[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing 302 Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":556},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,40,50,90,117,145,172,197,217,244,269,296,318,340,361,385,405,426,450,471,485,507,536],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053916","phase-2-targeted-therapies-for-immunological-non-responders-in-people-with-hiv-a-multicenter-clinical-study-100053916",false,"NCT07637877","Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study","Inclusion Criteria:\n\n1. Patients with incomplete immune reconstitution, aged between 18 and 65 years (inclusive).\n2. At enrollment, have received antiretroviral therapy (ART) for more than 4 years, with plasma HIV-RNA below the lower limit of detection (VL \\\u003C 50 copies\u002FmL) for more than 3 years, while CD4⁺ T cell count remains persistently below 350 cells\u002FμL.\n3. Within 1 year prior to enrollment, CD4⁺ T cell count remains persistently below 350 cells\u002FμL but above 200 cells\u002FμL.\n4. Currently receiving a dolutegravir (DTG)-based ART regimen (e.g., DTG plus lamivudine, or the fixed-dose combination DTG\u002F3TC\u002FABC) for ≥ 1 year, with no relevant drug resistance detected by high-precision resistance testing; no change in the core ART regimen within 1 year prior to enrollment (adjustments of auxiliary medications for side effect management are permitted); and agree to continue the current integrase inhibitor-based regimen for at least 1 year after enrollment.\n5. Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Co-infection with other viruses: positive for any of HBV, HCV, HDV, or HEV; or CMV\u002FEBV viral load \\> 1000 copies\u002FmL.\n2. HIV-2 infection alone or co-infection with HIV-1 and HIV-2.\n3. History of using efavirenz or rilpivirine within 2 years prior to enrollment.\n4. History of NNRTI resistance.\n5. Clinical signs suggestive of other serious diseases.\n6. Long-term use of corticosteroids or other immunosuppressive agents.\n7. Co-existing severe AIDS-related or non-AIDS-related events.\n8. Co-existing severe underlying diseases of other systems not related to AIDS.\n9. Other severe organic diseases or psychiatric disorders, including any uncontrolled clinically significant disease of the urinary, circulatory, respiratory, nervous, psychiatric, digestive, endocrine, immune systems, or malignancy.\n10. Receipt of immunosuppressive or systemic cytotoxic therapy within 6 months prior to screening.\n11. Evidence of substance abuse within 6 months prior to enrollment, or a positive urine drug screen.\n12. Current participation in another clinical trial that may conflict with the treatment protocol or outcome measures of this study.\n13. Pregnancy, breastfeeding, or women who have a desire to become pregnant.\n14. Inability or unwillingness to provide informed consent or comply with study requirements.\n15. Any other serious condition that may interfere with the conduct of the clinical trial.","ALL","18 Years","60 Years",{"count":19,"type":20},21,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study focuses on people with HIV who experience incomplete immune reconstitution despite suppressive antiretroviral therapy (ART), characterized by persistently low CD4⁺ T cell counts and residual inflammation. The underlying cause is largely attributed to the persistent HIV latent reservoir. Recent evidence indicates that rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) commonly used in ART, has an immunomodulatory function beyond its antiviral activity. It activates the CARD8 inflammasome - an intracellular \"kill switch\" - triggering pyroptosis selectively in HIV-infected cells. In this study, rilpivirine will be added to suppressive ART in patients with incomplete immune reconstitution. The investigators hypothesize that this strategy will reduce the latent reservoir, restore CD4⁺ T cell counts and function, attenuate excessive immune activation, and ultimately improve long-term clinical outcomes.",[26],"Immunological Non-Responders in People With HIV","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-06-15",{"date":35,"type":20},"2029-01-30",{"name":37,"class":38},"Beijing 302 Hospital","OTHER",5,{"id":41,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":42,"targetDuration":4,"studyType":21,"phases":43,"briefSummary":24,"conditions":44,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":45,"startDateStruct":47,"completionDateStruct":48,"leadSponsor":49,"locationsCount":39},"100641740",{"count":19,"type":20},[23],[26],{"date":46,"type":31},"2026-06-16",{"date":33,"type":31},{"date":35,"type":20},{"name":37,"class":38},{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100626800","teas-for-sedation-during-ercp-a-multicenter-trial-with-mechanistic-substudy-100626800","NCT07440342","TEAS for Sedation During ERCP: A Multicenter Trial With Mechanistic Substudy","Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Conscious Sedation for Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Sham-Controlled, Multicenter Trial With Mechanistic Substudy","TEAS-ERCP-MC","1\\. Inclusion Criteria:\n\n1. Patients aged 18-85 years scheduled for elective diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for pancreaticobiliary indications.\n2. American Society of Anesthesiologists (ASA) physical status classification I, II, or III.\n3. Body mass index (BMI) between 18 and 30 kg\u002Fm².\n4. Willing and able to provide written informed consent.\n\n2\\. Exclusion Criteria:\n\n1. Known allergy or contraindication to meperidine, diazepam, or any other medication used in the protocol.\n2. Chronic use of benzodiazepines or opioids (regular use more than three times per week in the preceding three months).\n3. Severe cardiopulmonary, hepatic, or renal dysfunction (e.g., New York Heart Association class III or IV heart failure, uncontrolled chronic obstructive pulmonary disease, estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m², active liver disease).\n4. Anticipated difficult airway (Mallampati score IV, mouth opening \\\u003C3 cm, thyromental distance \\\u003C6 cm).\n5. Untreated or severe obstructive sleep apnea requiring continuous positive airway pressure therapy.\n6. Pregnancy or breastfeeding.\n7. Psychiatric or cognitive disorders precluding cooperation or valid assessment (e.g., severe anxiety, cognitive impairment).\n8. Pre-induction resting heart rate \\\u003C50 beats per minute or second-degree or higher atrioventricular block.\n9. Conditions predisposing to aspiration (e.g., gastric outlet obstruction, previous esophageal or gastric surgery with delayed emptying).\n10. Previous exposure to transcutaneous electrical acupoint stimulation or knowledge of TEAS that could compromise blinding for the sham procedure.\n11. Skin lesions, infections, or electronic implants at or near the proposed acupoint locations.\n12. Inability to provide informed consent.\n\n3\\. Dropout Criteria:\n\n1. Requirement for conversion to general anesthesia due to failed sedation or clinical necessity.\n2. Occurrence of a serious adverse event related to the study intervention (e.g., severe allergic reaction, hemodynamic collapse).\n3. Life-threatening deterioration during endoscopy (e.g., uncontrolled bleeding, respiratory failure, cardiac arrest).\n4. Voluntary withdrawal of consent by participant or legal representative at any time.\n5. Occurrence of a major ERCP-related complication (e.g., perforation, major bleeding, severe pancreatitis) requiring surgical or intensive care intervention.