[{"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:":584},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,204,0,25,[9,42,69,96,118,138,157,177,195,214,238,257,279,298,321,343,370,393,423,454,479,500,520,545,564],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652584","phase-2-phase-ii-study-of-subretinal-jwk001-for-neovascular-age-related-macular-degeneration-100652584",false,"NCT07776522","Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration","A Phase II Study to Evaluate the Safety and Preliminary Efficacy of Subretinal Administration of JWK001 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Written informed consent and ability to comply with the study protocol.\n2. Male or female, aged 50-85 years.\n3. Active subfoveal MNV secondary to nAMD requiring anti-VEGF treatment.\n4. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;\n5. Study-eye BCVA of 19-78 ETDRS letters.\n6. Pseudophakic study eye.\n\nExclusion Criteria:\n\n1. Any ocular condition other than nAMD that may affect vision, study assessments, treatment safety, or interpretation of results.\n2. Intraocular surgery or intraocular corticosteroid treatment within 4 weeks at screening.\n3. Any ocular condition making the study eye unsuitable for subretinal injection.\n4. Active ocular infection or inflammation, or a history of idiopathic or autoimmune uveitis.\n5. Monocular status or non-study-eye BCVA \\\u003C19 ETDRS letters.\n6. Clinically significant systemic disease or infection, malignancy, prohibited concomitant treatment, prior gene therapy, or recent participation in another clinical trial.\n7. Any other condition considered by the investigator to make the subject unsuitable for participation.","ALL","50 Years","85 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase II, randomized, open-label, active-controlled study designed to evaluate the preliminary efficacy and safety of a single subretinal administration of JWK001 at different dose levels in patients with neovascular age-related macular degeneration.",[28],"Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD","RECRUITING","2026-08-17",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":22},"2026-08-31",{"date":37,"type":22},"2032-01-14",{"name":39,"class":40},"West China Hospital","OTHER",16,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100652546","personalized-ctdna-monitoring-for-predicting-immunotherapy-outcomes-in-advanced-non-clear-cell-renal-cell-carcinoma-100652546","NCT07776483","Personalized ctDNA Monitoring for Predicting Immunotherapy Outcomes in Advanced Non-Clear Cell Renal Cell Carcinoma","Patient-Specific Circulating Tumor DNA Monitoring for Prediction of Immunotherapy Response and Prognostic Stratification in Advanced Non-Clear Cell Renal Cell Carcinoma: A Prospective Observational Cohort Study","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age 14 years or older, with no restriction based on sex.\n2. Histologically confirmed renal cell carcinoma classified as non-clear cell renal cell carcinoma. Immunohistochemical or molecular testing may be used when necessary to establish the histological subtype. Eligible subtypes include papillary renal cell carcinoma, chromophobe renal cell carcinoma, TFE3-rearranged renal cell carcinoma, FH-deficient renal cell carcinoma, collecting duct carcinoma, renal medullary carcinoma, and other rare non-clear cell renal cell carcinoma subtypes.\n3. Unresectable or metastatic renal cell carcinoma with at least one measurable lesion according to RECIST version 1.1.\n4. Scheduled, according to routine clinical care, to initiate immune checkpoint inhibitor-based systemic therapy, including an immune checkpoint inhibitor combined with targeted therapy, dual immune checkpoint blockade, or immune checkpoint inhibitor monotherapy. The number of previous lines of systemic therapy is not restricted, provided that prior treatment history, specific regimens, and best responses can be adequately documented.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and an estimated life expectancy greater than 3 months.\n6. Ability and willingness to provide written informed consent and comply with protocol-specified sample collection, examinations, and follow-up.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. The planned systemic treatment does not contain an immune checkpoint inhibitor and consists only of chemotherapy, targeted therapy, or another non-immunotherapy systemic treatment.\n2. Untreated, symptomatic, or clinically unstable central nervous system metastases or leptomeningeal metastases.\n3. Another active malignancy of a different primary site or histological type within the previous 3 years, except adequately controlled malignancies such as papillary thyroid carcinoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n4. Major surgery or severe trauma within 4 weeks before enrollment without adequate recovery.\n5. Uncontrolled severe infection or another serious comorbidity, including active tuberculosis, active hepatitis B or C, severe cardiac insufficiency, persistent symptomatic arrhythmia, uncontrolled hypertension, or serious cardiovascular or cerebrovascular events such as myocardial infarction, unstable angina, or cerebrovascular accident within 6 months before enrollment.\n6. Pregnancy or breastfeeding.\n7. Severe psychiatric, cognitive, or behavioral impairment that prevents understanding of the study, provision of required samples, or completion of protocol-specified examinations and follow-up.\n8. Failure to establish a patient-specific ctDNA monitoring panel because of inadequate tumor tissue quantity or quality, inability to identify suitable patient-specific somatic variants, or other technical reasons.\n9. Any other condition that, in the investigator's judgment, may increase the risks associated with study participation, interfere with interpretation of the study results, or compromise protocol compliance.","14 Years","75 Years",{"count":52,"type":22},67,"OBSERVATIONAL","This is a prospective, non-interventional observational cohort study evaluating the clinical utility of patient-specific circulating tumor DNA (ctDNA) monitoring in patients with advanced non-clear cell renal cell carcinoma (nccRCC) receiving immune checkpoint inhibitor-based systemic therapy. Tumor-informed personalized ctDNA assays will be developed based on tumor tissue and matched normal blood samples, and ctDNA will be longitudinally assessed at predefined time points during treatment. The primary objectives are to evaluate the associations of baseline ctDNA status with progression-free survival and objective response rate. Secondary and exploratory analyses will assess overall survival, disease control, duration of response, longitudinal ctDNA dynamics, radiographic tumor burden, and molecular progression.",[56],"Non-Clear Cell Renal Cell Carcinoma",[58,56,59,60,61],"Circulating Tumor DNA","Immune Checkpoint Inhibitor","Personalized ctDNA Monitoring","Liquid Biopsy","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":65,"type":22},"2026-09-01",{"date":67,"type":22},"2028-12-30",{"name":39,"class":40},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100606425","phase-1-jdb153-combined-with-serplulimab-for-pancreatic-cancer-after-standard-treatment-failure-100606425","NCT07175389","JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure","A Phase Ib\u002FII Clinical Trial of JDB153 Combined With Serplulimab for the Treatment of Pancreatic Cancer Refractory to Standard Therapy","Inclusion Criteria:\n\n* 1\\) Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer; 2) Age 18-75 years, inclusive; no sex restrictions; 3) Life expectancy ≥12 weeks; 4) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5) Documented disease progression following prior standard systemic therapy. For patients who experienced disease progression within 6 months during or after adjuvant chemotherapy, the adjuvant chemotherapy will be considered first-line treatment; 6) Presence of at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Target lesions must have a maximum diameter of ≥1 cm if identified by helical computed tomography (CT) or ≥2 cm if identified by conventional CT or magnetic resonance imaging (MRI). All imaging must have been performed within 28 days prior to enrollment; 7) Adequate bone marrow and organ function, as evidenced by laboratory test results obtained within 1 week prior to enrollment: Hemoglobin ≥90 g\u002FL; Platelet count ≥75 × 10⁹\u002FL; White blood cell count ≥3.0 × 10⁹\u002FL; Absolute neutrophil count ≥1.5 × 10⁹\u002FL; Total bilirubin ≤1.5 × upper limit of normal (ULN)(or ≤ 3.0 × ULN for patients with documented liver metastases); Serum creatinine ≤1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (or ≤ 5.0 × ULN for patients with documented liver metastases). Patients must not have received blood transfusions, granulocyte colony-stimulating factor (G-CSF), or other medical supportive treatments within 14 days prior to study drug administration; 8) Voluntary participation with provision of written informed consent.\n\nExclusion Criteria:\n\n* 1\\) History of other malignant tumors with disease-free survival \\\u003C5 years (except cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection); 2) Prior treatment with a PD-1or PD-L1inhibitor; 3) Presence of immunodeficiency disease or HIV infection; 4) Severe, uncontrolled acute infection (defined as fever \\>38°C caused by infection); 5) History of active hepatitis B or active hepatitis C, defined as: HBV DNA titer ≥2000 IU\u002FmL (or 1×10⁴ copies\u002FmL) or HCV RNA ≥lower limit of detection; 6) Severe hepatic or renal dysfunction; or recent history of myocardial infarction (within 3 months); 7) Patients with active or previous autoimmune disease that has the potential for recurrence or poses associated risks (e.g., those who have undergone organ transplantation requiring immunosuppressive therapy). However, patients with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin diseases not necessitating systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are permitted to enroll; 8) History of interstitial lung disease or non-infectious pneumonitis that is symptomatic or has a history of pulmonary disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity; 9) History of active tuberculosis infection within 1 year prior to first administration of study drug. However, for patients with a history of active tuberculosis infection more than 1 year ago, enrollment is considered appropriate if the investigator determines there is currently no evidence of active tuberculosis; 10) History of chronic diarrhea or presence of complete intestinal obstruction; 11) Patients requiring systemic treatment with corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drug. Note: Inhaled or topical steroids, or adrenal replacement therapy (≤10 mg\u002Fday prednisone equivalent), are permitted in the absence of active autoimmune disease. Short-term (≤7 days) use of corticosteroids for prophylactic treatment (e.g., contrast media allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions caused by contact allergens) is permitted; 12) Concurrent other serious medical or surgical conditions affecting organ function that the investigator considers inappropriate for participation in this clinical trial; 13) Participation in other investigational drug clinical trials within 4 weeks; 14) Pregnant or lactating women, or patients with reproductive potential (men or women who have been post-menopausal for less than 1 year) who are unwilling to use adequate contraceptive measures; 15) Patients with a history of allergic or hypersensitivity reactions to any study drug components; 16) Patients deemed inappropriate for participation in this clinical trial by the investigator.","18 Years",{"count":78,"type":22},10,[80,25],"PHASE1","The goal of this clinical trial is to evaluate the safety and efficacy of JDB153 combined with Serplulimab in patients with pancreatic cancer after standard treatment failure.",[83,84],"Refractory Pancreatic Ductal Adenocarcinoma","Refractory Pancreatic Adenocarcinoma",[86,87,88],"Pancreatic Cancer","JDB153","Serplulimab",{"date":90,"type":33},"2026-08-19",{"date":65,"type":22},{"date":93,"type":22},"2028-12-01",{"name":39,"class":40},1,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":95},"100651860","online-sharing-for-head--neck-cancer-support-100651860","NCT07766226","Online Sharing for Head & Neck Cancer Support","A Prospective Randomized Controlled Trial of Network Platform Sharing Intervention for Psychological Outcomes in Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy","Inclusion Criteria:\n\n1. Age 18 - 75 years, male or female\n2. Life expectancy ≥ 6 months\n3. Histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) without distant metastasis\n4. Planned to receive curative radiotherapy or postoperative adjuvant radiotherapy\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n6. Adequate cognitive and reading ability to complete questionnaires\n7. Ability to use a smartphone or tablet device\n8. Fluent in Chinese (reading and speaking)\n9. Willing and able to provide signed informed consent\n\nExclusion Criteria:\n\n1. Other malignancies (except treated basal cell skin cancer or cervical CIS)\n2. Prior head and neck radiotherapy\n3. History of psychiatric disorder or psychotropic medication use\n4. Absolute contraindication to head and neck radiotherapy\n5. Uncontrolled systemic disease (poorly controlled DM, NYHA III-IV HF, interstitial lung disease)",{"count":104,"type":22},120,[106],"NA","Head and neck cancer patients often experience significant anxiety and depression during radiation therapy, which can affect their quality of life and treatment adherence. However, traditional psychological support is limited by resource constraints and accessibility. This study aims to evaluate whether a mobile application based on social sharing and peer interaction can improve psychological distress in patients with head and neck squamous cell carcinoma (HNSCC) undergoing radiotherapy.