitis B (HBV DNA ≥2000 IU\u002Fml or ≥10⁴ copies\u002Fml), active hepatitis C (positive anti-HCV and HCV RNA above the lower limit of detection), positive HIV antibody, or a history of acquired immunodeficiency syndrome (AIDS).\n* A definite history of neurological or psychiatric diseases such as epilepsy or dementia.\n* A history of drug or alcohol abuse.\n* Pregnant or lactating females; patients (or their partners) planning pregnancy, having unprotected sexual intercourse, or refusing to take effective contraceptive measures during the study and for 3 months after study completion.\n* Receipt of other investigational drugs within 4 weeks prior to the first dose, or concurrent participation in other interventional clinical studies (observational or follow-up interventional studies are excluded).\n* Other circumstances deemed unsuitable for study participation by the investigator.",{"count":508,"type":22},30,[26],"The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are:\n\nDoes the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC?\n\nWhat adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy?\n\nDoes this combined therapy improve participants' objective response rate (ORR), survival time and quality of life?\n\nThis is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial.\n\nParticipants will:\n\nReceive Sacituzumab govitecan (5mg\u002Fkg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles.\n\nPatients will undergo surgical resection 3-6 weeks after completion of neoadjuvant therapy. Adjuvant therapy (concurrent chemoradiotherapy or radiotherapy alone) will be administered according to pathological risk factors, together with 15 cycles of Tagitanlimab as adjuvant immunotherapy.\n\nVisit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI\u002FCT) and safety checkups according to the study schedule.\n\nProvide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection.\n\nComplete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning.\n\nNote: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.",[512],"Resectable Head and Neck Squamous Cell Carcinoma","2026-05-10",{"date":515,"type":41},"2026-05-13",{"date":492,"type":22},{"date":518,"type":22},"2031-03-31",{"name":47,"class":48},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":537,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":550,"leadSponsor":552,"locationsCount":553},"100639849","underdilated-vcx-tips-versus-evl-plus-nsbb-for-secondary-prophylaxis-of-variceal-bleeding-in-cirrhosis-100639849","NCT07587671","Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis","Underdilated VIATORR Controlled Expansion Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Nonselective Beta-Blockers for Secondary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis: A Multicenter, Open-Label, Randomized Controlled Trial","U-TIPS","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of sex.\n* Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and\u002For clinical manifestations.\n* Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices.\n* Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase.\n* Child-Pugh score of 5 to 13.\n* The investigator judges that both underdilated VCX-TIPS and EVL plus NSBB are clinically feasible and that randomization is appropriate.\n* The participant or legally authorized representative understands the study procedures and voluntarily signs written informed consent.\n\nExclusion Criteria:\n\n* Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.\n* A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate.\n* Child-Pugh score greater than 13.\n* Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.\n* Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices.\n* Non-cirrhotic portal hypertension.\n* Cavernous transformation of the portal vein or portal venous thrombosis that makes standardized TIPS technically infeasible.\n* Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding.\n* Severe heart failure, severe pulmonary hypertension, severe tricuspid regurgitation, right heart failure, or other contraindications to TIPS.\n* Uncontrolled severe infection, sepsis, or multiple organ failure.\n* Hepatocellular carcinoma beyond the Milan criteria or other advanced malignancy.\n* Severe renal insufficiency requiring long-term renal replacement therapy.\n* Pregnancy or breastfeeding.\n* Absolute contraindication to EVL, NSBB, or TIPS.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.",{"count":394,"type":22},[108],"Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration.\n\nThe VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting.\n\nThis is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.",[532,533,534,535,536],"Liver Cirrhosis","Portal Hypertension","Gastroesophageal Varices Bleeding","Esophageal Varices","Hepatic Encephalopathy",[538,539,540,541,542,543,544,545],"Cirrhosis","Portal hypertension","Esophageal variceal bleeding","Secondary prophylaxis","Transjugular intrahepatic portosystemic shunt","Underdilation","Endoscopic variceal ligation","Hepatic encephalopathy","2026-05-07",{"date":548,"type":41},"2026-05-14",{"date":224,"type":22},{"date":551,"type":22},"2030-07-30",{"name":47,"class":48},3,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":49},"100636133","phase-1-imp3-sarna-vaccine-in-advanced-nsclc-100636133","NCT07561723","IMP3-saRNA Vaccine in Advanced NSCLC","A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of IMP3-saRNA (YMN-136) Vaccine in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients aged at least 18 years at screening who voluntarily sign an ethics committee-approved informed consent form before any study procedure and agree to participate in this study.\n2. Patients with histologically or cytologically confirmed non-small cell lung cancer who have failed standard treatment, are intolerant to standard treatment, or have refused standard treatment, and whose tumor tissue is positive for IMP3 expression. The IMP3 pathological test result must be issued by the pathology department of this hospital or by a qualified pathology institution recognized by the study center. If a previous pathology report cannot confirm IMP3 status, IMP3 testing must be performed during screening, and only patients with positive results may be enrolled.\n\n   Note:\n   1. Patients with EGFR-sensitive mutations must have failed third-line or later treatment, including failure of at least one EGFR-TKI.\n   2. Patients with ALK-positive disease must have failed third-line or later treatment, including failure of at least one ALK inhibitor.\n   3. Patients with ROS1-positive disease must have failed third-line or later treatment, including failure of at least one ROS1 inhibitor.\n   4. Patients with EGFR wild-type disease and no ALK or ROS1 positivity must have failed second-line or later treatment, including platinum-containing treatment.\n3. At least one measurable or evaluable lesion according to RECIST version 1.1.\n4. Eastern Cooperative Oncology Group performance status score of 0 to 2.\n5. Estimated life expectancy of at least 3 months.\n6. Adequate major organ function, with the following test results meeting the requirements within 7 days before treatment:\n\n   1. Hemoglobin ≥80 g\u002FL without blood transfusion within 14 days; absolute neutrophil count \\>1.5 × 10\\^9\u002FL; white blood cell count ≥3.0 × 10\\^9\u002FL; platelet count ≥80 × 10\\^9\u002FL.\n   2. Total bilirubin ≤1.5 × upper limit of normal; alanine aminotransferase or aspartate aminotransferase ≤2.5 × upper limit of normal; in patients with liver metastasis, alanine aminotransferase or aspartate aminotransferase ≤5 × upper limit of normal.\n   3. Serum creatinine ≤1.5 × upper limit of normal or creatinine clearance estimated by the Cockcroft-Gault formula ≥60 mL\u002Fmin.\n   4. Prothrombin time and international normalized ratio ≤1.5 × upper limit of normal, unless the patient is receiving warfarin anticoagulation.\n   5. Cardiac function: left ventricular ejection fraction ≥50%; QTcF interval ≤450 ms.\n7. Male patients with reproductive potential and female patients of childbearing potential voluntarily agree to use effective contraception, such as condoms, intrauterine devices, or spermicides, from signing the informed consent form until 6 months after completion of vaccination. Oral contraceptives are not allowed. Female cancer patients must have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after administration of the investigational vaccine.\n8. The washout period for previous antitumor therapy must be no less than 4 weeks, and the washout period for molecular targeted therapy must be no less than 5 half-lives. Palliative radiotherapy must have been completed for at least 2 weeks; thoracic radiotherapy must have been completed for at least 3 months; and major surgery must have been completed with at least 4 weeks of recovery.\n\nExclusion Criteria:\n\n1. Patients with a history of other malignancies, except for malignancies considered eligible by the investigator, such as cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or intramucosal gastrointestinal carcinoma without recurrence within 5 years before screening.\n2. Any uncontrolled clinical disease, such as respiratory, circulatory, digestive, neurologic, hematologic, genitourinary, or endocrine disease, or psychiatric disease, such as depression or schizophrenia, or other major disease that, in the investigator's judgment, may interfere with provision of informed consent, interfere with interpretation of study results, pose a risk to the participant by participating in this study, or otherwise affect achievement of the study objectives.