\n6. Principal investigator-identified safety risks (e.g., sepsis, acute liver failure).","85 Years",{"count":60,"type":20},130,[62],"NA","1. The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS), a non-invasive therapy that applies mild electrical current to specific points on the skin, can help patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) better tolerate the procedure and experience fewer complications related to sedation. It will also explore the underlying neuro-endocrine-immune mechanisms by measuring changes in serum biomarkers.\n2. The main questions the study aims to answer are:\n\n(1)Does TEAS reduce the incidence of sedation-related adverse events (such as low blood oxygen, low blood pressure, or breathing problems) during ERCP? (2)Does TEAS improve patient comfort and reduce the need for additional sedative medications during the procedure? (3)Does TEAS lead to faster recovery and higher patient and physician satisfaction? (4) Does TEAS modulate the neuro-endocrine-immune network, as reflected by changes in serum β-endorphin, cortisol, TNF-α, and IL-6 levels?\n\n3.Researchers will compare two approaches:\n\n1. Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP.\n2. Sham TEAS: Pads placed on the same points but no electrical stimulation delivered (the device appears active).\n\n4.All participants will receive standard conscious sedation with meperidine and diazepam, which is commonly used for ERCP in many centers. Participants will be randomly assigned to one of the two groups. The study will measure sedation-related complications, pain levels, medication requirements, recovery times, satisfaction scores, and changes in serum biomarkers (β-endorphin, cortisol, TNF-α, IL-6).",[65,66,67,68],"Endoscopic Retrograde Cholangiopancreatography","Conscious Sedation Adverse Event","Procedural Pain","Sedation-related Complications",[70,71,72,73,74,75,76,77,78,79,80],"Transcutaneous Electrical Acupoint Stimulation","ERCP","Conscious Sedation","Diazepam","Sedation-Related Adverse Events","Acupuncture","Non-Pharmacological Intervention","Neuro-endocrine-immune Mechanisms","Inflammatory Cytokines","Cortisol","β-endorphin","NOT_YET_RECRUITING","2026-06-14",{"date":46,"type":31},{"date":85,"type":20},"2026-09-01",{"date":87,"type":20},"2027-10-01",{"name":37,"class":38},1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":89},"100632526","phase-2-va-cig-regimen-for-previously-untreated-acute-myeloid-leukemia-a-multicenter-prospective-single-arm-trial-100632526","NCT07514832","VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial","A Multicenter, Prospective, Single-Arm Clinical Trial of Venetoclax in Combination With Azacitidine, Cytarabine, Idarubicin and G-CSF (VA-CIG) for Patients With Previously Untreated Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML, excluding acute promyelocytic leukemia) confirmed by morphology, immunophenotyping and molecular genetics, in accordance with the WHO 2022 diagnostic criteria for AML;\n* Age 18-70 years, with no gender restriction;\n* No prior AML-related treatment has been received; exceptions are made for the use of hydroxyurea or similar agents during the diagnostic screening phase to control peripheral blood leukemic blasts;\n* Patients must be assessed as tolerable to intensive chemotherapy regimens; evaluation of tolerance to intensive chemotherapy shall be performed in accordance with the Ferrara 2013 criteria (Appendix A);\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* Serum creatinine ≤ 2.0 × upper limit of normal (ULN), or creatinine clearance \\> 40 mL\u002Fmin calculated by the Cockcroft-Gault formula for glomerular filtration rate (GFR);\n* Total bilirubin ≤ 2 × ULN, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN;\n* Left ventricular ejection fraction (LVEF) ≥ 45%, or LVEF measured by echocardiography (ECHO) within the normal range;\n* Expected survival \\> 3 months.\n\nExclusion Criteria:\n\n* Subjects with a history of myeloproliferative neoplasms (MPNs), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and acute myeloid leukemia (AML) with BCR-ABL1 translocation;\n* Patients with a prior history of venetoclax or azacitidine (Aza) treatment for other diseases;\n* Known hypersensitivity to any component of the investigational medicinal products;\n* History of other concurrent malignancies within 2 years prior to enrollment, except:\n\nAdequately treated carcinoma in situ of the cervix or breast; Basal cell carcinoma or localized squamous cell carcinoma of the skin; Previously controlled malignancies treated with radical surgical resection (or other curative modalities), etc.\n\n* Presence of uncontrolled severe infection or active bleeding;\n* Pregnant or lactating women;\n* Subjects with active, treatment-uncontrolled viral infection caused by HIV, hepatitis B virus, or hepatitis C virus;\n* Subjects with evidence of central nervous system leukemia before treatment initiation;\n* Women of childbearing potential who do not agree to use at least one reliable contraceptive method from Day 1 of the study until 90 days after the last dose of study medication; sexually active male subjects who do not agree to use contraceptive measures from Day 1 of the study until 90 days after the last dose of study medication; male subjects who do not agree to refrain from sperm donation from the start of study drug administration until at least 90 days after the last dose;\n* Subjects with epilepsy requiring pharmacotherapy, dementia, or other abnormal psychiatric conditions that impair the ability to understand or comply with the study protocol;\n* Presence of psychiatric disorders or cognitive impairment that prevents cooperation with treatment and follow-up; conditions limiting oral drug intake or gastrointestinal absorption.","70 Years",{"count":99,"type":20},48,[23],"This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor \\[G-CSF\\]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.",[103],"AML (Acute Myeloid Leukemia)",[105,106,107,108],"AML","Venetoclax","chemotherapy","BCL2 inhibitor","2026-03-31",{"date":111,"type":31},"2026-04-07",{"date":113,"type":20},"2026-04-15",{"date":115,"type":20},"2028-12-31",{"name":37,"class":38},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":89},"100615789","phase-1-phase-1-study-of-chemotherapy-plus-hla-mismatched-gpbmc-infusion-bridging-to-allo-hsct-for-rr-leukemia-100615789","NCT07297173","Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R\u002FR Leukemia","Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia","Inclusion Criteria:\n\n* Age \\>=15 years, male or female, non-limited by race or ethnicity.\n* Confirmed diagnosis of R\u002FR leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.\n* Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\\\u003C= 3 × upper limit of normal(ULN), and total bilirubin \\\u003C= 1.5 × ULN.\n* Adequate renal function including serum creatinine \\\u003C= 2 × ULN or CrCl\\>= 40mL\u002Fmin.\n* LVEF measured by echocardiogram is within the normal range (LVEF \\> 50%).\n* The subject must have one HLA mismatched donor who is \\>= 18 years old to provide GPBMCs for the first-step infusion. If this donor is not qualified as an allo-HSCT donor, the subject must also have another donor who is \\>= 18 years old and qualified as allo-HSCT donor (i.e., matched sibling, 9-10\u002F10 loci matched unrelated, or haploidentical). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. Each subject (or his\u002Fher legal representatives) must sign the Informed Consent Form (ICF), indicating that he\u002Fshe understands the purpose and procedures of research, and is willing to participate in research.\n* Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Uncontrolled infection or hemorrhage.\n* Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.