\n\nThis is a prospective, randomized, parallel-group, open-label trial. A total of 120 participants will be randomly assigned in a 1:1 ratio to either the immediate intervention group or a waitlist control group. Participants in the intervention group will use a dedicated app featuring daily sharing, peer interaction (anonymous comments, likes, private messaging), psychoeducational resources, and reminders. The control group will receive a printed psychoeducational booklet during the initial phase and will gain access to the app after the primary endpoint assessment.\n\nThe primary outcome is the change in anxiety score (HADS-A) from baseline to completion of radiotherapy. Secondary outcomes include depression scores (HADS-D), radiotherapy interruption rate, app engagement, and severe psychological distress prevalence. Exploratory outcomes include quality of life (EORTC QLQ-C30, H\\&N35), readmission rate, adverse event severity (CTCAE v5.0), and biological markers (e.g., cortisol, IL-6, CRP).\n\nThe study is expected to run from April 2026 to August 2027. Findings may inform scalable digital psychosocial interventions for cancer patients.",[109],"Head and Neck Squamous Cell Carcinoma","2026-08-10",{"date":112,"type":33},"2026-08-14",{"date":114,"type":22},"2026-08-01",{"date":116,"type":22},"2028-02-01",{"name":39,"class":40},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":95},"100651641","phase-1-ymn-136-vaccine-for-patients-with-advanced-hepatobiliary-and-pancreatic-malignancies-100651641","NCT07763301","YMN-136 Vaccine for Patients With Advanced Hepatobiliary and Pancreatic Malignancies","YMN-136 Vaccine for Patients With Advanced Hepatobiliary and Pancreatic Malignancies: A Prospective, Phase I Clinical Trial","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, and be able to understand and agree to comply with the study procedures and visits as specified in the protocol.\n2. Age: 18 to 75 years old, male or female.\n3. Patients with pathologically or histologically confirmed, unresectable advanced hepatobiliary and pancreatic malignancies who must have experienced disease progression after receiving standard anti-tumor therapy, or who are unable to receive or tolerate standard therapy, or who refuse standard therapy:\n\n(1) Patients with advanced hepatocellular carcinoma who have failed standard therapy, defined as disease progression after prior treatment with PD-(L)1 and mTKI systemic therapy (either separately or in combination), or discontinuation of treatment due to intolerance to toxicity; (2) Patients with advanced biliary tract cancer who have failed standard therapy, defined as disease progression after prior treatment with gemcitabine-containing systemic therapy and non-cytotoxic therapy (i.e., targeted therapy or immunotherapy), or discontinuation of treatment due to intolerance to toxicity; (3) Patients with advanced pancreatic cancer who have failed standard therapy, defined as disease progression after prior treatment with at least two systemic therapies (must include fluoropyrimidines and gemcitabine), or discontinuation of treatment due to intolerance to toxicity.\n\n4\\. Positive IMP3 expression. 5. At least one evaluable lesion according to RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. 7. Life expectancy ≥ 12 weeks. 8. Organ function levels at screening must meet the following requirements:\n\n1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n2. Platelet count (PLT) ≥ 75 × 10⁹\u002FL;\n3. Hemoglobin (Hb) ≥ 90 g\u002FL;\n4. Total bilirubin (TBIL) ≤ 1.5 × ULN;\n5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in patients with liver metastases;\n6. Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (Cockcroft-Gault formula) ≥ 45 mL\u002Fmin;\n7. International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN;\n8. QTc interval calculated by Fridericia's formula ≤ 450 ms for males and ≤ 470 ms for females;\n9. Urinalysis\u002F24-hour urine protein quantification: urine protein qualitative ≤ 1+ (if urine protein qualitative ≥ 2+, 24-hour urine protein \\\u003C 1 g is acceptable for enrollment);\n10. Cardiac function: left ventricular ejection fraction ≥ 50%. 9. Eligible patients (male or female) with childbearing potential must agree to use a medically accepted physical contraceptive method (e.g., intrauterine device, condom, tubal or vas deferens ligation, etc.) during the study period and for 6 months after the last dose. Female patients of childbearing potential must have a negative serum or urine HCG test at screening.\n\nExclusion Criteria:\n\n1. Presence of extensive peritoneal metastasis or intestinal obstruction.\n2. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n3. Known allergy to any component of the investigational drug (e.g., lipid nanoparticles, RNA carrier) or to drugs of the same class.\n4. Prior receipt of vaccine therapy.\n5. Received chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose.\n6. In the dose-escalation and dose-expansion phases: received anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biological therapy, or other investigational drug therapy for target lesions) within 4 weeks or 5 drug half-lives (whichever is shorter, but at least 14 days) prior to the first dose; or received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 14 days prior to the first dose.\n7. Use of immunosuppressive drugs within 4 weeks prior to the first dose or expected use during the study period, except for corticosteroid nasal sprays, inhalers, or systemic prednisone ≤ 10 mg\u002Fday (or equivalent doses of similar drugs).\n8. History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.\n9. Receipt of a live attenuated vaccine within 28 days prior to the first dose.\n10. In the dose-escalation and dose-expansion phases: presence of symptomatic, untreated, or central nervous system (CNS) metastases requiring ongoing treatment (including corticosteroids and antiepileptics). Patients with previously treated CNS metastases may be enrolled if they have been clinically stable for at least 4 weeks prior to enrollment, have no evidence of new or enlarging metastases, and have discontinued corticosteroid therapy. Patients with asymptomatic CNS metastases not requiring treatment may be enrolled.\n11. In the dose-escalation and dose-expansion phases: toxicity from prior anti-tumor therapy that has not recovered to baseline or to Grade 0-1 per NCI-CTCAE v5.0 (except for alopecia and hyperpigmentation). Irreversible toxicities that are reasonably not expected to be exacerbated by the study drug may be enrolled after confirmation with the investigator.\n12. History of autoimmune diseases, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, etc. Patients with type I diabetes mellitus, hypothyroidism controlled with replacement therapy only, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) may be enrolled.\n13. History of immediate hypersensitivity reactions, eczema, or asthma that cannot be controlled with topical corticosteroids.\n14. History of other malignancies, except for curatively treated curable tumors, such as basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n15. Presence of uncontrolled comorbid conditions, including but not limited to: unexplained fever \\> 38.5°C (patients with tumor-related fever to be enrolled at the investigator's discretion); symptomatic congestive heart failure of New York Heart Association (NYHA) class ≥ 2; left ventricular ejection fraction (LVEF) \\\u003C 50%; poorly controlled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after treatment, and assessed as clinically significant by the investigator); unstable angina or acute myocardial infarction within 3 months prior to the first dose; poorly controlled arrhythmia; chronic obstructive pulmonary disease, asthma, or interstitial lung disease with impaired pulmonary function.\n16. Presence of active infection currently requiring systemic anti-infective therapy; patients with active tuberculosis.\n17. Known positive for human immunodeficiency virus (HIV) or active syphilis infection; HBsAg and\u002For HBcAb positive with HBV-DNA \\> 500 IU\u002FL; HCV-RNA positive.\n18. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study, including but not limited to any disease or medical history that may confound the study results or interfere with patient compliance.",{"count":126,"type":22},9,[80],"This study aims to determine the safety and maximum tolerated dose (MTD) of YMN-136 vaccine through a dose escalation trial, and to investigate whether YMN-136 vaccine can assist in the treatment of patients with advanced hepatobiliary and pancreatic malignancies.",[130,86,131],"Liver Cancer","Biliary Tract Cancer (BTC)",{"date":133,"type":33},"2026-08-13",{"date":114,"type":33},{"date":136,"type":22},"2028-05-31",{"name":39,"class":40},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100597021","phase-1-pd-1-mrna-lnp-vaccine-for-advanced-primary-hepatocellular-carcinoma-100597021","NCT07053072","PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.","A Prospective，Single Arm Clinicial Trial Evaluating PD-1 mRNA LNP Vaccine for the Treatment of Advanced Primary Hepatocellular Carcinoma Failing Standard Therapy","Inclusion Criteria:\n\n1. Male or female patients: ≥18 years of age; ≤70 years of age;\n2. Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.\n3. Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm and a layer thickness of no more than 5mm);\n4. ECOG physical condition score: 0 to 1;\n5. Expected survival ≥ 3 months;\n6. Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:\n\n   * Routine blood tests: hemoglobin ≥80g\u002FL (no blood transfusion within 14 days); neutrophil count \\>1.5×109 \u002FL; platelet count ≥80×109 \u002FL;\n   * Biochemical tests: total bilirubin ≤1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN; endogenous creatinine clearance ≥ 60 ml\u002Fmin (Cockcroft-Gault formula);\n   * cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) (LVEF) ≥50%.\n7. Good compliance and family agreement to cooperate in receiving survival follow-up.\n\nExclusion Criteria:\n\n1. Participation in a clinical trial of another drug within 4 weeks;\n2. Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or other malignancies that have undergone radical therapy (at least 5 years prior to enrollment);\n3. Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial infarction within 1 year, clinically significant Supraventricular or ventricular arrhythmias requiring treatment or intervention.\n4. For female subjects: women who are pregnant or breastfeeding.\n5. Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.\n6. Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;\n7. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to : uveitis, enteritis, pituitary gland inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has resolved completely in childhood and does not require any intervention in adulthood may be enrolled; subjects with asthma requiring medical intervention with bronchodilators may not be enrolled).\n8. Patients who have been inoculated with mRNA drugs.\n9. Participation in clinical trials involving lipid nanoparticles, a component of the study vaccine.\n10. Contraindications to intramuscular injection.\n11. History of substance abuse or known medical, psychological or social conditions such as alcohol or drug abuse.\n12. Known allergy, hypersensitivity or intolerance to the investigational vaccine (including any excipients). Previous history of severe allergy to any drug, food, or vaccination, such as anaphylaxis, allergic laryngeal edema, allergic dyspnea, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction).\n13. The female subject is planning to become pregnant or the male subject's partner is planning to become pregnant during the Screening Period and up to 12 months after the full course of drug administration.\n14. In the judgment of the investigator, there is a serious concomitant disease that jeopardizes the patient's safety or interferes with the patient's ability to complete the study.","70 Years",{"count":126,"type":22},[80],"Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy",[130],{"date":133,"type":33},{"date":152,"type":33},"2025-10-23",{"date":154,"type":22},"2026-12-30",{"name":39,"class":40},2,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100651057","dietary-arginine-deprivation-combined-with-chemoradiotherapy-for-neoadjuvant-treatment-of-rectal-cancer-a-randomized-controlled-trial-100651057","NCT07755124","Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial","A Randomized Controlled Trial of Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Signed written informed consent prior to any study-related procedures.\n* Male or female, aged 18 to 80 years.\n* Locally advanced mid-low rectal cancer staged as cT3, cT4, or node-positive by rectal MRI.\n* ECOG performance status 0-1.\n* NRS-2002 score \\\u003C 3.\n* BMI ≥ 18.5 kg\u002Fm² (may be adjusted based on actual conditions).\n* Able to take food orally or via feeding tube and tolerate enteral nutrition.