\n3. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurologic disease, multiple sclerosis, autoimmune demyelinating neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome, except type 1 diabetes mellitus controlled with a stable dose of insulin. Participants with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled; participants with asthma requiring medical intervention with bronchodilators are not eligible.\n4. Patients with active central nervous system metastases, including but not limited to carcinomatous meningitis and spinal cord compression, must be excluded. However, patients with metastatic central nervous system tumors may participate in this study if they have recovered to baseline for at least 2 weeks before enrollment, with no residual signs or symptoms related to central nervous system treatment. In addition, patients must have discontinued corticosteroids for 4 weeks.\n5. Allergy to the study drug, including any excipients. History of severe allergy to any drug, food, or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reaction, such as Arthus reaction.\n6. Contraindications to injection: a. inflammation, trauma, or ulceration at the injection site; b. severe bleeding or coagulation tendency, or marked decrease in platelets or coagulation factors; c. any abnormality or permanent body art, such as a tattoo, at the vaccination site that, in the investigator's judgment, may interfere with observation of local reactions at the vaccination site.\n7. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.\n8. Prior antitumor therapeutic vaccine or cellular immunotherapy.\n9. Participation in another drug or device clinical trial within 4 weeks before screening.\n10. Major surgery within 4 weeks before the first vaccination, except for minor procedures such as catheter placement or protocol-required biopsy; or insufficient resolution of the effects of surgery or trauma for at least 14 days before enrollment.\n11. Participants who have received systemic treatment with corticosteroids at a dose \\>10 mg\u002Fday prednisone or an equivalent dose of another glucocorticoid, or other immunosuppressive agents, within 14 days before the first vaccination. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement therapy at a dose ≤10 mg\u002Fday prednisone equivalent are allowed.\n12. Any toxicity caused by previous antitumor therapy has not recovered to grade ≤1 according to NCI CTCAE version 5.0 before the first administration of the study drug, except for alopecia of any grade and grade 2 neuropathy related to prior platinum therapy.\n13. Known hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis infection, or positive screening test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, HIV antibody, or Treponema pallidum antibody: HBsAg positivity or HBcAb positivity with HBV DNA quantitative test result ≥500 IU\u002FmL or ≥2000 copies\u002FmL, or meeting the lower limit of positivity at the study center; HCVAb positivity with HCV RNA ≥ the upper limit of normal at the study center.\n14. Active tuberculosis, history of active tuberculosis, or severe acute or chronic infection requiring systemic treatment. Patients suspected of having active tuberculosis must undergo chest X-ray, sputum testing, and exclusion by clinical symptoms and signs. Patients with objective evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function are excluded.\n15. History of drug abuse or known medical, psychological, or social conditions, such as alcoholism or drug addiction.\n16. Pregnant or breastfeeding women, or female participants who plan to become pregnant or male participants whose partners plan to become pregnant from screening until 12 months after completion of all study drug injections.\n17. Receipt of any vaccine within 30 days before vaccination with the study vaccine, or planned receipt of any vaccine other than the study vaccine during the study.\n18. History of deep vein thrombosis or pulmonary embolism within 6 months before enrollment.\n19. Uncontrolled fungal, bacterial, viral, or other infection requiring antibiotic treatment. Simple urinary tract infection or uncomplicated bacterial pharyngitis may be allowed after consultation with the medical monitor.\n20. History or presence of central nervous system disease, such as seizure disorder, cerebral ischemia or hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system.\n21. Significant immunodeficiency.