\n* Uncontrolled autoimmune disease or requiring immunosuppression treatment.\n* History of severe blood infusion reaction.\n* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.\n* Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.\n* Major surgery within 4 weeks prior to enrollment.\n* Life-threatening illness other than leukemia or uncontrolled intercurrent illness.","15 Years",{"count":39,"type":20},[127],"PHASE1","This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R\u002FR) leukemia.",[130,131],"Relapsed Leukemia","Refractory Leukemia",[133,134,135,136],"HLA-mismatched GPBMC","allo-HSCT","relapsed leukemia","refractory leukemia","2025-12-09",{"date":139,"type":31},"2025-12-22",{"date":141,"type":31},"2025-12-01",{"date":143,"type":20},"2030-12-01",{"name":37,"class":38},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":89},"100611292","phase-2-venetoclax-containing-therapy-combined-with-microtransplant-for-intermediate-risk-and-higher-mds-100611292","NCT07238686","Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS","Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Intermediate-risk and Higher Myelodysplastic Syndromes","Inclusion Criteria:\n\n* Age \\>=18 years, male or female, non-limited by race or ethnicity.\n* Confirmed diagnosis of MDS according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.\n* Risk stratification according to the Revised International Prognostic Scoring System (IPSS-R) must place the patient in the intermediate-, high-, or very high-risk category.\n* Not candidates for or refuse allogeneic hematopoietic stem cell transplantation.\n* Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\\\u003C= 3 × upper limit of normal(ULN), and total bilirubin \\\u003C= 1.5 × ULN.\n* Adequate renal function including serum creatinine \\\u003C= 2 × ULN or CrCl\\>= 40mL\u002Fmin.\n* LVEF measured by echocardiogram is within the normal range (LVEF \\> 50%).\n* The subject must have one donor who is \\>= 18 years old and HLA matched at 0-7\u002F10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form.\n* Each subject (or his\u002Fher legal representatives) must sign the Informed Consent Form (ICF), indicating that he\u002Fshe understands the purpose and procedures of research, and is willing to participate in research.\n* Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Uncontrolled infection or hemorrhage.\n* Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.\n* Uncontrolled autoimmune disease or requiring immunosuppression treatment.\n* History of severe blood infusion reaction.\n* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.\n* Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.\n* Major surgery within 4 weeks prior to enrollment.\n* Life-threatening illness other than MDS or uncontrolled intercurrent illness.",{"count":153,"type":20},40,[23],"This study aims to evaluate the safety and efficacy of a Venetoclax and hypomethylating agent-based regimen combined with infusion of HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cells (GPBMC) in patients with intermediate-risk and higher myelodysplastic syndromes who are ineligible for allogeneic hematopoietic stem cell transplantation.",[157],"Myelodysplastic Syndromes",[159,160,161,162,163],"venetoclax","hypomethylating agent","GPBMC infusion","microtransplant","microtransplantation","2025-11-20",{"date":166,"type":31},"2025-11-25",{"date":168,"type":31},"2025-06-20",{"date":170,"type":20},"2031-06",{"name":37,"class":38},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":89},"100558879","phase-2-exploration-of-dalpiciclib-plus-hdaci-in-hrher2--advanced-breast-cancer-after-failure-of-cdk46-inhibitor-100558879","NCT06556862","Exploration of Dalpiciclib Plus HDACi in HR+\u002FHER2- Advanced Breast Cancer After Failure of CDK4\u002F6 Inhibitor","Exploration of Dalpiciclib Plus HDACi in HR+\u002FHER2- Advanced Breast Cancer After Failure of CDK4\u002F6 Inhibitor: a Phase II Study","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study and sign the informed consent form\n2. aged ≥ 18 years.\n3. ECOG PS score: 0-2 points.\n4. Expected survival ≥ 6 months.\n5. Regionally recurrent or metastatic disease with histologically or cytologically confirmed ER+ and\u002For PR+ (≥ 10%), HER2- breast cancer that is not suitable for definitive excision or radiation therapy.\n6. Previously received antitumor therapy: 1) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; 2) Disease recurrence and\u002For metastasis during or after treatment with Palbociclib or Abemaciclib or Ribociclib in the setting of (neo-)adjuvant therapy, or during treatment with palbociclib or Abemaciclib or Ribociclib in a metastatic setting or after disease progression; 3) No more than 3 lines of endocrine therapy have been previously received for recurrent or metastatic breast cancer. 4) Line number of previous chemotherapy ≤1 line\n7. At least one extracranial measurable lesion as defined by RECIST v1.1;\n8. The function of vital organs meets the requirements;\n\n   * Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL;\n   * Platelets ≥ 90 × 10\\^9\u002FL;\n   * Hemoglobin ≥ 90g\u002FL;\n   * Total bilirubin (TBIL) ≤ 1.5 × ULN;\n   * ALT and AST ≤ 2.5 × ULN;\n   * Urea\u002Fblood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * The QT correction by the Fridericia formula (QTcF) is \\\u003C 470 ms. INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.\n9. Subject recovers from any AE related to previous antitumor therapy before the first administration of the study drug (Grade ≤ 1)\n\nExclusion Criteria:\n\n1. Previously received treatment with histone deacetylase inhibitor (HDACi);\n2. Previously received Dalpiciclib;\n3. MRI or lumbar puncture confirmed leptomeningeal metastasis;\n4. Central nervous system metastasis is confirmed by imaging; The following conditions will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain metastases, stable for at least 4 weeks, and no symptomatic treatment (including glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical symptoms;\n5. The participants presented with visceral crisis (such as lymphangitis carcinomatosis, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver function), rapid disease progression, and that is not suitable for endocrine therapy;\n6. Participants had ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, which required drainage within 4 weeks before the first medication;\n7. Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;\n8. Subjects that are diagnosed with any other malignancy within 5 years prior to the study, excluding non-melanoma skin cancer treated with radical therapy, basal or squamous cell skin cancer or carcinoma in situ of the cervix and papillary thyroid.\n9. The subject has undergone major surgery or major trauma or is expected to undergo major surgery within 4 weeks before the start of treatment;\n10. A known history of allergy to the drug ingredient of this protocol.",{"count":180,"type":20},155,[23],"A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+\u002FHER2- advanced breast cancer after the failure of CDK4\u002F6 inhibitor therapy.",[184],"HR+\u002FHER2- Advanced Breast Cancer",[186,187,188,189],"post-CDK4\u002F6 inhibitor","Dalpiciclib","HADCi","HR+\u002FHER2- advanced breast cancer","2025-08-08",{"date":192,"type":31},"2025-08-13",{"date":194,"type":20},"2025-10-01",{"date":115,"type":20},{"name":37,"class":38},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":216,"locationsCount":89},"100598984","phase-2-venetoclax-containing-therapy-combined-with-microtransplant-for-newly-diagnosed-aml-100598984","NCT07078591","Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML","Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Age \\>=18 years, male or female, non-limited by race or ethnicity.