[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital of Bengbu Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":171},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,66,93,122,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100520826","early-phase-1-safety-and-efficacy-study-of-nggt002-in-pku-adult-subjects-100520826",false,"NCT06061614","Safety and Efficacy Study of NGGT002 in PKU Adult Subjects","A Clinical Study for the Safety and Efficacy of IV Infusion of NGGT002 in the Treatment of Phenylketonuria","Inclusion Criteria:\n\n* Voluntarily sign informed consent form;\n* Male and female subjects with diagnosis of PKU caused by confirmed phenylalanine hydroxylase(PAH) mutation according to the \"Clinical Practice Guidelines for Phenylketonuria, 2020 Edition\";\n* Age ≥ 18 years;\n* Blood phenylalanine (Phe) concentration ≥ 600 μmol\u002FL at least once within 2 years prior to screening, with one measurement confirmed within six months of enrollment;\n* Subjects are able to maintain their baseline diet throughout the study (regardless of dietary phenylalanine restriction), and willingness to follow the instruction of investigators to manage the diet for the duration of the trial;\n* Subjects are required to obtain approval from the investigator prior to the use of any concomitant medications during the study period;\n* Willingness and capable per Investigator opinion to comply with study procedures and requirements;\n* Female participants of childbearing potential must have abstained from unprotected sexual intercourse for at least 14 days prior to dosing, and must have a documented negative serum hCG test between Day -7 and Day 0. All participants must be willing to use a highly effective method of contraception for at least 12 months following NGGT002.\n\nExclusion Criteria:\n\n* Anti-AAV8 neutralizing antibody\\>1:10\n* Prior gene therapy\n* Positive hepatitis B virus surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or treponema pallidum-specific antibody\n* Hepatic function abnormal: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 1.5 × ULN; alkaline phosphatase (ALP) \\> 1.5 × ULN; total bilirubin (TBil) \\> 1.5 × ULN; international normalized ratio (INR) \\> 1.3\n* Hematology values outside of the normal range (Hemoglobin \\\u003C 110 g\u002FL (male), \\\u003C 100 g\u002FL (female), white blood cells \\\u003C 3.0 × 10\\^9\u002FL, neutrophils \\\u003C 1.5 × 10\\^9\u002FL, platelet counts \\\u003C 100 × 10\\^9\u002FL;\n* Hemoglobin A1c \\> 6%, or fasting glucose \\> 6.1 mmol\u002FL;\n* Clinically significant abnormalities in vital signs, physical examination findings, laboratory tests, or other assessments that, in the Investigator's judgment, are deemed unsuitable for study enrollment;\n* Any contraindications to corticosteroid use or conditions potentially worsened by corticosteroids, as assessed by the Investigator, including but not limited to hypersensitivity to glucocorticoids, epilepsy, recent or unresolved bone fractures, ongoing wound healing, uncontrolled infections, or clinically significant osteoporosis;\n* Subjects with a history of allergy to human serum albumin;\n* All types of past and current malignancy;\n* Severe diseases in the cardiovascular, respiratory, digestive tract, endocrine, kidney, blood, nervous, mental and other systems before screening;\n* Subjects with history of live diseases, such as hepatitis, liver cirrhosis, liver cancer or other serious liver diseases;\n* Subjects who participated in other clinical trails and took drugs within 3 months before screening;\n* Other conditions that the Investigators deemed inappropriate for enrollment.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is a single-center, open-label, non-randomized, dose escalation study to evaluate the safety, tolerability and efficacy of NGGT002 in adult Phenylketonuria (PKU) subjects. All subjects will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years.",[26],"Phenylketonurias",[28],"Phenylalanine hydroxylase (PAH) Deficiency","RECRUITING","2026-03-02",{"date":32,"type":33},"2026-03-04","ACTUAL",{"date":35,"type":33},"2023-03-30",{"date":37,"type":20},"2028-12-30",{"name":39,"class":40},"The First Affiliated Hospital of Bengbu Medical University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100616023","phase-2-an-exploratory-study-on-individualized-neoadjuvant-treatment-regimens-for-early-hrher2-breast-cancer-100616023","NCT07300215","An Exploratory Study on Individualized Neoadjuvant Treatment