\n* Adequate organ function as defined by the following laboratory criteria:\n\n  1. ANC ≥ 1.5 × 10⁹\u002FL (no G-CSF within 14 days);\n  2. Platelet count ≥ 100 × 10⁹\u002FL;\n  3. Hemoglobin ≥ 9 g\u002FdL (no transfusion or erythropoietin within 7 days);\n  4. Serum albumin ≥ 3.0 g\u002FdL;\n  5. Total bilirubin ≤ 1.5 × ULN;\n  6. AST\u002FALT ≤ 2.5 × ULN;\n  7. Creatinine clearance ≥ 50 mL\u002Fmin or serum creatinine ≤ 1.5 × ULN;\n  8. INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN;\n  9. Urine protein \\\u003C 2+ (if ≥ 2+, 24-hour urine protein \\\u003C 2.0 g allowed);\n  10. Cardiac enzyme profile within normal limits.\n* Women of childbearing potential must agree to use reliable contraception from signing informed consent to at least 6 months after the last dose, with a negative serum HCG test within 3 days before treatment and non-lactating status.\n* All participants at risk of pregnancy must use contraceptive methods with a failure rate of \\\u003C 1% per year throughout treatment until 120 days after the last study drug dose (or 180 days after the last chemotherapy).\n\nExclusion Criteria:\n\n* Stage I or IV rectal cancer.\n* Cognitive impairment or psychiatric disorders that interfere with understanding the study content.\n* Central nervous system or meningeal metastases.\n* Clinically symptomatic moderate or severe ascites (requiring therapeutic paracentesis within 2 weeks before starting study treatment; patients with minimal asymptomatic ascites on imaging may be enrolled).\n* Uncontrolled or moderate to severe pleural effusion and pericardial effusion.\n* Severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess; gastrointestinal bleeding with CTCAE grade ≥ 3 within 6 months or CTCAE grade ≥ 2 within 3 months before study treatment.\n* Other factors that may affect study results or cause forced termination (as judged by the investigator), such as alcoholism, drug abuse, other serious diseases requiring combined treatment (including psychiatric disorders), severe laboratory abnormalities, family or social factors, and other conditions that may affect patient safety or study data collection.\n* Known allergy to active ingredients or excipients of the study drug or nutritional powder.\n* Poorly controlled diabetes mellitus.\n* Severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment; poorly controlled symptomatic cardiac diseases, such as unstable angina, NYHA class ≥ II heart failure, LVEF \\\u003C 50% on echocardiography, or severe arrhythmia uncontrolled by medication.\n* Pregnancy or lactation.\n* Other conditions deemed unsuitable for enrollment by the investigator.","80 Years",{"count":166,"type":22},140,[80,25],"This study evaluates whether an arginine-free diet combined with chemoradiotherapy can improve treatment outcomes in patients with locally advanced rectal cancer. Our previous study showed that an arginine-free diet is safe and may boost the body's immune response against tumors.\n\nThe study has two phases. The first phase (6 patients) tests the safety of the diet. The second phase (134 patients) randomly assigns participants to receive either the arginine-free diet plus standard chemoradiotherapy or standard chemoradiotherapy alone.\n\nThe arginine-free diet is provided as a liquid nutritional formula for 4 weeks. The main goal is to see if the diet increases the complete response rate (tumor disappearance). We will also evaluate survival outcomes, side effects, and quality of life.",[170],"Rectal Neoplasms","2026-08-05",{"date":110,"type":33},{"date":112,"type":22},{"date":175,"type":22},"2029-06-30",{"name":39,"class":40},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":156},"100636990","phase-2-neoadjuvant-ici-and-mitochondrial-vaccine-for-resectable-hnscc-100636990","NCT07572864","Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC","Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Engineered Mitochondrial Vaccine as Neoadjuvant and Adjuvant Therapy for Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm, Single-Center Clinical Study.","Inclusion Criteria:\n\n1. Aged ≥ 18 years, both genders eligible.\n2. Pathologically confirmed head and neck squamous cell carcinoma (HNSCC) meeting the following criteria:\n\n   1. Clinical stage II-IVB according to the AJCC 8th Edition (nasopharyngeal carcinoma is excluded);\n   2. Positive expression of IMP3 protein;\n   3. Clinically resectable as determined by a Multidisciplinary Team (MDT);\n   4. Subjects must be willing and able to undergo radical surgery.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n4. Adequate organ and bone marrow function, defined as:\n\n   1. Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 80 × 10\\^9\u002FL; Hemoglobin (HGB) ≥ 8 g\u002FdL;\n   2. Liver Function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline phosphatase (ALP) ≤ 2.5 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN;\n   3. Albumin (ALB) ≥ 2.8 g\u002FdL;\n   4. Renal Function: Serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCR) \\> 60 mL\u002Fmin;\n   5. Coagulation: International Normalized Ratio (INR) ≤ 1.5; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n5. Subjects must voluntarily participate in the study, sign the Informed Consent Form (ICF), and be able to comply with the scheduled visits and protocol procedures.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal carcinoma, or other malignancies that the investigator deems eligible.\n2. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (except for Type I diabetes mellitus on a stable dose of insulin).\n3. Contraindications related to subcutaneous injection (specific to vaccination):\n\n   1. Active inflammation, trauma, or skin breakdown at the intended injection site;\n   2. Severe bleeding or coagulation tendency, or significantly reduced platelets\u002Fclotting factors assessed by the investigator as high risk for bleeding;\n   3. Any abnormal or permanent body art (e.g., tattoos) at the intended injection site that, in the investigator's opinion, would interfere with the observation of local skin reactions.\n4. Known allergy to the study drugs or any excipients. History of severe allergies to any drugs, food, or vaccines (e.g., anaphylactic shock, laryngeal edema, dyspnea, Henoch-Schonlein purpura, thrombocytopenic purpura, or Arthus reaction).\n5. Prior receipt of any of the following treatments:\n\n   1. Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4, EGFR antibodies, or EGFR-TKIs;\n   2. Prior vaccination with any anti-tumor vaccines;\n   3. Receipt of any live\u002Factive vaccines against infectious diseases (e.g., influenza, varicella) within 4 weeks prior to the first dose or planned during the study period.\n6. Requirement for systemic steroid therapy (prednisone equivalent dose \\> 10 mg\u002Fday) within 14 days prior to enrollment.\n7. Major surgery or severe trauma within 4 weeks prior to the first dose.\n8. Toxicity from prior anti-tumor therapy not recovered to ≤ CTCAE (Version 5.0) Grade 1 (except for alopecia, or sequelae of neurotoxicity related to prior platinum therapy) or levels specified in the inclusion\u002Fexclusion criteria.\n9. Severe medical conditions, including: Grade II or higher cardiac dysfunction (NYHA criteria); ischemic heart disease (e.g., myocardial infarction or angina); clinically significant supraventricular or ventricular arrhythmias; poorly controlled diabetes (fasting blood glucose ≥ 10 mmol\u002FL); poorly controlled hypertension (SBP \\> 150 mmHg and\u002For DBP \\> 100 mmHg); LVEF \\\u003C 50% on echocardiography; QTc interval \\> 450 msec (males) or \\> 470 msec (females); or other ECG abnormalities deemed by the investigator to pose extra risk.\n10. History of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD; or any condition that might interfere with the detection or management of drug-related pulmonary toxicity (except for asymptomatic drug-induced or radiation-induced pneumonitis); active tuberculosis (TB) or history of uncontrolled TB.\n11. Hyperthyroidism or organic thyroid disease. Hypothyroidism on a stable dose of thyroid replacement therapy or hypothyroidism that can be controlled by replacement therapy (as confirmed by the investigator and\u002For endocrinology) is eligible.\n12. Active infection, unexplained fever occurring within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the Informed Consent Form (ICF).\n13. Active Hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10\\^4 copies\u002FmL), Hepatitis C (HCV antibody positive and HCV RNA above the limit of detection), or known history of HIV infection or AIDS.\n14. History of neurological or psychiatric disorders, such as epilepsy or dementia.\n15. History of drug abuse or alcohol abuse within the past 3 months.\n16. Pregnant or lactating women; subjects (or their partners) planning for pregnancy or engaging in unprotected sexual intercourse from screening until 3 months after the end of the study.\n17. Receipt of any other investigational drug within 4 weeks prior to the first dose, or concurrent enrollment in another clinical study, except for observational (non-interventional) studies or the follow-up phase of an interventional study.\n18. Other factors judged by the investigator that may interfere with the completion of the study treatment or follow-up.",{"count":126,"type":22},[25],"Head and neck squamous cell carcinoma (HNSCC) presents a significant clinical challenge, as over 60% of patients are diagnosed at a locally advanced stage with a high risk of recurrence. Although the landmark KEYNOTE-689 trial established neoadjuvant immune checkpoint inhibitor (ICI) therapy as a new standard of care, the pathological complete response (pCR) rate remains unsatisfactory at only 3.0%, highlighting an urgent need for optimized combination strategies. This prospective, single-arm, single-center clinical study aims to evaluate the safety, tolerability, and preliminary efficacy of a novel neoadjuvant and adjuvant regimen combining an engineered mitochondrial vaccine (IMP3-Mito) with ICIs for patients with resectable, IMP3-positive locally advanced HNSCC. The rationale is based on a \"Prime-and-Release\" synergistic mechanism: the engineered mitochondrial vaccine serves as a potent \"natural adjuvant\" to activate dendritic cells and prime tumor-specific T-cell responses against the IMP3 antigen, while the ICI subsequently releases the immune brakes within the tumor microenvironment. By integrating these two modalities, the study seeks to achieve deeper pathological responses and improve long-term survival, while simultaneously providing clinical evidence for the transformative potential of the mitochondrial engineering platform in overcoming the limitations of conventional tumor vaccines.",[109],{"date":189,"type":33},"2026-08-07",{"date":191,"type":33},"2026-06-29",{"date":193,"type":22},"2028-05-01",{"name":39,"class":40},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":19,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":95},"100650024","phase-2-a-single-arm-study-of-sintilimab-and-disitamab-vedotin-for-locally-advanced-eyelid-sebaceous-gland-carcinoma-100650024","NCT07740993","A Single-Arm Study of Sintilimab and Disitamab Vedotin for Locally Advanced Eyelid Sebaceous Gland Carcinoma","A Single-Arm, Prospective Clinical Study of Sintilimab Combined With Disitamab Vedotin as Neoadjuvant Therapy for Locally Advanced Eyelid Sebaceous Gland Carcinoma","Inclusion Criteria:\n\n1.Age 18 to 85 years (inclusive), regardless of gender; 2.Pathologically confirmed sebaceous gland carcinoma of the eyelid meeting the following criteria: a) Locally advanced disease; b) Deemed resectable or potentially resectable based on ophthalmic evaluation; c) Willing to undergo surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 4. Adequate organ and bone marrow functions defined as follows: a) Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 80 × 10\\^9\u002FL; Hemoglobin ≥ 8 g\u002FdL; b) Hepatic function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; c) Serum albumin ≥ 2.8 g\u002FdL; d) Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR) \\> 60 mL\u002Fmin; e) Coagulation function: International Normalized Ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 5. Volunteer to participate in the study, provide written informed consent, and be capable of complying with all protocol-specified visits and related procedures\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded: 1) History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and gastrointestinal intramucosal carcinoma with no recurrence within 5 years, or other malignancies deemed eligible by the investigator; 2) Any active autoimmune disease or history of autoimmune disease; 3) History of allergic diseases, severe drug allergies, or any component of the prescription (Note: severe allergy refers to those resulting in hospitalization); 4) Received any of the following treatments: a) Prior treatment with anti-PD-1, anti-PD-L1, or anti-HER2 therapies; b) Prior vaccination with anti-tumor vaccines; c) Use of any live vaccines against infectious diseases (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned during the study period; d) Major surgery or severe trauma within 4 weeks prior to the first dose; 5) Concomitant severe medical conditions; 6) Known history of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD, or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity (subjects with a history of drug-induced or radiation-induced asymptomatic non-infectious pneumonitis are allowed to