\n* No prior anti-acute leukemia treatment (including hypomethylators for leukemia or MDS) with the exception that prior hydroxyurea and\u002For leukapheresis are permitted.\n* Confirmed acute myeloid leukemia in accordance with WHO criteria with a WBC count \\\u003C 25 × 109\u002FL.\n* Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\\\u003C= 3 × upper limit of normal(ULN), and total bilirubin \\\u003C= 1.5 × ULN.\n* Adequate renal function including serum creatinine \\\u003C= 2 × ULN or CrCl\\>= 40mL\u002Fmin.\n* LVEF measured by echocardiogram is within the normal range (LVEF \\> 50%).\n* The subject must have one donor who is \\>= 18 years old and HLA matched at 0-7\u002F10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form.\n* Each subject (or his\u002Fher legal representatives) must sign the Informed Consent Form (ICF), indicating that he\u002Fshe understands the purpose and procedures of research, and is willing to participate in research.\n* Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and blast crisis.\n* Uncontrolled infection or hemorrhage.\n* Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.\n* Uncontrolled autoimmune disease or requiring immunosuppression treatment.\n* History of severe blood infusion reaction.\n* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.\n* Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.\n* Any major surgery within 4 weeks before enrollment.\n* Life-threatening illness other than AML or uncontrolled intercurrent illness.",{"count":205,"type":20},50,[23],"The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).",[209],"Acute Myeloid Leukemia",[159,162,163],"2025-07-23",{"date":213,"type":31},"2025-07-28",{"date":168,"type":31},{"date":170,"type":20},{"name":37,"class":38},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":15,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":242,"locationsCount":243},"100587304","a-real-world-study-of-antiviral-therapy-in-children-with-chronic-hepatitis-b-100587304","NCT06926647","A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B","A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B","Inclusion Criteria:\n\n* Initial Treatment Group:\n\n  1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.\n  2. Age: ≥1 year and \\\u003C13 years, either sex;\n  3. Positive for HBsAg and\u002For HBV DNA for more than 6 months;\n  4. No prior antiviral treatment.\n* Treated Group:\n\n  1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.\n  2. Age: ≥3 years and \\\u003C13 years, either sex;\n  3. Previously diagnosed with chronic hepatitis B and received antiviral treatment with NAs for more than 1 year and currently on treatment;\n  4. No history of IFNα use in the past 6 months;\n  5. Negative for HBV DNA;\n  6. HBsAg quantification \\\u003C10,000 IU\u002Fml (HBsAg can be negative in the drug discontinuation observation group);\n  7. The drug discontinuation observation group must also achieve negative HBV DNA and HBeAg seroconversion for at least 1 year (based on continuous results from three consecutive reviews), and HBsAg \\\u003C10,000 IU\u002Fml; NAs will be discontinued after enrollment.\n\nExclusion Criteria:\n\n* 1.In the interferon group, blood white blood cell count \\\u003C3.5×10\\^9\u002FL, or platelet count \\\u003C80×10\\^9\u002FL, or prothrombin activity \\\u003C60%, or total bilirubin \\>34μmol\u002FL, or serum albumin \\\u003C35g\u002FL, or serum creatinine \\>133μmol\u002FL; 2.Coexistence of other active infections; 3. Coexistence of other chronic liver diseases or active liver diseases, such as autoimmune liver disease, drug-induced liver injury, Wilson's disease, decompensated cirrhosis, liver cancer; 4. Coexistence of other severe systemic diseases or malignant tumors, etc.; 5. History of allergy to nucleoside analogues or interferon; 6. Subjects whom the investigator deems to have poor compliance, unable or unwilling to provide informed consent, or unable to adhere to the study requirements, or other conditions not suitable for participation in this study.","1 Year","13 Years",{"count":227,"type":20},2000,"OBSERVATIONAL","This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced patients. The effectiveness and safety of different treatment strategies will be evaluated in children aged 1-12 years with treatment-naive and treatment-experienced chronic hepatitis B (CHB) and chronic HBV infection.",[231,232],"HBV","Chronic Hepatitis b",[234,235],"Nucleos(t)ide Analogues（NAs）","Interferon alpha（IFNα）","2025-04-28",{"date":238,"type":31},"2025-04-29",{"date":240,"type":20},"2025-05-01",{"date":115,"type":20},{"name":37,"class":38},85,{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100583529","rapid-diagnostic-technology-for-augib-based-on-analysis-of-vocs-in-exhaled-breath-100583529","NCT06877507","Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath","Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (VOCs) in Exhaled Breath","VOCsAUGIB","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Clinical suspicion of AUGIB (e.g., hematemesis, melena);\n3. Fasting ≥4 hours;\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Severe pulmonary dysfunction or recent lung infection (within 1 week);\n2. Cardiac\u002Frenal failure or disseminated intravascular coagulation;\n3. Contraindications to endoscopy;\n4. High-risk conditions (e.g., massive ascites);\n5. Alcohol consumption within 24 hours;\n6. Pregnancy.",{"count":253,"type":20},200,"This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.",[256,257],"Volatile Organic Compound","Gastrointestinal Hemorrhage",[256,259,260],"Acute Upper Gastrointestinal Bleeding","Exhaled Breath","2025-03-10",{"date":263,"type":31},"2025-03-14",{"date":265,"type":20},"2025-03-20",{"date":267,"type":20},"2025-07-20",{"name":37,"class":38},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":280,"conditions":281,"keywords":284,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":89},"100573088","phase-2-safety-and-efficacy-of-mitoxantrone-hydrochloride-liposome-based-dcmg-regimen-for-rr-aml-100573088","NCT06741722","Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R\u002FR AML","Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed\u002Frefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* The patient has fully understood the study, voluntarily agrees to participate, and has signed the Informed Consent Form (ICF);\n* Age between 18 and 75 years, with no gender restrictions;\n* Confirmed diagnosis of relapsed\u002Frefractory AML (Acute Myeloid Leukemia) by pathology (meeting any one of the following criteria):\n\n  1. Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity;\n  2. Or patients who meet the diagnostic criteria for recurrent AML, or refractory AML;\n* Serum total bilirubin ≤ 1.5 times the upper limit of normal, serum ALT and AST both ≤ 2.5 times the upper limit of the normal range, serum creatinine ≤ 1.5 times the upper limit of normal;\n* Echocardiogram showing left ventricular ejection fraction (LVEF) ≥ 50%;\n* Estimated survival time ≥ 3 months;\n* ECOG performance status score of 0-2.\n\nExclusion Criteria:\n\n* The subject's prior anti-tumor treatment history meets one of the following conditions:\n\n  1. Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection;\n  2. Previously received doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin \\> 360 mg\u002Fm² (other anthracycline drugs are converted at a ratio of 1 mg doxorubicin equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);\n* Cardiac function and disease meet any of the following conditions:\n\n  1. Long QTc syndrome or QTc interval \\> 480 ms;\n  2. Complete left bundle branch block, second-degree or third-degree atrioventricular block;\n  3. Severe, uncontrolled arrhythmia requiring medication;\n  4. New York Heart Association (NYHA) classification ≥ Class II;\n  5. Ejection fraction (EF) \\\u003C 50% or below the lower limit of normal for the study center's laboratory;\n  6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment, clinically significant pericardial disease, or evidence on electrocardiogram of acute ischemia or active conduction system abnormalities within 6 months prior to enrollment.\n* Underwent any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before the first administration of the study drug;\n* Uncontrolled systemic diseases (such as progressive infections, uncontrolled hypertension, diabetes, etc.);\n* Previous or current diagnosis of other malignancies (excluding adequately controlled basal cell carcinoma of the skin that is non-melanoma, breast\u002Fcervical carcinoma in situ, or other malignancies that have been adequately controlled without treatment in the past five years);\n* Active hepatitis B or C infection during the viremic phase (Hepatitis B testing: if either HBsAg or core antibody is positive, add HBV-DNA testing; viral DNA levels exceeding 1x10\\^3 copies\u002FmL; Hepatitis C testing: if HCV antibody is positive, add HCV-RNA testing; viral RNA levels exceeding 1x10\\^3 copies\u002FmL);\n* Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n* Pregnant women, breastfeeding women, patients who refuse to use effective contraception during the study period;\n* Significant neurological or psychiatric history;\n* Patients deemed unsuitable for participation in this study by the investigator.","75 Years",{"count":278,"type":20},20,[23],"The DCMG regimen includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), comprising four medications. This project initiates a prospective and exploratory clinical study on the DCMG chemotherapy regimen for the treatment of relapsed\u002Frefractory AML (Acute Myeloid Leukemia). The study aims to evaluate the efficacy and safety of the DCMG combination chemotherapy regimen in treating relapsed\u002Frefractory AML.",[105,282,283],"Relapsed Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia",[105,285,209,286,287],"mitoxantrone liposome","relapsed\u002Frefractory AML","DCMG chemotherapy","2024-12-20",{"date":290,"type":31},"2024-12-27",{"date":292,"type":31},"2024-10-31",{"date":294,"type":20},"2027-12-31",{"name":37,"class":38},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":303,"minAge":16,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":89},"100548253","phase-2-adebrelimab-plus-apatinib-and-etoposide-for-the-treatment-of-her2-negative-breast-cancer-brain-metastasis-100548253","NCT06418594","Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis","Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study","Inclusion Criteria:\n\n* Female, aged ≥18 years\n* Expected survival time ≥3 months.\n* Histologically or cytologically confirmed HER2-negative (IHC 0 or 1+; or IHC 2+ ISH negative) locally recurrent or metastatic disease\n* New brain metastasis or brain metastasis progression after treatment\n* HR+ advanced breast cancer with prior CDK4\u002F6 inhibitor treatment failure or the investigator deems unsuitable for CDK4\u002F6 inhibitors\n* At least one intracranial measurable lesion as defined by RECIST V1.1 criteria；\n* ECOG PS 0-2；\n* Patients must have the ability to swallow oral medication；\n* Prior WBRT, stereotactic radiosurgery, and surgical resection are allowed；\n* Organ function levels are basically normal, and the investigator believes that the study drug can be applied：\n* Voluntarily join this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up\n\nExclusion Criteria:\n\n* Urgent need for local treatment of brain metastasis\n* Immunohistochemistry HER2 positive (IHC 3 or IHC 2 ISH amplification)\n* Previously treated with Apatinib, Avelumab, or VP-16；\n* Severe dysfunction of important organs such as the heart, liver, or kidneys；\n* Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug administration and absorption；\n* Participants diagnosed with any other malignant tumor within 5 years before this study, excluding non-melanoma skin cancer that has undergone radical treatment. Basal cell or squamous cell skin cancer or cervical carcinoma in situ and thyroid papillary carcinoma。\n* Patients who allergy to any component of the drugs in this protocol; patients with history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation\n* History of any cardiac disease, including: (1) arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be unsuitable for participation in this trial, etc.\n* Pregnant or lactation female patients; females of childbearing age with a positive baseline pregnancy test or unwilling to take effective contraceptive measures during the entire trial period；\n* According to the investigator's judgment, there are severe accompanying diseases that endanger the patient's safety or affect the completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.).","FEMALE",{"count":305,"type":20},30,[23],"Some studies have shown that approximately 15% of patients with advanced hormone receptor (HR) positive breast cancer and 1\u002F3 of triple negative breast cancer will develop brain metastasis. At present, there is no unified drug treatment standard for HER2-negative breast cancer brain metastasis (BCBM). The evidence of single traditional chemotherapy drug as the main treatment of brain metastasis is not sufficient. Some exploratory studies on HER2-negative BCBM have shown that the central nervous system objective response rate (CNS-ORR) of anti-angiogenic drugs combined with chemotherapy is around 55%-80%。 Adebrelimab (a humanized PD-L1 monoclonal antibody) specifically blocks the binding of PD-1 and PD-L1, terminates the immunosuppressive signal produced by T cells, and makes T cells re-recognize tumor cells and kill them, thereby inhibiting tumor growth. In China, Adebelizumab has been approved for using in combination with chemotherapy as a first-line treatment for extensive stage small cell lung cancer. Apatinib (a small molecule VEGFR tyrosine kinase inhibitor) mainly plays an anti-angiogenic effect in the treatment of malignant tumors by inhibiting VEGFR. Apatinib has been approved monotherapy for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed or relapsed after at least two systematic chemotherapies, advanced liver cancer that has failed or is intolerable after at least first-line systematic treatment, and first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma combined with camrelizumab.\n\nDue to the lack of effective drug therapy for HER2-negative BCBM, a variety of treatment combinations are still being explored. We hypothesized that adebrelimab plus apatinib and etoposide is an explorable and effective treatment for HER2- negative BCBM.",[309],"HER2-negative Breast Cancer Brain Metastases","2024-12-05",{"date":312,"type":31},"2024-12-10",{"date":314,"type":31},"2024-10-10",{"date":316,"type":20},"2026-12-31",{"name":37,"class":38},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":276,"enrollmentInfo":325,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100456543","phase-2-human-umbilical-cord-derived-mesenchymal-stem-cells-for-decompensated-cirrhosis-msc-dlc-2-100456543","NCT05224960","Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Decompensated Cirrhosis Patients(MSC-DLC-2)","Inclusion Criteria:\n\n1. Willing to provide written informed consent;\n2. Aged 18 to 75 years (including 18 and 75 years), male or female;\n3. Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and\u002For representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);\n4. The Model for End-stage Liver Disease (MELD) score 15 to 30 points.\n\nExclusion Criteria:\n\n1. Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.\n2. Uncontrolled severe infection within 2 weeks of screening.\n3. Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.\n4. Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA\\\u003C detection limit without any antiviral treatment).\n5. Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.\n6. Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.\n7. Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.\n8. Significant renal insufficiency (serum creatinine ≥ 1.2 times upper normal limit); Severe electrolyte abnormality (serum sodium level \\\u003C 125 mmol\u002FL); Severe leukopenia (white blood cell count \\\u003C 1 × 10E9\u002FL).\n9. Patients with biliary obstruction, or portal vein spongiosis.\n10. Patients with surgical history such as splenic cut-off flow.\n11. Patients with malignant tumors within 5 years, except those with basal cell carcinoma, squamous cell carcinoma and\u002For carcinoma in situ who had received curative treatment and curative resection.\n12. Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.\n13. Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.\n14. Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.\n15. Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.\n16. Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.\n17. History of pulmonary embolism.\n18. Patients who had previously received stem cell therapy or were intolerant to cell therapy.\n19. The proposed line of liver transplants within three months.\n20. Participants in other clinical trials within the last 3 months.\n21. Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.",{"count":326,"type":20},140,[23],"Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.",[330],"Decompensated Cirrhosis","2024-10-17",{"date":333,"type":31},"2024-10-18",{"date":335,"type":31},"2024-06-27",{"date":337,"type":20},"2027-06-20",{"name":37,"class":38},7,{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":97,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":89},"100551702","phase-1-safety-and-efficacy-of-autologous-tumor-infiltrating-lymphocytes-therapy-in-patients-with-hepatocellular-carcinoma-100551702","NCT06463522","Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Aged 18 to 70 years;\n2. Diagnosis of HCC with BCLC stage B\u002FC;\n3. Anticipated survival time is longer than 3 months;\n4. Liver function grade Child-Pugh A or B, without hepatic encephalopathy;\n5. Left ventricular ejection fraction (LVEF) ≥ 50%;\n6. ECOG physical status 0-2;\n7. Laboratory tests at baseline meet the following: Absolute neutrophil count \\>1.0 x 109\u002FL; Absolute neutrophil count \\>1.0 x 109\u002FL; White blood cell count \\> 2.0 x 109\u002FL; Platelet count \\> 60 x 109\u002FL; Hgb \\> 8.0 g\u002FdL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol\u002FL, or \\\u003C 3 times the ULN.\n8. Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;\n9. Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. WIth HIV\u002FAIDS infection;\n3. Active infection with a temperature \\>38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;\n4. Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;\n5. Subjects undergoing treatment with systemic steroids;\n6. Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening;\n7. Subjects who are allergic to cell therapy products or related drugs;\n8. Subjects who have previously received an organ transplant or are planning to receive an organ transplant;\n9. Subjects requiring anticoagulant therapy (warfarin or heparin);\n10. Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.",{"count":278,"type":20},[127,23],"This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.",[350],"Hepatocellular Carcinoma",[350,352],"Tumor-infiltrating Lymphocytes","2024-08-11",{"date":355,"type":31},"2024-08-13",{"date":357,"type":31},"2024-07-01",{"date":359,"type":20},"2026-07-01",{"name":37,"class":38},{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":97,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":89},"100557349","phase-2-va-combined-with-pd-1-inhibitor-for-the-treatment-of-relapsed-and-refractory-aml-and-high-risk-mds-100557349","NCT06536959","VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS","A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS","Inclusion Criteria:\n\n* Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.\n* Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.\n* Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.\n* The toxic and side effects caused by the last treatment should be recovered.\n* Eastern Cooperative Oncology Group score of 0 to 3 points.\n* The organ function is intact.\n\n  * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).\n  * Creatinine≤2×ULN.\n  * Bilirubin≤2×ULN.\n* Karnofsky≥70.\n* The expected survival period is at least 12 weeks.\n* Non-pregnant, non-breastfeeding women.\n\nExclusion Criteria:\n\n* Suffering from other untreated or unrelieved malignant tumors within 2 years.\n* Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.\n* Suffering from any other known serious and\u002For uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \\[NYHA\\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.\n* Patients who are unwilling or unable to comply with the protocol.\n* Currently being treated with other systemic anti-tumor or anti-tumor research drugs.\n* Women who are pregnant or breastfeeding.",{"count":369,"type":20},67,[23],"The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed\u002Frefractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed\u002Frefractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.",[282,283,157,373],"Minimal Residual Disease",[106,375,376],"Hypomethylation agen","PD-1 inhibitor","2024-07-31",{"date":379,"type":31},"2024-08-05",{"date":381,"type":31},"2024-07-18",{"date":383,"type":20},"2027-07-31",{"name":37,"class":38},{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":224,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":89},"100554800","phase-4-antiviral-therapy-in-infants-with-hbv-infection-100554800","NCT06503796","Antiviral Therapy in Infants With HBV Infection","Inclusion Criteria:\n\n* a. Age ≤ 1 year;\n* b. HBsAg and HBV DNA positive;\n* c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).\n* d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.\n\nExclusion Criteria:\n\n* a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;\n* b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;\n* c. WBC \\\u003C9 × 10\\^9\u002FL, or PLT \\\u003C90 × 10\\^9\u002FL;\n* d. Combination of other systemic serious diseases or hereditary diseases, etc;\n* e. Other conditions deemed by the investigator to be unsuitable for participation in this study.",{"count":392,"type":20},60,[394],"PHASE4","This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and\u002For HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.",[231],"2024-07-21",{"date":399,"type":31},"2024-07-23",{"date":401,"type":20},"2024-08",{"date":403,"type":20},"2026-11",{"name":37,"class":38},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":89},"100551237","sequential-combination-therapy-with-pd-1-antibody-and-peg-ifn-in-chb-patients-100551237","NCT06457477","Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients","The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients","Inclusion Criteria:\n\n* 1\\. 