Regimens for Early HR+\u002FHER2+ Breast Cancer","Inclusion Criteria:\n\n* The patient must meet all of the following criteria to be included in the study:\n\n  1. The tumor stage must be in accordance with the 8th edition of the AJCC standard, being stage II-III for the initial diagnosis;\n  2. The age must be between 18 and 75 years (inclusive of 18 and 75), and the patient must be female;\n  3. All patients must have been pathologically confirmed as HR+\u002FHER2+. The estrogen receptor (ER) must be positive (\\>10%) or the progesterone receptor (PR) must be positive (\\>10%), and the HER2 must be positive. HER2 positivity is defined as an immunohistochemistry (IHC) score of 3+, or a score of 2+ and positive in in situ hybridization (ISH) (ISH amplification rate ≥ 2.0);\n  4. The ECOG score must be 0-1;\n  5. According to the RECIST 1.1 standard, there must be at least one measurable lesion;\n  6. The functional levels of the organs must meet the following requirements: (a) Blood routine: ANC ≥ 1.5×109\u002FL; PLT ≥ 90×109\u002FL; Hb ≥ 90g\u002FL; (b) Blood biochemistry: TBIL ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; BUN and Cr ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL\u002Fmin; (c) Cardiac echocardiography: Left ventricular ejection fraction ≥ 50%:\n  7. The subject voluntarily joins this study, signs the informed consent, has good compliance and is willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* (1) Has received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) in the past; (2) Is currently receiving other anti-tumor drug treatment; (3) Has had any other malignant tumor within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, or minimally invasive papillary thyroid cancer after radical surgery; (4) Has severe dysfunction of important organs such as the heart, liver, and kidneys; (5) Has difficulty swallowing, chronic diarrhea, and intestinal obstruction, and has multiple factors that affect the administration and absorption of the drugs; (6) Has participated in other drug clinical trials within 4 weeks before enrollment and has received the investigational drugs; (7) Has a history of immunodeficiency diseases, including positive HIV test, HCV, active viral hepatitis, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation; (8) Has a known history of allergic reaction to the components of this study drug; (9) Has had any heart disease, including: requiring drug treatment or clinically significant arrhythmia; myocardial infarction; heart failure; any other heart disease judged by the investigator as unsuitable for participation in this trial; (10) Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results; (11) According to the investigator's judgment, has serious accompanying diseases that endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.); (12) Has a clear history of neurological or mental disorders, including epilepsy or dementia; (13) The investigator deems that the patient is not suitable for participating in this study in any other circumstances.","FEMALE","75 Years",{"count":51,"type":20},60,[53],"PHASE2","HR+\u002FHER2+ breast cancer belongs to a special type of tumor with dual-channel signal activation. However, in clinical treatment, the preferred approach is usually the inhibition of the HER2 signaling pathway. Therefore, the non-pCR rate after neoadjuvant therapy is relatively high (about 60%). To optimize the neoadjuvant treatment strategy for HR+\u002FHER2+ breast cancer, increase the pCR rate of neoadjuvant treatment, and improve the prognosis of patients, our research group intends to conduct a prospective clinical and translational study. By observing the clinical efficacy and changes in biomarkers, individualized treatment for HR+\u002FHER2+ breast cancer will be carried out. Patients who respond well to HER2-targeted therapy will be identified early, and for those without early relief, targeted combined dual-channel inhibition therapy with endocrine treatment will be adopted. The effectiveness and safety of the individualized neoadjuvant treatment strategy for HR+\u002FHER2+ breast cancer patients will be evaluated. In addition, this study aims to focus on the neoadjuvant chemotherapy mechanism of HR+\u002FHER2+ breast cancer, and combine the establishment and validation of effective disease models to provide theoretical basis and experimental support for achieving precise treatment and clinical transformation.",[56],"Breast Cancer","NOT_YET_RECRUITING","2025-12-10",{"date":60,"type":33},"2025-12-23",{"date":62,"type":20},"2025-12-20",{"date":64,"type":20},"2027-11-01",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":41},"100589667","mechanisms-and-interventions-of-social-reward-on-cognitive-control-in-internet-gaming-disorder-100589667","NCT06957392","Mechanisms and Interventions of Social Reward on Cognitive Control in Internet Gaming Disorder","Mechanisms and Interventions of Social Reward Modulating Cognitive Control in Internet Gaming Disorder Via the dACC-DLPFC Circuit","Inclusion Criteria:\n\n* Individuals aged between 18 and 35 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.