be enrolled), active tuberculosis, or a history of tuberculosis infection that remains uncontrolled after treatment; 7) Patients with hyperthyroidism and patients with organic thyroid diseases cannot be enrolled, patients with hypothyroidism on a stable dose of thyroid hormone replacement therapy can be enrolled, and patients with hypothyroidism controlled by thyroid hormone replacement therapy can be enrolled (whether it is controlled shall be confirmed by the investigator and\u002For the endocrinology department); 8) Active infection, or unexplained fever occurring during screening or within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the informed consent form; 9) Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL) or hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection of the assay), or a known history of positive human immunodeficiency virus (HIV) test, or known acquired immunodeficiency syndrome (AIDS); 10) Clear prior history of neurological or psychiatric disorders, such as epilepsy or dementia; 11) Clear history of drug abuse or history of alcohol abuse within 3 months; 12) Pregnant or lactating women, subjects (and their partners) who have reproductive plans, engage in unprotected sexual intercourse, or are unwilling to adopt appropriate contraceptive methods (such as condoms, intrauterine devices, or partner ligation) from the screening period up to 3 months after the end of the study; 13) Received any investigational drug within 4 weeks prior to the first use of the study drug, or concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up phase of an interventional clinical study; 14) Other factors deemed by the investigator that may affect the study, leading to the inability to complete study treatment and follow-up",{"count":7,"type":22},[25],"The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant therapy with Sintilimab combined with Disitamab Vedotin in patients with locally advanced, resectable or potentially resectable sebaceous gland carcinoma. The main questions it aims to answer are: What is the major pathological response (MPR) rate after the neoadjuvant therapy? What are the pathological complete response (pCR) rate, clinical objective response rate (ORR), disease control rate (DCR), safety profiles, and 1-year disease-free survival (DFS) of this regimen? Participants will:Receive neoadjuvant therapy consisting of Sintilimab (200 mg, IV, Day 1) and Disitamab Vedotin (2.5 mg\u002Fkg, IV, Day 1) every 3 weeks for a total of 2 cycles. Undergo radical surgery after the completion of the neoadjuvant treatment phase. Receive postoperative adjuvant therapy after surgery, which includes uniform Sintilimab monotherapy maintenance (200 mg, IV, Q3W) for up to 1 year, and may receive risk-stratified local interventions (such as local radiotherapy or repeat wide excision) depending on the pathological risk factors.",[206],"Sebaceous Gland Carcinoma","2026-07-31",{"date":209,"type":33},"2026-08-03",{"date":114,"type":22},{"date":212,"type":22},"2028-06-01",{"name":39,"class":40},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":222,"minAge":76,"maxAge":145,"enrollmentInfo":223,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"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.","FEMALE",{"count":224,"type":22},263,"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.",[227],"Breast Reconstruction After Mastectomy",[229,230,231],"delayed Endoscopic DTI","DIEP","TRAM",{"date":233,"type":33},"2026-08-04",{"date":65,"type":22},{"date":236,"type":22},"2030-12-31",{"name":39,"class":40},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100630693","phase-2-disitamab-vedotin-combined-with-sintilimab-and-multimodal-radiotherapy-for-her2-positive-advanced-gastric-cancer-after-second-line-treatment-failure-a-prospective-single-arm-phase-ii-clinical-trial-100630693","NCT07490990","Disitamab Vedotin Combined With Sintilimab and Multimodal Radiotherapy for HER2-Positive Advanced Gastric Cancer After Second-Line Treatment Failure: A Prospective, Single-Arm Phase II Clinical Trial","Inclusion criteria\n\n1. Age: 18-75 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n3. Liver function: Child-Pugh class A.\n4. Histopathologically confirmed advanced gastric cancer with HER2-positive status, defined as HER2 IHC 2+ or 3+, as determined by central laboratory testing.\n5. Failure of or intolerance to standard first-line and second-line treatments.\n6. At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). If a lesion has previously received local therapy, it may be considered measurable only when unequivocal disease progression has been confirmed. In addition, patients should have at least two measurable lesions suitable for radiotherapy, separate from the RECIST target lesions whenever feasible.\n7. Patients with controlled hepatitis B virus (HBV) infection are eligible if they have received anti-HBV therapy for at least 1 month before the first dose of study medication, and have an HBV viral load \\\u003C 2000 IU\u002FmL (10 000 copies\u002FmL) before the first dose. Patients receiving ongoing anti-HBV therapy must maintain the same regimen throughout the study treatment period.\n8. Major organ function must meet the following criteria within 28 days before treatment initiation:\n\n1)Hematological parameters, without blood transfusion within the preceding 14 days: hemoglobin (HB) ≥ 80 g\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 80 × 10⁹\u002FL.\n\n2)Biochemical parameters: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in subjects with liver metastasis; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin.\n\n3)Coagulation parameters: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. For subjects on anticoagulant therapy, PT and APTT within the therapeutic range are acceptable.\n\n4)Thyroid function: Normal T3 and T4 levels. (9)Women of childbearing potential must agree to use effective contraception during the study and for 120 days after the last dose of study treatment. A negative serum or urine pregnancy test is required within 7 days before study enrollment.\n\n(10) Patients must provide written informed consent before enrollment. Exclusion Criteria\n\n1. History of other malignant tumors within the past 5 years or concurrent other malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma.\n2. History of anaphylaxis or severe hypersensitivity to disitamab vedotin, sintilimab, or any excipients of these drugs.\n3. Prior treatment with disitamab vedotin or sintilimab.\n4. Patients with symptomatic central nervous system metastases.\n5. Patients receiving treatment with a strong CYP3A4 inhibitor within 1 week before enrollment, or treatment with a strong CYP3A4 inducer within 2 weeks before enrollment.\n6. Congestive heart failure classified as New York Heart Association (NYHA) functional class III-IV.\n7. History of an ischemic cardiovascular event within 1 year before enrollment.\n8. Ongoing systemic immunosuppressive therapy.\n9. Participation in another interventional clinical trial of investigational medicinal products within 4 weeks before the first dose of study medication.\n10. Requirement for systemic corticosteroids, equivalent to \\> 10 mg prednisone per day, or other immunosuppressive agents within 2 weeks before the first dose of study medication.\n11. Administration of an antitumor vaccine or a live attenuated vaccine within 4 weeks before the first dose of study medication.\n12. Patients with severe infection within 4 weeks before the first dose of study medication.\n13. Active autoimmune disease or history of autoimmune disease and history of immunodeficiency.\n14. Active pulmonary tuberculosis, history of active pulmonary tuberculosis within 1 year before enrollment, or history of active pulmonary tuberculosis more than 1 year before enrollment without standard anti-tuberculosis treatment.\n15. Active viral hepatitis: HBV DNA ≥ 2000 IU\u002FmL (10 000 copies\u002FmL); or hepatitis C virus (HCV) infection, defined as positive anti-HCV antibody and HCV-RNA above the lower limit of detection of the assay.\n16. Known history of psychotropic substance abuse, alcoholism, or illicit drug use.\n17. Pregnancy or breastfeeding women.",{"count":245,"type":22},30,[25],"Patients with HER2-positive advanced gastric cancer who experience disease progression after standard first- and second-line therapies have limited subsequent treatment options. Disitamab vedotin, a novel anti-HER2 antibody-drug conjugate (ADC), has been approved in China for this patient population. Immune checkpoint inhibitors (ICIs) serve as a core therapeutic modality for advanced gastric cancer; however, treatment discontinuation often occurs due to disease progression or immune-related adverse events, which raises clinical demands for immunotherapy rechallenge. Preclinical and early clinical evidence suggests that disitamab vedotin may remodel the tumor immune microenvironment and generate synergistic anti-tumor activity with PD-1 blockade. Furthermore, multimodal radiotherapy combining low-dose radiotherapy (LDRT) and high-dose hypofractionated radiotherapy (HFRT) can enhance systemic anti-tumor immunity through tumor antigen release and remodeling of the tumor immune microenvironment.\n\nThis prospective, multicenter, interventional, single-arm phase II clinical study aims to evaluate the efficacy and safety of disitamab vedotin combined with sintilimab and multimodal radiotherapy in patients with HER2-positive advanced gastric cancer with progression following first- and second-line systemic therapy. Eligible participants will receive protocol-specified disitamab vedotin and sintilimab, followed by multimodal radiotherapy delivered to at least two independent lesions. The primary endpoint is progression-free survival (PFS) assessed according to RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety profile. Exploratory biomarker analyses will be conducted using matched tumor tissue and peripheral blood specimens. A total of 30 participants will be enrolled. This trial is conducted in accordance with the Declaration of Helsinki and relevant Chinese biomedical research regulations. All enrolled patients will provide written informed consent, and the study has obtained ethical approval from the Ethics Committee of West China Hospital, Sichuan University.",[249],"HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","2026-07-30",{"date":209,"type":33},{"date":253,"type":22},"2026-06",{"date":255,"type":22},"2028-12",{"name":39,"class":40},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":278,"locationsCount":4},"100649739","phase-2-iparomlimab-and-tuvonralimab-ql1706-plus-lenvatinib-and-chemotherapy-for-extrapulmonary-neuroendocrine-carcinoma-100649739","NCT07738159","Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma","A Prospective, Randomized, Controlled Clinical Trial of Iparomlimab and Tuvonralimab Injection (QL1706) Plus Lenvatinib and Chemotherapy as First-Line Treatment for Extrapulmonary Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed locally advanced unresectable or metastatic extrapulmonary neuroendocrine carcinoma. Eligible primary sites include the gastrointestinal tract, pancreas, biliary tract, and other extrapulmonary organs. Neuroendocrine carcinoma of the digestive system must be diagnosed according to the 2019 World Health Organization Classification of Tumours of the Digestive System.\n2. Age ≥18 years, with no restriction on sex.\n3. Life expectancy of at least 12 weeks.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n5. Patients must not have received prior first-line systemic anticancer therapy for advanced or metastatic disease. Patients who previously received adjuvant therapy following curative surgery are eligible, provided that disease recurrence occurred more than 6 months after completion of adjuvant therapy.\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n7. No severe complications related to the primary tumor, including perforation, obstruction, or major bleeding that cannot be adequately controlled with medical treatment.\n8. Adequate organ function, as demonstrated by the following laboratory results obtained within 7 days before enrollment. Patients must not have received blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other supportive treatment affecting the relevant laboratory parameters within 14 days before the first dose of study treatment: Hemoglobin ≥90 g\u002FL; Platelet count ≥75 × 10⁹\u002FL; White blood cell count ≥3.0 × 10⁹\u002FL; Absolute neutrophil count ≥1.5 × 10⁹\u002FL; Total bilirubin ≤1.5 × the upper limit of normal (ULN); Serum creatinine ≤1.5 × ULN; Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN, or ≤5 × ULN in participants with liver metastases.\n9. Participants with active hepatitis B virus or hepatitis C virus infection must have received antiviral therapy for at least 14 days before the first dose of study treatment. Hepatitis B virus DNA must be ≤500 IU\u002FmL or ≤2,500 copies\u002FmL, and hepatitis C virus RNA must be below the lower limit of detection of the applicable assay. Such participants must be willing to continue effective antiviral treatment throughout the study.\n10. Voluntary participation in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Histologically confirmed neuroendocrine tumor, mixed adenoneuroendocrine carcinoma, or other non-neuroendocrine carcinoma pathological types.\n2. History of another malignancy with a disease-free interval of less than 5 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or a gastrointestinal tumor confirmed to have been cured by endoscopic mucosal resection.