18 - 65 years old;\n* 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);\n* 3\\. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;\n* 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU\u002Fml at Peg-IFNα discontinuation and enrollment.\n\nExclusion Criteria:\n\n* 1\\. Cirrhosis;\n* 2.platelet count \\\u003C 90×109\u002FL, WBC count \\\u003C 3.0×109\u002FL, neutrophil count \\\u003C 1.3×109\u002FL, ALT \\> ULN (40U\u002FL), total bilirubin \\> 2ULN;\n* 3.History of or suspicion of hepatocellular carcinoma\n* 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;\n* 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;\n* 6.Alcohol or drug abuse\u002Fdependence;\n* 7.Investigator judges that the participants are not suitable for this study.","65 Years",{"count":205,"type":20},[62],"This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.",[417],"Chronic Hepatitis B","2024-06-17",{"date":420,"type":31},"2024-06-20",{"date":422,"type":20},"2024-06-15",{"date":424,"type":20},"2025-12-15",{"name":37,"class":38},{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":97,"enrollmentInfo":433,"targetDuration":4,"studyType":21,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":89},"100515004","phase-1-human-umbilical-cord-mesenchymal-stem-cell-transplantation-for-the-treatment-of-acute-on-chronic-liver-failure-100515004","NCT05985863","Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure","Clinical Research of Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure","Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 70 years old, gender is not limited.\n2. Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg\u002Fdl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.\n3. Willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;\n2. Before the onset of liver failure, the previous indicators of the patient included PLT\\\u003C50×10\\^9\u002FL or Child-Pugh score\\>9;\n3. Combined with liver cancer or other malignant tumors;\n4. Patients with previous liver transplantation or planned liver transplantation within 3 months;\n5. Severe organic disease of primary extrahepatic organs;\n6. Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;\n7. Pregnant, breastfeeding women or those who plan to have a baby in the near future;\n8. Those who are highly allergic or have a history of severe allergies;\n9. Those who have received immunosuppressant and immune enhancer treatment within 1 month;\n10. Drug abuse in the past 5 years;\n11. Alcohol withdrawal symptoms;\n12. A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;\n13. Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;\n14. Other conditions that the investigator thinks that the patient is not suitable to participate in this study.",{"count":434,"type":20},150,[127,23],"This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.",[438],"Acute-On-Chronic Liver Failure",[440,438,441],"Mesenchymal Stem Cells","Therapeutics","2024-05-06",{"date":444,"type":31},"2024-05-07",{"date":446,"type":31},"2023-09-30",{"date":448,"type":20},"2028-12-30",{"name":37,"class":38},{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":276,"enrollmentInfo":457,"targetDuration":4,"studyType":21,"phases":459,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":4},"100544124","early-phase-1-allogeneic-gamma-delta-t-cells-combined-with-targeted-therapy-and-immunotherapy-in-a-phase-1-clinical-trial-of-hepatocellular-carcinoma-resistant-to-pd-1-monoclonal-antibody-100544124","NCT06364800","Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody","The Safety and Efficacy Assessment of Allogeneic γδ T Cells Combined With Targeted Therapy and Immunotherapy in Hepatocellular Carcinoma Patients","Inclusion Criteria:\n\n1. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.\n2. Age 18 years up to the age of 75 (≤75), gender unlimited.\n3. Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASL guidelines.\n4. BCLC stage B or C.\n5. Liver function: Child-Pugh class A\u002FB (5-9).\n6. Eastern Cooperative Oncology Group (ECOG) Performance score≤1.\n7. Treated with standard treatment options (anti-PD-1, targeted drugs) ≥3months and experiencing progressive disease according to RECIST 1.1.\n8. Life expectancy ≥ 6 months.\n9. Patients combined with HBV infection require antiviral treatment with nucleoside analogues; patients combined with HCV infection require direct-acting antiviral agent (DAA) treatment.\n10. Adequate organ and marrow function (within 4 weeks prior to study treatment initiation).\n11. Male and female patients of reproductive potential must agree to use birth control during the study and for at least 30 days post study.\n12. Capable of understanding and complying with the study protocol requirements ( including follow-up visit and examinations).\n\nBe willing to signed a written informed consent document before enrollment.\n\nExclusion Criteria:\n\n1. Patients combined with HAV, HEV, HIV or other infectious diseases.\n2. Acute infections, gastrointestinal bleeding, etc. occurred within 30 days before screening.\n3. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.\n4. Major organs dysfunction.\n5. Combined with other severe organic diseases or mental illnesses, including any uncontrolled clinically significant systematic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.\n6. Allergic constitution, history of allergies to blood products, known to be allergic to test substances.\n7. Immunosuppressive or systemic cytotoxic drugs may require within 6 months prior to screening or during the study; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.\n8. Patients currently participating in other clinical trials who may violate this treatment plan and observations.\n9. Those who are unable or unwilling to provide informed consent or who are unable to comply with the research requirements.\n10. Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed: patients with any serious acute or chronic physical or mental illness, or laboratory abnormalities.",{"count":458,"type":20},18,[460],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in patients with hepatocellular carcinoma resistant to PD-1 monoclonal antibody.\n\nHepatocellular Carcinoma",[350],"2024-04-10",{"date":465,"type":31},"2024-04-15",{"date":467,"type":20},"2024-04-26",{"date":469,"type":20},"2026-09-26",{"name":37,"class":38},{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":455,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":276,"enrollmentInfo":477,"targetDuration":4,"studyType":21,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":483,"leadSponsor":484,"locationsCount":4},"100544123","phase-1-allogeneic-gamma-delta-t-cells-combined-with-targeted-therapy-and-immunotherapy-in-a-phase-1-clinical-trial-for-first-line-treatment-of-hepatocellular-carcinoma-100544123","NCT06364787","Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.\n2. Age 18 years up to the age of 75 (≤75), gender unlimited.\n3. Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASL guidelines.\n4. BCLC stage B or C.\n5. Liver function: Child-Pugh class A\u002FB (5-9).\n6. Eastern Cooperative Oncology Group (ECOG) Performance score≤1.\n7. No previous antitumor therapy.\n8. Life expectancy ≥ 6 months.\n9. Patients combined with HBV infection require antiviral treatment with nucleoside analogues; patients combined with HCV infection require direct-acting antiviral agent (DAA) treatment.\n10. Adequate organ and marrow function (within 4 weeks prior to study treatment initiation).\n11. Male and female patients of reproductive potential must agree to use birth control during the study and for at least 30 days post study.