\n* Consent to actively cooperate in the completion of subsequent follow-up assessments.\n* All are right-handed\n* The Gaming Disorder Screening (GDSS) Scale score ≥ 47 points;\n* The main game played is Honor of Kings; Average weekly gaming time (Honor of Kings) greater than 21 hours, maintained for over one year; More than 50% of daily internet time spent playing online games;\n\nExclusion Criteria:\n\n* Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.\n* A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.\n* Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.\n* Severe organic diseases that might compromise study participation.\n* Color blindness or color weakness","35 Years",{"count":51,"type":20},[76],"NA","Internet Gaming Disorder (IGD) involves impaired cognitive control linked to reduced social reward and dACC-DLPFC brain circuit dysfunction. Enhancing social reward may restore this circuit and improve symptoms. This study uses psychological interventions and neuroimaging to explore and treat IGD.",[79],"Internet Gaming Disorder",[81,82,83,84],"Internet gaming disorder","Cognitive control","dACC-DLPFC","Social reward","2025-05-03",{"date":87,"type":33},"2025-05-07",{"date":89,"type":33},"2024-12-25",{"date":91,"type":20},"2026-12-25",{"name":39,"class":40},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100589805","risk-stratification-via-hf-qrs-and-fibrosis-biomarkers-in-heart-failure-100589805","NCT06959186","Risk Stratification Via HF-QRS and Fibrosis Biomarkers in Heart Failure","High-Frequency QRS and Fibrosis Biomarkers for Risk Stratification in Chronic Heart Failure: A Multicenter Prospective Cohort Study","STRIVE","Inclusion Criteria：\n\n1. Age ≥18 years and ≤85 years\n2. Diagnosis of chronic heart failure (CHF) based on ESC 2021 and AHA\u002FACC\u002FHFSA 2022 guidelines\n3. Presence of typical symptoms (e.g., exercise intolerance, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, or fatigue) and signs (e.g., lower extremity edema, jugular venous distension, pulmonary rales)\n4. Elevated NT-proBNP (\\>125 pg\u002FmL, adjusted for BMI if \\>25 kg\u002Fm²)\n5. Evidence of structural or functional cardiac abnormalities by echocardiography (LVEF ≤50%, E\u002Fe' \\>14, e' \\\u003C9 cm\u002Fs, LV hypertrophy, or left atrial enlargement)\n6. For HFpEF patients (LVEF ≥50%), at least one additional echocardiographic abnormality is required\n\nThe Main Exclusion Criteria:\n\n1. End-stage renal disease requiring dialysis\n2. Severe chronic pulmonary disease (e.g., moderate-to-severe COPD, pulmonary fibrosis)\n3. Active malignancy or life expectancy \\\u003C1 year\n4. Severe anemia (Hb \\\u003C8 g\u002FdL) or uncontrolled thyroid dysfunction\n\n4\\. Cardiogenic shock or need for mechanical ventilatory support 5. Severe cognitive impairment, psychiatric illness, or inability to comply with study procedures 6. Other non-cardiac causes that may mimic heart failure symptoms (e.g., advanced liver cirrhosis)","85 Years",{"count":103,"type":20},1500,"OBSERVATIONAL","This study aims to evaluate whether high-frequency QRS (HF-QRS) signal parameters and circulating myocardial fibrosis biomarkers (such as PIIINP, Galectin-3, and sST2) can improve risk stratification in patients with chronic heart failure (CHF). In this prospective, multicenter cohort study (STRIVE cohort), patients with CHF will be enrolled and followed for 18 months. Clinical data, routine heart function measures (such as NT-proBNP and LVEF), HF-QRS features from standard 12-lead ECG, and serum fibrosis biomarker levels will be collected. The study will assess the association of HF-QRS abnormalities and fibrosis biomarker levels with major clinical outcomes, including cardiovascular mortality, first heart failure-related rehospitalization, malignant arrhythmia events, all-cause rehospitalization and mortality. By integrating electrophysiological