\n3. Uncontrolled hypertension despite medical treatment, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg.\n4. Urine protein ≥2+ on routine urinalysis or 24-hour urinary protein ≥1 g.\n5. Major surgery within 4 weeks before enrollment, excluding diagnostic biopsy, or an incompletely healed surgical wound.\n6. Severe gastrointestinal disorders that may affect drug absorption, including but not limited to peptic ulcer, ulcerative colitis, active gastrointestinal bleeding, gastrointestinal obstruction, or severe diarrhea.\n7. A history of severe bleeding within the previous 3 months, defined as a single bleeding episode of \\>30 mL; hemoptysis within the previous 1 month, defined as a single episode of \\>5 mL; or a thromboembolic event within the previous 12 months, including pulmonary embolism or cerebral infarction.\n8. Severe cardiovascular disease, including but not limited to acute myocardial infarction, unstable angina, heart failure, ventricular arrhythmia requiring medical treatment, left ventricular ejection fraction \\\u003C50%, or New York Heart Association cardiac functional class II or higher.\n9. Corrected QT interval (QTc) \\>480 ms on electrocardiography.\n10. Active autoimmune disease, a history of autoimmune disease with a risk of recurrence, or another condition requiring immunosuppressive treatment, such as prior organ transplantation. Participants with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin disorders not requiring systemic treatment, such as vitiligo, psoriasis, or alopecia, may be enrolled.\n11. A history of interstitial lung disease or noninfectious pneumonitis that is symptomatic, or a previous pulmonary condition that may interfere with the evaluation or management of study treatment-related pulmonary toxicity.\n12. Active pulmonary tuberculosis within 1 year before the first dose of study treatment. Patients with a history of active pulmonary tuberculosis more than 1 year before the first dose must undergo careful evaluation, including sputum smear examination, T-SPOT.TB testing, erythrocyte sedimentation rate testing, and chest computed tomography. Such participants may be enrolled only if there is no evidence of active pulmonary tuberculosis.\n13. A history of chronic persistent diarrhea or the presence of complete intestinal obstruction.\n14. Requirement for systemic treatment with corticosteroids at a prednisone-equivalent dose of \\>10 mg\u002Fday or other immunosuppressive agents within 14 days before the first dose of study treatment. Inhaled or topical corticosteroids and adrenal replacement therapy at a prednisone-equivalent dose of ≤10 mg\u002Fday are permitted in the absence of active autoimmune disease. Short-term corticosteroid use for ≤7 days is permitted for prophylaxis, such as prevention of contrast-media allergy, or for the treatment of non-autoimmune conditions, such as delayed hypersensitivity caused by contact allergens.\n15. Prior treatment with any antibody or drug targeting a T-cell co-regulatory protein or immune checkpoint, including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 therapies.\n16. Immunodeficiency disorder or human immunodeficiency virus infection.\n17. Severe medical or surgical comorbidities that impair organ function, or an acute infection associated with a body temperature \\>38°C, which, in the investigator's judgment, would make the patient unsuitable for the study.\n18. Leptomeningeal metastases or symptomatic brain metastases.\n19. Pregnant or breastfeeding women, or patients of reproductive potential, including male patients and women who have been postmenopausal for less than 1 year, who are unwilling to use effective contraception.\n20. A history of allergy or hypersensitivity to any component of the study treatments.\n21. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.",{"count":265,"type":22},92,[25],"The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.",[269,270,271,272],"Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)","QL1706","Lenvatinib","Chemotherapy","2026-07-28",{"date":207,"type":33},{"date":114,"type":22},{"date":277,"type":22},"2030-09-01",{"name":39,"class":40},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":95},"100624451","phase-1-ymn-136-vaccine-for-patients-with-liver-metastasis-of-colorectal-cancer-progressing-after-third-line-treatment-100624451","NCT07409805","YMN-136 Vaccine for Patients With Liver Metastasis of Colorectal Cancer Progressing After Third-Line Treatment","Evaluation of Safety and Efficacy of YMN-136 Vaccine in Patients With Liver Metastasis of Colorectal Cancer Progressing After Third-Line Treatment: A Prospective Phase I Clinical Study","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, be able to understand and agree to follow the prescribed research procedures and visits;\n2. Aged 18-75 years, both male and female are eligible;\n3. Histologically confirmed unresectable advanced colorectal adenocarcinoma;\n4. Patients with colorectal cancer liver metastasis who have failed third-line treatment, defined as those who have experienced disease progression (based on RECIST 1.1 criteria) or terminated treatment due to intolerance to toxicity after completing at least three different treatment regimens in the standard sequence during systemic treatment for colorectal cancer. The specific treatment pathway usually includes:\n\n   * First-line treatment: Chemotherapy combined with targeted drugs (such as FOLFOX\u002FFOLFIRI combined with anti-EGFR cetuximab or anti-VEGF bevacizumab).\n   * Second-line treatment: Switch to a different chemotherapy regimen (e.g., FOLFIRI for second-line treatment if FOLFOX was used for first-line treatment) and replace the targeted drug (e.g., alternating between anti-EGFR and anti-VEGF drugs).\n   * Third-line treatment: Standard third-line drugs include Regorafenib, TAS-102, or Furadixone, or novel drugs participating in clinical trials.\n5. Eastern Cooperative Oncology Group (ECOG) physical status score: 0 or 1;\n6. Expected survival ≥12 weeks;\n7. During the screening period, the organ function levels must meet the following requirements:\n\n   * Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   * Platelet count (PLT) ≥100×10\\^9\u002FL;\n   * Hemoglobin (Hb) ≥90g\u002FL;\n   * Total bilirubin (TBIL) ≤1.5×ULN;\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, and ≤5×ULN for patients with liver metastasis;\n   * Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate (Cockcroft-Gault formula) ≥45 mL\u002Fmin;\n   * International normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;\n   * QTc interval calculated according to Fridericia criteria, ≤450ms for males and ≤470ms for females; • Urine routine test\u002F24-hour urine protein quantitation: urine protein qualitative test ≤1+ (if urine protein qualitative test ≥2+, then 24-hour urine protein \\\u003C1g is acceptable for enrollment);\n   * Cardiac function: left ventricular ejection fraction ≥50%\n8. Qualified patients (males or females) with reproductive capacity must agree to use a medically approved physical contraceptive method (such as intrauterine device, condom, tubal or vasectomy ligation, etc.) during the trial period and within 6 months after the last dose; female patients of childbearing age must have negative serum or urine HCG test results during the screening period.\n\nExclusion Criteria:\n\n1. Patients with extensive peritoneal metastasis or intestinal obstruction; patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n2. Patients known to be allergic to the components of the investigational drug (such as lipid nanoparticles, RNA vectors) or similar drugs;\n3. Patients who have previously received vaccine therapy;\n4. Patients who have received chemotherapy, targeted therapy, or immunotherapy within 4 weeks before the first dose;\n5. During the dose escalation and dose expansion phases: Patients who have received anti-tumor treatment, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, biotherapy, or treatment with drugs from other clinical trials, within 4 weeks or 5 drug half-lives (whichever is shorter, but at least 14 days) before the first dose; Patients who have taken traditional Chinese medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 14 days before the first dose;\n6. Patients who are expected to use immunosuppressive drugs during the study period within 4 weeks before the first dose, except for corticosteroid nasal sprays, inhalants, or systemic prednisone ≤10 mg\u002Fday and equivalent treatments;\n7. Patients with a history of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation;\n8. Patients who have received attenuated live vaccines within 28 days before the first dose;\n9. During the dose escalation and dose expansion phases: Patients with symptomatic, untreated, or requiring continuous treatment (including corticosteroids and antiepileptic drugs) for central nervous system (CNS) metastasis (previously treated patients who have had stable clinical symptoms for at least 4 weeks before enrollment, have excluded evidence of new or expanding metastasis, and have discontinued steroid treatment may be enrolled; patients with asymptomatic brain metastasis and no need for treatment may be enrolled);\n10. During the dose escalation and dose expansion phases: Patients who have not recovered to baseline or grade 0-1 (excluding alopecia and pigmentation) as defined by NCI CTCAE v5.0 after previous anti-tumor treatment. Patients with reasonably expected irreversible toxicity that will not be exacerbated by the study drug may be enrolled after confirmation with the investigator;\n11. Patients with a history of autoimmune diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, etc. Type 1 diabetes, hypothyroidism that can be controlled only by replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo and psoriasis) can be included in the trial;\n12. history of immediate hypersensitivity reactions, eczema or asthma that cannot be controlled by topical corticosteroids;\n13. history of other malignant tumors, except for curable tumors that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or cervical carcinoma in situ, and breast carcinoma in situ.\n14. Concurrent uncontrollable concomitant diseases, including but not limited to: unexplained fever \\> 38.5°C (subjects with tumor-related fever to be determined by the investigator for inclusion in the study), symptomatic congestive heart failure with New York Heart Association (NYHA) functional class ≥2, left ventricular ejection fraction (LVEF) \\\u003C50%, poorly controlled hypertension (systolic blood pressure \\>160mmHg and\u002For diastolic blood pressure \\>100mmHg after treatment, and clinically significant as assessed by the investigator), unstable angina or acute myocardial infarction within 3 months prior to the first dose, poorly controlled arrhythmia; patients with chronic obstructive pulmonary disease, asthma, interstitial lung disease, and decreased lung function;\n15. patients with active infection who currently require systemic anti-infective treatment; patients with active tuberculosis;\n16. known human immunodeficiency virus (HIV)-positive individuals, individuals with active syphilis spirochete infection; individuals who are HBsAg and\u002For HBcAb positive and HBV-DNA \\>500 IU\u002FL; individuals who are HCV-RNA positive;\n17. patients with an expected survival of \\\u003C3 months (based on clinical assessment or Child-Pugh C liver function).",{"count":126,"type":22},[80],"This study aims to determine the safety and maximum tolerated dose (MTD) of YMN-136 vaccine through a dose escalation trial, and to investigate whether YMN-136 vaccine can assist in the treatment of patients with metastatic colorectal cancer.",[290],"Colorectal Cancer",{"date":292,"type":33},"2026-07-29",{"date":294,"type":33},"2026-05-06",{"date":296,"type":22},"2029-06-01",{"name":39,"class":40},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":19,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":314,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":318,"leadSponsor":320,"locationsCount":95},"100649401","rehabilitation-with-wearable-monitors-for-post-lung-cancer-surgery-100649401","NCT07733492","Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery","A Clinical Trial of Postoperative Rehabilitation for Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices","WEAR-LUNG","Inclusion Criteria:\n\n* Age ≥18 and ≤85 years\n* Histopathologically confirmed primary non-small cell lung cancer (NSCLC) who have undergone elective curative-intent lobectomy or segmentectomy\n* Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based rehabilitation\n* Able to operate a smartphone application and wearable devices independently or with caregiver assistance\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Pre-existing long-term home oxygen therapy, or severe resting respiratory dysfunction\n* Concurrent severe, uncontrolled cardiovascular disease, severe hepatic insufficiency, or severe renal insufficiency\n* Other diseases or conditions that significantly affect motor function or compliance\n* Known or suspected contact allergy to medical adhesives or materials used in the wearable devices\n* Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation",{"count":307,"type":22},126,[106],"This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for non-small cell lung cancer (NSCLC).