\n12. Capable of understanding and complying with the study protocol requirements ( including follow-up visit and examinations).\n13. Be willing to signed a written informed consent document before enrollment.\n\nExclusion Criteria:\n\n1. Patients combined with HAV, HEV, HIV or other infectious diseases.\n2. Acute infections, gastrointestinal bleeding, etc. occurred within 30 days before screening.\n3. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.\n4. Major organs dysfunction.\n5. Combined with other severe organic diseases or mental illnesses, including any uncontrolled clinically significant systematic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.\n6. Allergic constitution, history of allergies to blood products, known to be allergic to test substances.\n7. Immunosuppressive or systemic cytotoxic drugs may require within 6 months prior to screening or during the study; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.\n8. Patients currently participating in other clinical trials who may violate this treatment plan and observations.\n9. Those who are unable or unwilling to provide informed consent or who are unable to comply with the research requirements.\n10. Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed: patients with any serious acute or chronic physical or mental illness, or laboratory abnormalities.",{"count":458,"type":20},[127],"The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in first-line treatment of patients with hepatocellular carcinoma.",[350],{"date":465,"type":31},{"date":467,"type":20},{"date":469,"type":20},{"name":37,"class":38},{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100534393","phase-2-combination-of-atg-based-conditioning-regimen-and-ptcy-for-gvhd-prevention-in-allo-hsct-after-pd-1-blockade-100534393","NCT06238245","Combination of ATG-based Conditioning Regimen and PTCy for GVHD Prevention in Allo-HSCT After PD-1 Blockade","A Prospective, Single-Arm Clinical Study of Anti-thymocyte Globulin-based Conditioning Regimen Combined With Post-Transplantation Cyclophosphamide for GVHD Prevention in Allogeneic HSCT After PD-1 Blockade","Inclusion Criteria:\n\n* (1) age ≥ 18 years old, regardless of gender;\n* (2) patients with hematological malignancies (including lymphoma, leukemia, myelodysplastic syndrome, etc.) who had received at least one course of PD-1 antibody treatment;\n* (3) patients with indications for allo-HSCT, available donors (including matched sibling donors, haploidentical donors and unrelated donors), and no contraindications for transplantation;\n* (4) patients suitable for conventional Bu\u002FFlu conditioning regimen;\n* (5) no serious heart, liver, kidney, lung and other important organ diseases;\n* (6) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;\n* (7) Hematopoietic stem cell transplantation comorbidity index (HCT-CI) score was 0-3;\n* (8) expected survival time of at least 12 weeks;\n* (9) women who are not pregnant or breastfeeding;\n* (10) voluntary participation in clinical research; They or their legal guardians were fully aware of the study and signed informed consent. Willing to follow and complete all trial procedures;\n\nExclusion Criteria:\n\n* (1) pregnant or lactating women;\n* (2) other serious conditions that may limit enrollment (e.g., advanced infection, etc.);\n* (3) unable to understand and follow the study protocol or sign the informed consent form.",{"count":493,"type":20},22,[23],"The aim of this study is to evaluate the efficacy and safety of anti-thymocyte globulin combined with PTCy (post-HSCT cyclophosphamide, PTCy) in preventing graft-versus-host disease (GVHD) in allo-HSCT patients after anti-PD-1(anti-programmed cell death protein 1) antibody treatment. In this study, patients with hematological malignancies who needed to receive allo-HSCT after PD-1 antibody treatment were selected as the research subjects. Fludarabine and Busulfan was used as the conditioning regimen, and the dose of ATG (anti-thymocyte globulin, ATG) combined with PTCy was used as the GVHD prevention regimen. The aim of this study is to reduce the incidence of Regimen-Related Toxicity and GVHD without affecting engraftment and relapse, thereby reducing non-relapse mortality and further improving the survival of patients.",[497,498],"Graft-versus-host Disease","Hematological Malignancies","2024-02-19",{"date":501,"type":31},"2024-02-20",{"date":503,"type":20},"2024-02-28",{"date":505,"type":20},"2026-06-30",{"name":37,"class":38},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":15,"minAge":514,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":518,"conditions":519,"keywords":523,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":89},"100401868","comparison-of-efficacy-in-sbrt-of-large-hcc-with-or-without-tace-100401868","NCT04512846","Comparison of Efficacy in SBRT of Large HCC With or Without TACE","Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)","Inclusion Criteria:\n\n* primary HCC diagnosed by a surgeon and\u002For radiologist and oncologist according to the international guidelines for the management of HCC or by pathology\n* single lesion and longest tumor diameter were 5-10cm;\n* CP-A or B classification;\n* Eastern Cooperative Oncology Group (ECOG) score 0-1;\n* distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm\n* unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.\n* rejecting other therapies such as resection, liver transplantation, etc.\n* platelet count≥50 × 109\u002FL, white blood count≥1.5 × 109\u002FL;\n* patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.\n\nExclusion Criteria:\n\n* tumor thrombus;\n* lymph node involvement;\n* extrahepatic metastasis.","30 Years","80 Years",{"count":517,"type":20},100,"The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.",[520,521,522],"Large HCC Patients","Stereotactic Body Radiation Therapy","Transcatheter Arterial Chemoembolization",[524,525,526,527],"CyberKnife","SBRT","large HCC","prognosis","2023-06-24",{"date":530,"type":31},"2023-06-27",{"date":532,"type":31},"2020-08-01",{"date":534,"type":20},"2026-08-30",{"name":37,"class":38},{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":15,"minAge":514,"maxAge":515,"enrollmentInfo":543,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":555,"locationsCount":89},"100401867","cyberknife-stereotactic-body-radiation-therapy-for-small-hepatocellular-carcinoma-patients-with-decompensated-cirrhosis-100401867","NCT04512833","CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis","CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Primary HCC diagnosed by a surgeon and\u002For radiologist and oncologist according to the international guidelines for the management of HCC or by pathology\n* Unfeasible or refusing to undergo other treatments;\n* Residual normal liver volume ≥700 cc;\n* With decompensated cirrhosis (Child-Pugh B or C classification);\n* Without portal vein tumor thrombus;\n* Eastern Cooperative Oncology Group (ECOG) score 0-1;\n* Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm；\n* Rejecting other therapies such as resection, liver transplantation, etc.\n* Platelet count≥50 × 109\u002FL, white blood count≥1.5 × 109\u002FL;\n* Patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.\n\nExclusion Criteria:\n\n* With Tumor thrombus；\n* With extrahepatic metastasis;\n* With lymph node involvement.",{"count":392,"type":20},"The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.",[350],[547,524,548,549,550],"hepatocellular carcinoma","stereotactic body radiation therapy","Child-Pugh B classification","Child-Pugh C classification",{"date":530,"type":31},{"date":553,"type":31},"2020-08-12",{"date":534,"type":20},{"name":37,"class":38},""]