and molecular markers, this research aims to develop a novel, non-invasive predictive model to support early risk identification and personalized management of heart failure patients.",[107],"Heart Failure",[107,109,110,111,112,113],"Myocardial Fibrosis","high-frequency QRS","biomarker","rehospitalization","mortality","2025-04-28",{"date":116,"type":33},"2025-05-06",{"date":118,"type":20},"2025-06-30",{"date":120,"type":20},"2026-12-31",{"name":39,"class":40},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":41},"100454073","phase-2-albumin-bound-paclitaxel-combined-with-antiangiogenic-agents-in-first-line-treatment-of-relapsed-or-metastatic-tnbc-100454073","NCT05192798","Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC","A Prospective, Randomized, Open Label Clinical Study Evaluating Efficacy and Safety of Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic Triple Negative Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤80 years;\n2. Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;\n3. Presence of at least one measurable lesion according to RECIST 1.1;\n4. Expected survival ≥3 months;\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) : 0-2;\n6. Patients who have not previously received antitumor systemic therapy for the stage of relapse or metastasis;\n7. For subjects who have previously undergone adjuvant\u002Fneoadjuvant therapy, the time from the end of the last chemotherapy (including taxanes) to randomization should be ≥12 months; The time from the end of radical radiotherapy to randomization should be ≥6 months.\n8. Major organs show good function, and the relevant examination indexes within 7 days prior to randomization meet the following requirements:\n\n   * Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002F L;\n   * Platelet count ≥ 100 x 10\\^9 \u002F L;\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5 × upper limit of normal (ULN); ALT and AST≤5 × ULN if liver metastasis is present;\n   * Creatinine clearance rate(Ccr) ≥60 mL\u002Fmin according to the Cockcroft-Gault formula;\n   * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN, and international normalized ratio (INR)≤1.5 × ULN.\n9. Subjects voluntarily agree to participate in the study and sign informed consent, with good compliance and being accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breast-feeding;\n2. Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);\n3. Known hypersensitivity reaction to any of the components of the treatment;\n4. Peripheral neuropathy ≥ grade 2, whatever the cause;\n5. Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \\\u003C50 at rest) or heart rate-corrected QT interval via Fridericia (QTcF) ≥470 msec.\n6. Patients with urinary protein ≥++ indicated by routine urine examination, and the 24-hour urine protein level was confirmed to be \\> 1.0g;\n7. Patients with imaging showing that the tumor has invaded important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;\n8. Patients who have experienced arteriovenous or venous thrombosis events within 6 months prior to randomization, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;\n9. Any bleeding or bleeding event ≥grade 3 within 4 weeks prior to the first dose of therapy; Or the presence of unhealed wounds, fractures, gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;\n10. Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires frequent drainage procedures;\n11. Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;\n12. Participants in clinical trials of other antitumor drugs within 4 weeks prior to randomization;\n13. Other circumstances in which participation in the study would be inappropriate as determined by the investigator.","80 Years",{"count":131,"type":20},128,[53],"This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg\u002Fm2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg\u002Fm2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg\u002Fm2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg\u002Fkg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression\u002Fdeath\u002Ftoxicity was intolerable\u002Fthe patient or investigator decided to discontinue the medication.