\n22. Negative tumor tissue IMP3 pathological test result or inability to obtain or confirm IMP3 status.\n23. Any other factor that, in the investigator's judgment, makes the participant unsuitable for this study, or any disease that may interfere with safety or efficacy evaluation of the study treatment.\n24. Participants who are unwilling or unable to comply with study requirements.",{"count":86,"type":22},[25],"This is an open-label, single-arm, non-randomized, single-center, prospective phase 1 clinical trial. The study will evaluate the safety, tolerability, and preliminary antitumor activity of IMP3-saRNA (YMN-136) vaccine in patients with advanced non-small cell lung cancer.\n\nIMP3-saRNA (YMN-136) is a vaccine product prepared from IMP3 self-amplifying RNA and lipid nanoparticles. The study will enroll patients with histologically or cytologically confirmed non-small cell lung cancer who have failed standard treatment, are intolerant to standard treatment, or have refused standard treatment, and whose tumor tissue is positive for IMP3 expression.\n\nA total of 9 participants are planned to be enrolled. Participants will enter one of three dose groups sequentially: 50 micrograms, 100 micrograms, or 200 micrograms. Each dose group will include 3 participants. The study will use a 3+3 dose-escalation design. The vaccine will be administered by intramuscular injection. The immunization schedule includes 4 doses, with each dose given 3 weeks apart.\n\nThe main purpose of the study is to assess safety and tolerability. Dose-limiting toxicity will be assessed from the first vaccination until 14 days after the third vaccination. Safety assessments will include adverse events, serious adverse events, physical examinations, vital signs, ECOG performance status, laboratory tests, 12-lead electrocardiogram, and echocardiography.\n\nThe study will also preliminarily assess antitumor activity using RECIST version 1.1. Imaging assessments may include CT or MRI and whole-body bone scan. Additional exploratory evaluations may include blood and tumor tissue biomarker analyses, such as ctDNA, tumor markers, immune cell subsets, dendritic cell maturation, antigen-specific cytotoxic T cells, T-cell activation, antibody titers, PD-L1 expression, gene mutation analysis, and other immune-related tests.",[565],"Non-Small Cell Lung Cancer",{"date":567,"type":41},"2026-05-12",{"date":569,"type":22},"2026-04-30",{"date":571,"type":22},"2029-04-30",{"name":47,"class":48},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"locationsCount":49},"100636557","phase-1-clinical-study-of-cfh-protein-via-ice-microneedles-for-radiation-induced-skin-fibrosis-100636557","NCT07567235","Clinical Study of CFH Protein Via Ice Microneedles for Radiation-Induced Skin Fibrosis","A Clinical Study to Evaluate the Safety and Tolerability of Intradermal Delivery of CFH Protein Via Ice Microneedles for the Prevention of Radiation-Induced Skin Fibrosis","Inclusion Criteria:\n\n1. Male or female patients aged 18 to 75 years (inclusive) at screening.\n2. Histologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) scheduled to receive postoperative adjuvant radiotherapy.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n4. Adequate major organ function within 7 days before treatment, meeting the following criteria:\n\n   Hemoglobin ≥ 80 g\u002FL; neutrophil count \\> 1.5 × 10⁹\u002FL; platelet count ≥ 80 × 10⁹\u002FL; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT or AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN (unless on warfarin anticoagulation); Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Ability to understand and voluntarily sign a written informed consent form prior to any study procedures.\n\nExclusion Criteria:\n\n1. Presence of ulceration or open wound in the treatment area, or any contraindication to cutaneous administration including: Inflammation, trauma, or skin breakdown at the administration site; Severe bleeding or coagulation tendency (e.g., markedly low platelet or clotting factors); Any abnormality or permanent body art (e.g., tattoo) at the administration site that would interfere with observation of local reactions;\n2. Presence of connective tissue disease or other systemic dermatologic conditions (e.g., systemic lupus erythematosus, dermatomyositis, polymyositis, systemic sclerosis, scleroderma, toxic epidermal necrolysis, Stevens-Johnson syndrome, etc.).\n3. Known allergy to the investigational drug (including any excipients) or history of severe allergic reactions to any drug, food, or vaccine, such as anaphylactic shock, laryngeal edema, anaphylactic dyspnea, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction.\n4. Any uncontrolled clinical disease (e.g., respiratory, circulatory, digestive, nervous, hematologic, genitourinary, or endocrine system disease) or psychiatric disorder (e.g., depression, schizophrenia) that, in the investigator's judgment, would interfere with providing informed consent, interpretation of study results, pose additional risk to the patient, or otherwise compromise study objectives.\n5. Participation in another clinical trial of a drug or device within 3 months prior to screening.\n6. History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism or drug addiction).\n7. Pregnant or breastfeeding women, or women\u002Fpartners planning pregnancy during the period from screening through 12 months after the last dose.\n8. Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.",{"count":86,"type":22},[25],"This phase I, open-label, single-arm, non-randomized clinical trial uses a \"3+3\" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of intradermal delivery of complement factor H (CFH) fragment (human, 860-1231aa) via ice microneedles for the prevention of radiation-induced skin fibrosis in patients with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) receiving postoperative adjuvant radiotherapy. The main questions are: 1. The safety profile, including dose-limiting toxicities (DLTs) within 28 days after the first dose, adverse events, and tolerability. 2.Preliminary efficacy, assessed by changes in irradiated skin thickness, palpation of fibrotic area, CTCAE grade ≤2 fibrosis rate, and quality of life. Participants receive CFH ice microneedle patches twice weekly for a total of 8 doses (starting at 0.5 mg, escalating to 1.0 mg and 2.0 mg), applied to the skin area to be irradiated.",[584,585],"Radiation-Induced Skin Fibrosis","Head and Neck Squamous Cell Carcinoma","2026-05-06",{"date":492,"type":41},{"date":443,"type":22},{"date":590,"type":22},"2027-03-01",{"name":47,"class":48},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":236,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":607,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":4},"100639231","phase-1-safety-tolerability-and-preliminary-antitumor-activity-of-cationic-peptide-il22bp-mrna-in-advanced-solid-tumors-100639231","NCT07583654","Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors","A Clinical Trial of Cationic Peptide-IL22BP mRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years and ≤70 years.\n* Histopathologically confirmed advanced recurrent\u002Fmetastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected overall survival ≥3 months.\n* Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.\n* Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.\n* Adequate organ function, defined by the following laboratory parameters within 14 days prior to enrollment:\n* Hemoglobin ≥90 g\u002FL (no blood transfusion within 14 days).\n* Absolute neutrophil count \\>1.5 × 10⁹\u002FL.\n* Platelet count ≥80 × 10⁹\u002FL.\n* Total bilirubin ≤1.5 × upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × -ULN in case of liver metastasis).\n* Creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Participation in another investigational drug clinical trial within 4 weeks.\n* Tumor located adjacent to major blood vessels or trachea.\n* Uncontrolled cardiac clinical symptoms or diseases, including New York Heart Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular\u002Fventricular arrhythmias requiring treatment or intervention.\n* Female patients who are pregnant or lactating.\n* Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.\n* History of uncontrollable psychoactive substance abuse or presence of mental disorders.\n* Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism.\n* Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.\n* Receiving immunosuppressive therapy.\n* History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).\n* Known hypersensitivity, allergy, or intolerance to the study drug CPIL22BP mRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).\n* Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.\n* Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.",{"count":600,"type":22},18,[25],"The goal of this phase 1 clinical trial is to evaluate the safety, tolerability, and preliminary antitumor activity of a peptide-delivered IL-22BP biotherapy in patients with advanced solid tumors. The main questions it aims to answer are:\n\nIs the IL-22BP formulation safe and tolerable? Does the IL-22BP formulation show preliminary antitumor activity?",[139,604,605,606],"Solid Tumor Cancer","Peptides","Cancer Metastatic",[141,608,609,610],"Cancer metastasis","Solid tumor","IL-22",{"date":515,"type":41},{"date":613,"type":22},"2026-05-30",{"date":615,"type":22},"2027-12-30",{"name":47,"class":48},""]