\n\nEligible participants will be randomized to either the intervention group or the control group. Both groups receive standard postoperative rehabilitation education. The intervention group additionally receives a wearable device (chest patch or wristband) for continuous monitoring of SpO₂, heart rate, respiratory rate, and physical activity, along with a smartphone-based digital rehabilitation program including individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training), daily symptom diaries, and remote feedback with threshold-triggered alerts for up to 90 days after discharge. The control group receives standard rehabilitation education with routine follow-up.\n\nThe primary endpoint is the between-group difference in FEV1% predicted at postoperative day 90, analyzed using ANCOVA adjusted for baseline FEV1% predicted. Secondary endpoints include FVC% predicted, 6-minute walk distance, daily step count, SpO₂ \\\u003C90% time burden, quality of life (EORTC QLQ-C30\u002FLC13, mMRC), 90-day readmission and emergency visit rates, and safety outcomes.\n\nA total of 126 participants (63 per group) will be enrolled. The study is being conducted at West China Hospital of Sichuan University from June 2026 to October 2027.",[311,312,313],"Non-Small Cell Lung Cancer (NSCLC)","Rehabilitation","Thoracic Surgery",[311,312,313],"2026-07-24",{"date":292,"type":33},{"date":35,"type":22},{"date":319,"type":22},"2028-08-31",{"name":39,"class":40},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":222,"minAge":76,"maxAge":50,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":342,"locationsCount":4},"100648483","phase-1-a-single-arm-open-label-prospective-study-evaluating-the-safety-tolerability-and-immunogenicity-of-the-neoovsv-vaccine-in-patients-with-ovarian-cancer-after-surgery-100648483","NCT07724106","A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVSV Vaccine in Patients With Ovarian Cancer After Surgery","NeoOVSV","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.",{"count":126,"type":22},[80],"This is a Phase I, single-arm, open-label, prospective, non-randomized, single-center dose-escalation study. The study will evaluate the safety, tolerability, and preliminary activity of the NeoOVSV mRNA-lipid nanoparticle vaccine in patients with stage II\u002FIII ovarian cancer after surgery, in combination with standard adjuvant chemotherapy and a PD-1 antibody.",[332,333],"Ovarian Cancer","mRNA Vaccine",[335,336],"ovarian cancer","mRNA vaccine","2026-07-20",{"date":339,"type":33},"2026-07-23",{"date":207,"type":22},{"date":193,"type":22},{"name":39,"class":40},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":164,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":4},"100648115","remote-versus-on-site-robotic-surgery-for-hepatobiliary-and-pancreatic-procedures-100648115","NCT07716423","Remote Versus On-Site Robotic Surgery for Hepatobiliary and Pancreatic Procedures","Safety and Efficacy of Remote Versus On-Site Robotic Surgery in Hepatobiliary and Pancreatic Procedures: An International, Multicenter, Prospective, Randomized, Single-Blind, Non-Inferiority Controlled Trial","Inclusion Criteria:\n\n* Age 18 to 80 years, regardless of sex.\n* Scheduled to undergo robot-assisted hepatobiliary or pancreatic surgery, limited to hemihepatectomy, liver segmentectomy, local liver resection, cholecystectomy, pancreaticoduodenectomy, or distal pancreatectomy.\n* Considered to have an indication for surgery and to be suitable for robotic surgery based on preoperative assessment.\n* No definite contraindication to robotic surgery, laparoscopic surgery, pneumoperitoneum, or general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status class I to III.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n* Expected survival of at least 3 months.\n* Adequate major organ function, with laboratory test results within 7 days before enrollment meeting the following criteria: white blood cell count at least 2.5 x 10\\^9\u002FL, absolute neutrophil count at least 1.5 x 10\\^9\u002FL, platelet count at least 75 x 10\\^9\u002FL, hemoglobin at least 90 g\u002FL, international normalized ratio no more than 1.5 x upper limit of normal, and serum creatinine no more than 1.5 x upper limit of normal.\n* For patients undergoing liver surgery, Child-Pugh class A liver function or Child-Pugh class B liver function considered tolerable for surgery, with adequate liver reserve and adequate predicted future liver remnant volume.\n* For patients undergoing pancreatic surgery, imaging assessment showing resectability by robotic surgery without the need for complex vascular reconstruction.\n* Willing and able to complete perioperative observation and postoperative follow-up according to the study protocol.\n* Voluntarily agrees to participate in the study and provides written informed consent.\n\nExclusion Criteria:\n\n* Need for combined vascular reconstruction.\n* Need for two or more major hepatobiliary or pancreatic procedures at the same time, or need for major resection of other organs.\n* Unable to complete full preoperative assessment, randomization, or remote robotic system preparation.\n* Considered clearly unsuitable for robotic surgery before the operation.\n* Preoperative assessment indicating a high probability of conversion to open surgery, or difficulty safely completing the planned procedure using a robotic platform.\n* Uncorrectable severe coagulation disorder or active bleeding tendency.\n* Severe dysfunction of the heart, lung, liver, kidney, brain, or other major organs that makes the patient unable to tolerate general anesthesia, pneumoperitoneum, or the planned surgery.\n* For patients undergoing liver surgery, inadequate liver reserve or inadequate predicted future liver remnant volume for safe surgery.\n* Uncontrolled severe infection, sepsis, severe malnutrition, or other conditions that significantly increase perioperative risk.\n* Pregnant or breastfeeding women.\n* Severe psychiatric, cognitive, or communication disorder that prevents cooperation with the study or follow-up.\n* Major compliance concerns as judged by the investigator.\n* Currently participating in another interventional clinical study that may affect endpoint assessment in this study.\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.",{"count":351,"type":22},168,[106],"This study will compare remote robotic surgery with on-site robotic surgery for patients who need surgery for diseases of the liver, bile duct, gallbladder, or pancreas. Remote robotic surgery means that an experienced surgeon controls the robotic surgical system from a different location, while the patient and the operating room team are at the local hospital. On-site robotic surgery means that the surgeon controls the robotic system in the same hospital as the patient.\n\nThe main purpose of this study is to find out whether remote robotic surgery is not worse than on-site robotic surgery in terms of surgical success. Surgical success means that the planned robotic operation is completed safely, without unplanned conversion to open surgery or standard laparoscopic surgery, without major unexpected injury, and without serious problems related to the remote robotic system, network, or communication.\n\nEligible patients will be adults who are scheduled to undergo selected robotic hepatobiliary or pancreatic procedures, including hepatectomy, liver segmentectomy, local liver resection, cholecystectomy, pancreaticoduodenectomy, or distal pancreatectomy. Participants will be randomly assigned to either the remote robotic surgery group or the on-site robotic surgery group. The study is single-blind, which means that participants will not know which group they are assigned to, although the surgical and operating room teams will know because of the nature of the procedure.\n\nThe study will evaluate surgical success, operation time, blood loss, conversion to open surgery, complications, recovery after surgery, length of hospital stay, readmission, reoperation or other interventions, death within 30 and 90 days after surgery, and quality of recovery. For patients in the remote robotic surgery group, the study will also record the performance of the remote surgical system, including network delay, system stability, image transmission, system interruption, and the need for local surgical takeover.\n\nA total of 168 patients are planned to be enrolled. Patients will be followed during hospitalization and after surgery to assess safety, recovery, and short-term clinical outcomes. The results of this study may help determine whether remote robotic surgery can be safely and effectively used for hepatobiliary and pancreatic surgery, especially in hospitals or regions where access to experienced surgical specialists is limited.",[355],"Hepatobiliary and Pancreatic Diseases",[357,358,359,360,361],"Remote Robotic Surgery","Telerobotic Surgery","On-Site Robotic Surgery","Hepatobiliary Surgery","Pancreatic Surgery","2026-07-19",{"date":364,"type":33},"2026-07-21",{"date":366,"type":22},"2026-06-30",{"date":368,"type":22},"2030-06-30",{"name":39,"class":40},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":377,"maxAge":378,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":392,"locationsCount":95},"100577443","phase-2-efficacy-and-safety-of-different-initial-doses-of-oral-propranolol-in-the-treatment-of-ulcerated-infantile-hemangioma-100577443","NCT06798363","Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma","Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma： a Prospective Study","Inclusion Criteria:\n\n1. all patients with ulcer IH;\n2. children with ulcer IH treated with propranolol.\n\nExclusion Criteria:\n\n1\\) children with ulcer IH who received other therapeutic interventions were excluded; 2) Children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons.\n\n\\-","1 Month","4 Years",{"count":380,"type":22},24,[25,382],"PHASE3","The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).",[385],"Infantile Hemangioma",[387],"Infantile hemangioma, ulcer, propranolol",{"date":364,"type":33},{"date":390,"type":33},"2025-05-02",{"date":114,"type":22},{"name":39,"class":40},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":401,"maxAge":164,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":4},"100647814","phase-2-vericiguat-for-the-inhibition-of-calcific-aortic-valve-stenosis-progression-100647814","NCT07715279","Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression","Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (VERIFICATION Study)","VERIFICATION","Inclusion Criteria:\n\n1. The participant agrees to enter this clinical trial and consents to long-term follow-up;\n2. 35 ≤ age \\\u003C 80 years;\n3. Echocardiographically confirmed mild-to-moderate (peak aortic jet velocity ≥ 2.5 m\u002Fs and \\\u003C 4.0 m\u002Fs, aortic valve area \\> 1.0 cm², and mean aortic valve pressure gradient \\\u003C 40 mmHg) non-rheumatic aortic valve stenosis;\n4. Baseline aortic valve calcium score (Agatston score) ≥ 200 AU as measured by cardiac CT;\n5. Male participants, or female participants who are not of childbearing potential, or female participants who commit to avoiding pregnancy through 4 weeks after the end of the trial.\n\nExclusion Criteria:\n\n1. Severe aortic stenosis (AS peak velocity ≥ 4.0 m\u002Fs, or mean transvalvular aortic pressure gradient ≥ 40 mmHg, or aortic valve area ≤ 1.0 cm², or indexed effective aortic valve area \\\u003C 0.6 cm²\u002Fm²), or very mild stenosis (AS peak velocity \\\u003C 2.5 m\u002Fs), or a planned aortic valvuloplasty\u002Freplacement procedure;\n2. Concomitant severe mitral or tricuspid valve disease (moderate or greater mitral or tricuspid regurgitation, or prior mitral or tricuspid valve repair\u002Fvalvuloplasty\u002Freplacement);\n3. Concomitant moderate or greater aortic regurgitation;\n4. Use, within 1 month prior to the screening visit, of medications affecting the NO-sGC-cGMP pathway (e.g., sildenafil, nitrates, etc.), or known hypersensitivity to vericiguat or its components;\n5. Left ventricular ejection fraction (LVEF) \\\u003C 50%, or NYHA class III-IV (see Appendix 4 for NYHA classification criteria);\n6. Presence of a malignancy (except those with an expected cure) or other serious non-cardiac disease with a life expectancy of less than 3 years;\n7. Rheumatic valvular heart disease;\n8. Systolic blood pressure (SBP) \\\u003C 120 mmHg, or a history of symptomatic hypotension, or a history of hemodynamic instability or hypovolemia within the 4 weeks prior to screening;\n9. Presence of hypertrophic obstructive cardiomyopathy (outflow tract obstruction defined as a peak left ventricular outflow tract pressure gradient ≥ 30 mmHg at rest or after provocative testing);\n10. Infective endocarditis or complex congenital heart disease;\n11. Estimated glomerular filtration rate \\\u003C 15 mL\u002Fmin\u002F1.73 m², or on dialysis;\n12. Severe pulmonary disease requiring continuous home oxygen therapy;\n13. Interstitial lung disease;\n14. Concomitant disorder of calcium-phosphate metabolism;\n15. Current use of warfarin;\n16. ALT and AST ≥ 3 times the upper limit of normal, or severe hepatic insufficiency (e.g., cirrhosis, chronic active liver disease);\n17. Inability to undergo contrast-enhanced CT, or contrast media allergy;\n18. Concomitant acute myocarditis, cardiac amyloidosis, cardiac sarcoidosis, or stress (takotsubo) cardiomyopathy;\n19. Presence of acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction) within 60 days prior to randomization, or an indication for coronary revascularization (percutaneous intervention\u002Fbypass surgery); or a need for coronary revascularization identified at the time of randomization;\n20. History of cerebrovascular accident (including TIA or stroke) within 60 days prior to randomization;\n21. Psychiatric disorder or legal incapacity precluding the ability to provide informed consent;\n22. Any medical condition, circumstance, or history that, in the investigator's judgment, would compromise the participant's ability to participate in or complete the study.","35 Years",{"count":403,"type":22},238,[25],"Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body. No drug therapy has been proven to slow CAVS progression. Individuals with mild-to-moderate CAVS are managed with periodic monitoring until the stenosis becomes severe, at which point surgical or transcatheter valve replacement is the only treatment option. The goal of this clinical trial is to determine whether vericiguat, an oral soluble guanylate cyclase (sGC) stimulator, can slow the progression of mild-to-moderate CAVS.