\n\nThe primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR, complete response (CR)+ partial response (PR) + stable disease (SD, \\> 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.",[135],"Triple-negative Breast Cancer",[137,138,139,140,141],"Triple-negative breast cancer","Albumin-bound paclitaxel","Bevacizumab","Apatinib","First-line therapy","2025-02-25",{"date":144,"type":33},"2025-02-27",{"date":146,"type":33},"2022-01-14",{"date":148,"type":20},"2025-12-01",{"name":39,"class":40},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100535574","phase-2-efficacy-and-safety-of-intratumoral-injection-of-recombinant-human-adenovirus-type-5-combined-with-tislelizumab-and-lenvatinib-in-the-treatment-of-advanced-hepatocellular-carcinoma-100535574","NCT06253598","Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma","Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma: a Single-center, Prospective, Single-arm Study","Inclusion Criteria:\n\n1. Age ≥18 years old, and ≤75 years old, regardless of gender;\n2. Primary hepatocellular carcinoma confirmed by histology or imaging;\n3. Patients with advanced hepatocellular carcinoma who have not received oncolytic viruses, immutherapy drugs (including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs), and systemic therapy (such as anti-VEGF \u002FVEGFR monoclonal antibodies, anti- VEGFR-TKI drugs, chemotherapy);\n4. ECOG performance status 0-1;\n5. Child-Pugh score ≤7;\n6. There was at least one measurable target lesion according to RECIST 1.1 criteria, and at least one lesion was ≥ 10 mm;\n7. The expected survival time was ≥3 months;\n8. Laboratory tests during the screening period met the following criteria:\n\n   i. White blood cell count ≥ 3.0×10\\^9 \u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥ 75×10\\^9\u002FL, hemoglobin \\> 90g\u002FL\n\n   ii. INR≤1.5 and APTT≤1.5 times upper limit of normal or partial prothrombin time (PTT) ≤1.5 times upper limit of normal;\n\n   iii. Total bilirubin ≤2.5 times upper limit of normal; ALT and AST≤5 times upper limit of normal (ULN); Serum creatinine ≤1.5 times the upper limit of normal.\n9. They volunteered to participate in this study and signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, men or women unwilling to use effective contraception;\n2. Diffuse liver cancer or tumor is not suitable for RECIST 1.1 criteria;\n3. Patients who have previously received an oncolytic viral agent such as T-VEC;\n4. Known allergy to the study drug or its active ingredient, history of allergy to the same biological agent;\n5. HBV DNA quantitation ≥1000 copies.\n6. Imaging showed portal vein tumor thrombus more than half of the lumen, inferior vena cava tumor thrombus or heart involvement.\n7. The patient has had grade ≥2 hepatic encephalopathy within 12 months or currently requires medication to prevent or control hepatic encephalopathy.\n8. Confirmed active tuberculosis (TB), known human immunodeficiency virus (HIV) positive patients, and other serious infections requiring treatment;\n9. A history of immunodeficiency or autoimmune disease, or long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days before enrollment;\n10. A history of other (including unknown primary) malignancies, except for Cured non- melanoma skin malignancies, carcinoma in situ of the cervix, radical stage I uterine cancer, radical ductal carcinoma in situ or lobular carcinoma in situ of the breast (without any systemic treatment), localized prostate cancer that is currently considered cured after radical surgery, and other solid tumors that have been treated with radical surgery for more than 5 years without evidence of recurrence;\n11. Known tumors of the central nervous system, including metastatic brain tumors;\n12. Accompanied by any unstable systemic disease, including but not limited to: Severe infections, patients with hypertension whose blood pressure cannot be lowered to normal after antihypertensive treatment, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction (a history of myocardial infarction of 6 months or more is allowed), congestive heart failure, serious arrhythmias requiring medical treatment, renal or metabolic diseases;\n13. With medical contraindications to any contrast-enhanced imaging (CT or MRI);\n14. Participants who had participated in an interventional clinical trial within 30 days before screening (Note: Participants who were already in the follow-up phase of the clinical trial could participate in this trial if it was 4 weeks after the last dose of the previous investigational drug).",{"count":158,"type":20},30,[53],"This prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .",[162],"Hepatocellular Carcinoma","2024-03-06",{"date":165,"type":33},"2024-03-07",{"date":167,"type":20},"2024-03-30",{"date":169,"type":20},"2026-12-30",{"name":39,"class":40},""]