\n\nThe primary questions this study aims to answer are:\n\nDoes vericiguat slow the progression of aortic valve calcium accumulation, as measured by the change in aortic valve calcium score from baseline to 24 months, compared to placebo?\n\nThe study will compare vericiguat against a placebo (an inactive pill that is identical in appearance but contains no active drug). Both participants and the research team will not know which treatment each participant is receiving throughout the study.\n\nParticipants will:\n\nTake vericiguat or placebo orally once daily for 24 months; Begin treatment at 2.5 mg\u002Fday and undergo a stepwise dose increase every two weeks to a target dose of 10 mg\u002Fday, provided the drug is tolerated; Attend approximately 8 scheduled study visits over two years, during which they will undergo cardiac imaging examinations (transthoracic echocardiography and non-contrast cardiac CT), blood sample collection, physical assessment, and completion of standardized questionnaires on quality of life and heart failure symptoms; Undergo cardiac magnetic resonance imaging (MRI) at the beginning and end of the study, if there are no contraindications.\n\nApproximately 238 participants will be enrolled across roughly 19 hospitals in China.",[407,408,409],"Calcific Aortic Valve Disease","AORTIC VALVE DISEASES","Aortic Valve Stenosis",[411,412,413,414,415,416],"Vericiguat","BAY1021189","Soluble Guanylyl Cyclase","sGC stimulator","sGC activator","Cyclic GMP","2026-07-18",{"date":364,"type":33},{"date":32,"type":22},{"date":421,"type":22},"2029-11-30",{"name":39,"class":40},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":440,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":452,"locationsCount":453},"100647990","phase-2-pre-hepatectomy-rehabilitation-in-obese-masld-complicated-living-liver-donors-with-mazdutide-prime-100647990","NCT07718126","Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)","Short-term Mazdutide Plus Lifestyle Intervention Versus Placebo for Pre-hepatectomy Prehabilitation in Living Liver Donors With MASLD: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial","PRIME","Inclusion Criteria:\n\n* Age between 18 and 60 years old at the time of signing the informed consent form.\n* Overweight, defined as Body Mass Index (BMI) ≥ 24 kg\u002Fm².\n* Diagnosed with MASLD by non-invasive means (conventional ultrasound, FibroScan®, or MRI), with a Controlled Attenuation Parameter (CAP) ≥ 268 dB\u002Fm via FibroScan®.\n* Histologically confirmed MASLD without any liver fibrosis, presenting a NAS ≥ 3, including a steatosis subscore ≥ 2 (subscores for hepatocyte ballooning and lobular inflammation are not limited).\n* Meets ethical and legal regulations, voluntarily donates a portion of the liver, and the corresponding potential liver transplant recipient must be a spouse or a direct or collateral blood relative within three generations.\n* Understands all procedures and follow-up requirements of the study, participates voluntarily, and signs the written informed consent form in person.\n\nExclusion Criteria:\n\n* Liver biopsy indicates complication with any degree of liver fibrosis.\n* Failure to diagnose overweight or MASLD by non-invasive means, including BMI \\\u003C 24 kg\u002Fm² and\u002For CAP \\\u003C 268 dB\u002Fm.\n* Histological evaluation shows a total NAS \\\u003C 3 and\u002For a steatosis subscore \\\u003C 2.\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN) at screening, and\u002For ALT or AST levels increase by more than 1 fold compared to baseline during screening, which is considered clinically significant by the investigator.\n* Total bilirubin (TBil) \\> 25.6 μmol\u002FL (1.5 mg\u002FdL), and\u002For alkaline phosphatase (ALP) \\> 2 × ULN, and\u002For International Normalized Ratio (INR) \\> 1.35 at screening.\n* Platelet count \\\u003C 150,000\u002FμL at screening, unless considered by the investigator to reflect the patient's daily baseline level and portal hypertension is absent.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m² based on the CKD-EPI formula at screening.\n* Glycated hemoglobin (HbA1c) \\> 9.5% at screening.\n* Unstable weight, defined as self-reported weight change \\> 5% within 90 days prior to screening up to the time of screening.\n* Presence of other clearly defined etiologies causing chronic liver disease (non-NAFLD), including positive HBsAg, positive anti-HIV, or positive HCV RNA at screening, or a known history of HCV RNA or HBsAg positivity within 2 years prior to screening.\n* Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatocellular carcinoma, or liver transplantation at screening and randomization.\n* Presence or history of malignant tumors within 5 years (except basal cell carcinoma, squamous cell skin cancer, and any carcinoma in situ).\n* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).\n* History of acute pancreatitis within 180 days prior to screening, or a history of chronic pancreatitis.\n* Presence or history of gastroparesis, severe gastroesophageal reflux disease, or prior bariatric surgery at screening and randomization.\n* History or presence of type 1 diabetes.\n* Occurrence of myocardial infarction, stroke, NYHA class IV heart failure, hospitalization due to unstable angina, or transient ischemic attack within 90 days prior to screening or during the screening-to-randomization window.\n* Type 2 diabetes accompanied by uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* History of severe depression, suicidal ideation, or recent suicide attempts.\n* Known or suspected allergy to the active ingredients or any excipients of the study drug.\n* Females who are pregnant, lactating, planning a pregnancy, or of childbearing potential but not utilizing highly effective contraceptive methods.\n* Participation in any approved or unapproved investigational drug clinical trial within 180 days prior to screening (defined as exposure to the investigational drug and inclusive of any post-treatment follow-up period).\n* Prior participation in this trial (defined as having already undergone randomization).\n* Known or suspected excessive alcohol consumption (females \\> 20g\u002Fday, males \\> 30g\u002Fday) or presence of alcohol dependence.\n* Use of any GLP-1 receptor agonist (GLP-1RA) within 90 days prior to screening.\n* Receipt of glucose-lowering drugs (except GLP-1RA), lipid-lowering drugs, or weight-loss drugs considered by the investigator to be at unstable doses within 90 days prior to screening.\n* Any condition considered by the investigator to render the participant unsuitable for liver donation, or diseases\u002Fconditions that may compromise participant safety, pose safety hazards from substantial weight loss, or affect compliance with the protocol.\n* The recipient designated to receive the liver graft is not a spouse or a direct or collateral blood relative within three generations, or the donation violates ethical, moral, legal, or regulatory codes.","60 Years",{"count":433,"type":22},60,[25,382],"The purpose of this study is to evaluate the efficacy and safety of a short-term (12-week) prehabilitation strategy combining mazdutide (a novel GLP-1\u002FGCG receptor dual agonist) with lifestyle optimization, compared to lifestyle optimization alone, in potential living liver transplantation donors with metabolic dysfunction-associated steatohepatitis (MASLD).\n\nOverweight or obese individuals who intend to donate a portion of their liver but are temporarily disqualified due to hepatic steatosis will be recruited across multiple clinical centers. Participants will be randomly assigned in a 1:1 ratio to either the experimental group (mazdutide subcutaneous injection once weekly plus standardized lifestyle counseling) or the control group (placebo subcutaneous injection once weekly plus standardized lifestyle counseling).\n\nThe primary objective is to determine whether the short-term addition of mazdutide can significantly increase the proportion of donors achieving histological resolution of hepatic steatosis without the worsening of fibrosis within 12 weeks. The study ultimately aims to provide high-quality evidence for a rapid, safe, and effective surgical prehabilitation protocol to expand the living donor pool and optimize perioperative outcomes for both donors and recipients.",[437,438,439],"Metabolic Dysfunction-Associated Steatohepatitis","Hepatic Steatosis","Living Liver Donors",[441,442,443,444,445,446,447],"Mazdutide","GLP-1\u002FGCG receptor dual agonist","Living Donor Liver Transplantation","Prehabilitation","MASLD","Organ Donation","Preoperative Weight Loss","2026-07-16",{"date":364,"type":33},{"date":65,"type":22},{"date":319,"type":22},{"name":39,"class":40},3,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":468,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":95},"100647941","phase-2-ipilimumab-n01-plus-sintilimab-and-lenvatinib-as-first-line-therapy-for-locally-advanced-or-metastatic-tfe3-rearranged-renal-cell-carcinoma-a-prospective-multicenter-single-arm-phase-ii-clinical-trial-100647941","NCT07715565","Ipilimumab N01 Plus Sintilimab and Lenvatinib as First-line Therapy for Locally Advanced or Metastatic TFE3-Rearranged Renal Cell Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Age ≥14 years, any gender.\n2. Histologically confirmed locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC) by FISH and\u002For next-generation sequencing.\n3. Stage IV disease per the 2017 8th edition TNM staging system.\n4. No prior systemic therapy with immune checkpoint inhibitors (PD-1\u002FPD-L1 inhibitors) or targeted agents (TKI, mTORi); prior targeted therapy ≤1 month is allowed after an adequate washout (5.5 half-lives).\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. Life expectancy ≥3 months.\n7. Signed informed consent and ability to comply with study visits and procedures.\n8. Willingness to provide tumor tissue and blood specimens for correlative studies.\n9. Adequate organ and bone marrow function within 14 days prior to enrollment:\n\nHematology: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL. Hepatic: TBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN, albumin ≥20 g\u002FL. Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Active central nervous system metastases.\n2. History of other malignancies within 3 years (different primary site or histology), except well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.\n3. Major surgery or severe trauma within 4 weeks prior to enrollment.\n4. Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive agents within 14 days before first dose (topical, ophthalmic, intra-articular, intranasal, inhaled, or physiologic replacement steroids are permitted).\n5. Known or suspected active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis), except type 1 diabetes, hypothyroidism requiring hormone replacement only, or skin conditions not requiring systemic treatment. Known allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.\n6. Known hypersensitivity to ipilimumab N01, sintilimab, or lenvatinib.\n7. Uncontrolled severe comorbidities including:\n\n   Active or poorly controlled severe infection. HIV infection. Active hepatitis B (HBsAg-positive and HBV DNA \\>1×10³ IU\u002FmL) or active hepatitis C (HCV antibody-positive and HCV RNA \\>15 IU\u002FmL).\n\n   Active pulmonary tuberculosis. New York Heart Association Class III-IV congestive heart failure, symptomatic arrhythmia, uncontrolled atrial fibrillation, or left ventricular ejection fraction below the lower limit of normal.\n\n   Uncontrolled arterial hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg). Arterial thrombosis, embolism, or ischemia within 6 months (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack).\n\n   Uncontrolled adrenal insufficiency. Severe, non-healing wounds or ulcers; gastrointestinal disorders impairing absorption; active uncontrolled bleeding or high bleeding risk (e.g., esophageal\u002Fgastric varices requiring intervention); or unstable anticoagulation with clinically significant bleeding.\n8. Any other acute or chronic medical or psychiatric condition, or laboratory abnormality, that in the opinion of the investigator increases the risk associated with study participation, may interfere with interpretation of study results, or makes the patient unsuitable for the study.\n9. Pregnant or lactating women.",{"count":461,"type":22},66,[25],"This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Eligible patients (age ≥14 years, ECOG ≤2, measurable disease per RECIST v1.1, no prior systemic therapy) will receive ipilimumab N01 1 mg\u002Fkg Q6W for 4 cycles, sintilimab 200 mg Q3W for up to 35 cycles, and lenvatinib 12 mg or 8 mg QD continuously. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety per NCI CTCAE v5.0, and quality of life. Exploratory biomarker analyses will assess potential predictors of treatment response.",[465,466,467],"Renal Cell Carcinoma (Kidney Cancer)","Immunotherapy","Molecular Targeted Therapy",[469,470,471],"Sintilimab","ipilimumab","lenvatinib","2026-07-15",{"date":337,"type":33},{"date":475,"type":22},"2026-08",{"date":477,"type":22},"2029-12",{"name":39,"class":40},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":164,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":95},"100623594","phase-2-h101-plus-tace-for-rm-hnscc-100623594","NCT07398664","H101 Plus TACE for r\u002Fm HNSCC","Recombinant Human Adenovirus 5 (H101) Combined With Transcatheter Arterial Chemoembolization (TACE) for the Treatment of Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma: A Single-Center, Prospective Study","Inclusion Criteria:\n\n1. Age between 18 and under 80 years old.\n2. Pathologically confirmed head and neck malignancies (including nasopharyngeal carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, salivary gland cancer, nasal cavity and paranasal sinus cancer, etc.); patients who have failed at least two lines of standard treatment (including cetuximab and immuno check point inhibitors).\n3. Expected survival ≥3 months.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.\n5. Pre-treatment peripheral blood tests meet the following conditions: neutrophil count \\>2000\u002Fmm³, platelet count \\>100,000\u002Fmm³.\n6. Pre-treatment liver and kidney function meet the following: bilirubin \\\u003C1.5 mg\u002FdL, AST or ALT \\\u003C1.5 times the upper limit of normal, serum creatinine \\\u003C1.5 mg\u002FdL, creatinine clearance \\>60 mL\u002Fmin.\n7. Agreement to follow the trial treatment plan and visit schedule, voluntary participation, and written informed consent.\n\nExclusion Criteria:\n\n1. Expected survival less than 3 months.\n2. Positive pregnancy test for women of childbearing age.\n3. Concurrent diseases or conditions that affect the patient's ability to enroll normally or safety during the study period.\n4. Active psychiatric disorders or other psychological conditions that affect the patient's ability to sign the informed consent or understand the study.\n5. Severe coagulation abnormalities and\u002For active infection requiring intravenous anti-infective therapy.\n6. History of another malignancy within 5 years prior to screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or microscopic papillary thyroid carcinoma that have been treated with potential curative therapy.\n7. Severe cardiac arrhythmia or conduction abnormalities, and clinically uncontrolled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n8. Adverse reactions from prior anti-tumor treatments have not recovered to CTCAE version 5.0 Grade \\\u003C1 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, Grade 2 peripheral neuropathy, etc.).\n9. History of infectious diseases, such as positive HIV antibody test, active hepatitis B (defined as HBsAg positive during screening, with HBV-DNA levels above the upper limit of normal at the local laboratory), or hepatitis C (defined as positive HCV-Ab test during screening with positive HCV-RNA).\n10. Other conditions considered by the investigator to potentially affect patient compliance or make the patient unsuitable for participation in this study.",{"count":487,"type":22},20,[25],"This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r\u002Fm HNSCC patients.",[109,491,492],"Oncolytic Virus","TACE",{"date":494,"type":33},"2026-07-17",{"date":496,"type":33},"2026-03-02",{"date":498,"type":22},"2028-12-15",{"name":39,"class":40},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":95},"100629304","phase-2-vebotolimab-combined-with-ptorlimab-for-egfr-positive-refractory-advanced-biliary-tract-malignancies-100629304","NCT07472933","Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies","An Exploratory Study of Vedotin-tislelizumab Combined With Toripalimab in EGFR-positive Refractory Advanced Biliary Tract Malignancies","Inclusion Criteria\n\n1. Age 18 to 75 years, regardless of gender;\n2. Patients with locally advanced or metastatic biliary tract malignancies confirmed by histopathological or cytological examination;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n4. EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathology laboratory;\n5. Previously received at least one line of systemic therapy;\n6. At least one measurable target lesion assessable by CT or MRI according to RECIST 1.1 criteria;\n7. Laboratory parameters meeting the following requirements:\n\n   ① Bone marrow function: hemoglobin (Hb) ≥90 g\u002FL; white blood cell count (WBC) ≥lower limit of normal; absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count ≥75×10⁹\u002FL;\n\n   ② Renal function: creatinine (Cr) ≤ upper limit of normal (ULN) ×1.5; creatinine clearance (Ccr) ≥55 mL\u002Fmin;\n\n   ③ Liver function: total bilirubin ≤ULN ×1.5; ALT and AST ≤ULN ×2.5; (for intrahepatic cholangiocarcinoma or patients with liver metastases, total bilirubin must not exceed 3 times ULN, and transaminases must not exceed 5 times ULN);\n\n   ④ Coagulation function: international normalized ratio (INR) ≤ULN ×1.5, and activated partial thromboplastin time (aPTT) within normal range;\n8. Female of childbearing potential agrees to use effective contraception during the study and for 6 months after study completion; negative serum or urine pregnancy test within 7 days prior to enrollment, and non-lactating; male participants agree to use effective contraception during the study and for 6 months after study completion;\n9. No participation in other clinical trials involving investigational drugs within 4 weeks prior to enrollment;\n10. The subject understands the study and voluntarily signs an informed consent form;\n11. No severe complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever \\>38°C unrelated to cancer;\n12. Expected good compliance, able to follow up for efficacy and adverse events as per protocol;\n13. Estimated survival time greater than 3 months.\n\nExclusion Criteria\n\n1. History of another malignant tumor diagnosed within the past 5 years (except carcinoma in situ, basal cell carcinoma, etc.);\n2. Known central nervous system metastasis (except those with stable disease control and no symptoms after radiotherapy or surgery for at least 4 weeks), or evidence of carcinomatous meningitis;\n3. Presence of psychiatric or neurological disorders preventing cooperation;\n4. Prior exposure to ADC drugs carrying MMAE payload;\n5. Intention to undergo or history of organ or bone marrow transplantation;\n6. Active autoimmune disease or history of autoimmune disease;\n7. Administration of live vaccines within 30 days prior to first dose (use of injectable seasonal influenza vaccine is permitted, as it is an inactivated vaccine);\n8. Uncontrolled cardiac symptoms or disease;\n9. Active infection or fever (excluding documented tumor-related fever);\n10. History or evidence of interstitial lung disease or active non-infectious pneumonia;\n11. Other medical conditions making the patient unsuitable for enrollment, such as immunodeficiency, active tuberculosis, hepatitis B (eligible if HBV-DNA \\\u003C1000 IU\u002FmL after treatment and liver function is normal), positive hepatitis C virus test, uncorrectable electrolyte disturbances, uncontrollable pericardial effusion, pleural effusion, or ascites;\n12. Allergy to any drug in this regimen;\n13. Use of immunosuppressive drugs or corticosteroids exceeding 10 mg\u002Fday prednisone equivalent dose within 14 days prior to enrollment. (14) Patients who have received radiation therapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment;\n\n(15) Pregnant or breastfeeding women; (16) Patients deemed unsuitable for enrollment by the investigator.",{"count":508,"type":22},49,[25],"This study aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors.",[512],"Cancer of Biliary Duct","2026-07-13",{"date":515,"type":33},"2026-07-14",{"date":114,"type":22},{"date":518,"type":22},"2028-02-29",{"name":39,"class":40},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":145,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":535,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":95},"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":528,"type":22},18,[80],"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?",[333,532,533,534],"Solid Tumor Cancer","Peptides","Cancer Metastatic",[336,536,537,538],"Cancer metastasis","Solid tumor","IL-22","2026-07-12",{"date":515,"type":33},{"date":513,"type":33},{"date":543,"type":22},"2027-12-30",{"name":39,"class":40},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":561,"leadSponsor":563,"locationsCount":4},"100647193","early-phase-1-safety-and-efficacy-of-the-bispecific-t-cell-engager-bite-as-conditioning-regimen-for-abo-incompatible-living-donor-kidney-transplantation-100647193","NCT07706205","Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation","Inclusion Criteria:\n\n1. Age ≥18 years old and ≤65 years old, regardless of gender\n2. End-stage renal disease (ESRD) diagnosed clinically and pathologically, estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m², or undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for ≥3 months\n3. Plan to receive ABO-incompatible living donor kidney transplantation (ABOi-LDKT), and the matching has been approved by the organ transplantation ethics committee and technical committee of the hospital\n4. Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method)\n5. able to understand study procedures, provide written informed consent, and be willing and able to comply with the study visit schedule and laboratory examination requirements\n\nExclusion Criteria:\n\n1. patients allergic to the components of rituximab, teritumumab and berintuomab;\n2. Hematologic diseases or myelosuppression (ANC \\\u003C 1.0×10⁹\u002FL, PLT \\\u003C 75×10⁹\u002FL);\n3. multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time;\n4. acute active infection (including HBV, HCV, HIV, uncontrolled bacterial\u002Ffungal infection);\n5. Severe cardiac dysfunction (NYHA class III-IV)\n6. known or suspected hereditary complement deficiency\n7. abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or glutamyl transpeptidase (GGT) \\> 3 times the upper limit of normal (ULN); Or alkaline phosphatase (ALP) or total bilirubin values greater than 1.5 times the upper limit of normal (ULN).\n8. Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc.\n9. complicated with other uncontrolled malignant tumors;\n10. women who are pregnant, breastfeeding or planning to become pregnant;\n11. patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases;\n12. Patients who were not eligible for the study for other reasons according to the investigator's judgment.","65 Years",{"count":487,"type":22},[554],"EARLY_PHASE1","The goal of this clinical trial was to determine whether the Bites drugs (Blinatumomab and Teclistamab) can reduce blood group antibodies in recipients of living donor blood-incompatible kidney transplants for pretransplant conditioning. It will also understand the safety of Bites drugs in the transplant population. The main questions it aims to answer include:\n\nCan Bites effectively reduce blood group antibodies? What are the safety concerns that participants may have when using Bites?\n\nParticipants will:\n\nBe given Blinatumomab and Teclistamab at the standard dose prescribed by the manufacturer before surgery, and blood group antibodies were rechecked every two weeks to two months.\n\nThe adverse drug reactions and the times of rescue were recorded.",[557],"ABO Blood Type Incompatible Kidney Transplantation","2026-07-09",{"date":472,"type":33},{"date":65,"type":22},{"date":562,"type":22},"2028-12-31",{"name":39,"class":40},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":164,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":95},"100647110","phase-2-superoxide-dismutase-skin-spray-for-the-prevention-of-acute-radiation-dermatitis-in-head-and-neck-cancer-100647110","NCT07704372","Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer","Superoxide Dismutase Skin Spray for Reducing Acute Radiation Dermatitis in Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n1. Histologically confirmed malignant tumors of the head and neck without distant metastasis.\n2. Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.\n3. Age 18-80 years at the time of consent.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Signed informed consent form.\n6. Adequate cognitive and reading abilities to complete the questionnaire.\n\nExclusion Criteria:\n\n1. Pre-existing skin disease or open wounds in the irradiation field.\n2. Have a history of head and neck radiotherapy.\n3. Autoimmune or connective tissue disorders affecting skin.\n4. Known allergy to any component of study formulations.\n5. Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.",{"count":166,"type":22},[25],"To evaluate the efficacy and safety of superoxide dismutase skin spray for the reducing the acute radiation dermatitis in patients with head and neck malignancies undergoing radiotherapy.",[575],"Radiation-induced Dermatitis",[577,575,578],"Head & neck cancer","superoxide dismutase",{"date":472,"type":33},{"date":472,"type":22},{"date":582,"type":22},"2027-04-30",{"name":39,"class":40},""]