[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"maintenance-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:maintenance-therapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,69,97,128,150,178,204,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100537378","phase-3-maintenance-therapy-with-toripalimab-and-capecitabine-versus-capecitabine-alone-in-high-risk-nasopharyngeal-carcinoma-100537378",false,"NCT06277050","Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma","Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)","Inclusion Criteria:\n\n1. Pathologically confirmed nasopharyngeal carcinoma;\n2. High-risk nasopharyngeal cancer meets one of three points: a. TanyN3M0; b. High-grade rENE, coalescent nodal or invasion of surrounding structures (muscle, skin, nerves, etc.); c. Detectable EBV DNA after 2 cycles of induction chemotherapy.\n\n3.18-70 years old, both genders; 4. ECOG≤1; 5. Received 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy (intensity-modulated radiotherapy); 6. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet count ≥ 75×109\u002FL; Hemoglobin ≥ 9 g\u002FdL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml\u002Fmin (Cockcroft-Gault formula); serum albumin ≥28 g\u002FL.\n\n7\\. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative; 8. Written informed consent;\n\nExclusion Criteria:\n\n1. Recurrent or distant metastatic nasopharyngeal carcinoma.\n2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.\n3. Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC\n4. Has received prior therapy with an anti-PD-1 mab.\n5. Active autoimmune diseases or history of autoimmune diseases that may relapse.\n\n   Note: Patients with the following diseases are not excluded and may proceed to further screening:\n   1. Controlled Type I diabetes\n   2. Hypothyroidism (provided it is managed with hormone replacement therapy only)\n   3. Controlled celiac disease\n   4. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of external triggering factors.\n6. Any condition that required systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the start of the study。\n\n   Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:\n   1. Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)\n   2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\n   3. Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)。\n7. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.\n8. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.\n\n   1. Severe infections within 4 weeks before the start of the study, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n   2. Received therapeutic oral or intravenous antibiotics within 2 weeks before start of the study.\n9. A known history of HIV infection\n10. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is \\>1000 IU\u002FmL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C1000 IU\u002FmL), and cured hepatitis C patients can be enrolled.\n11. Any major surgical procedure requiring general anaesthesia ≤28 days before start of study。\n12. Prior allogeneic stem cell transplantation or organ transplantation.\n13. Any of the following cardiovascular risk factors:\n\n    1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before start of study\n    2. Pulmonary embolism ≤28 days before start of study\n    3. Any history of acute myocardial infarction ≤6 months before start of study\n    4. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before start of study\n    5. Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start of study\n    6. Any history of cerebrovascular accident ≤6 months before start of study\n    7. Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications ≤28 days before start of study\n    8. Any episode of syncope or seizure ≤28 days before start of study.\n14. A history of severe hypersensitivity reactions to toripalimab, capecitabine and\u002For any of its excipients.\n15. Has received any herbal medicine used to control cancer within 14 days of the start of study\n16. Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)\n17. Concurrent participation in another therapeutic clinical study\n18. Emotional disturbance or mental illness\n19. Refusal or inability to sign informed consent","ALL","18 Years","70 Years",{"count":20,"type":21},264,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.\n\nThe purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).",[27,28,29],"Nasopharyngeal Carcinoma","High-Risk Cancer","Maintenance Therapy","RECRUITING","2026-05-13",{"date":33,"type":34},"2026-05-15","ACTUAL",{"date":36,"type":34},"2024-03-07",{"date":38,"type":21},"2031-02-20",{"name":40,"class":41},"Jiangxi Provincial Cancer Hospital","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100635311","phase-1-efficacy-and-safety-of-autologous-peptide-induced-active-immunity-in-aml-maintenance-therapy-100635311","NCT07551037","Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy","A Randomized, Controlled, Prospective Study on the Efficacy and Safety of Active Immunity Induced by Autologous Peptides for Maintenance Therapy in Acute Myeloid Leukemia (AML)","AML","Inclusion Criteria:\n\n* Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy.\n* Aged 18 to 70 years.\n* Receiving a maintenance therapy regimen without hormonal agents.\n* Leukocyte and lymphocyte counts have basically returned to the normal range.\n* Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission.\n* Patients who voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria：\n\n* Patients who still require hormonal maintenance therapy after achieving remission.\n* Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors.\n* Having participated in other clinical trials within 1 month prior to screening.\n* Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions.\n* Having other uncontrolled diseases that the investigator deems unfit for enrollment.\n* Patients with psychiatric disorders or those known\u002Fsuspected to be unable to fully comply with the study protocol.\n* Pregnant or lactating women.\n* HIV-infected individuals.\n* Other conditions that the investigator deems may prevent the subject from completing the study or pose a significant safety risk to the subject.\n\nWithdrawal Criteria：\n\n* Judged by the investigator to be in the best interest of the subject.\n* Disease progression or initiation of other anti-leukemia therapy.\n* The subject requests to withdraw from the study for any reason at any time.\n* Lost to follow-up.\n* Death.\n* Occurrence of severe chemotherapy-induced toxic reactions, or chemotherapy delay of more than 4 weeks due to adverse reactions.\n* Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a decrease of \\> 10%; or QTc prolongation meeting the following criteria: ① QTc \\> 500 ms; ② QTc \\> 530 ms in patients with bundle branch block.\n* Hepatic toxicity: Persistent elevation of alanine transaminase (ALT) and\u002For aspartate transaminase (AST) to more than 2 times the upper limit of normal (ULN), with no response to hepatoprotective treatment.",{"count":52,"type":21},90,[54],"PHASE1","Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate \\\u003C40%. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves survival but is limited by donor matching and patient tolerance, resulting in a transplantation rate \\\u003C20%. Clinically, there is an urgent need for a well-tolerated, low hepatotoxic\u002Fnephrotoxic maintenance regimen effective for preventing recurrence.\n\nTumor immunotherapy is a major breakthrough, and neoantigen-based personalized vaccines are a key anti-recurrence direction due to their strong tumor specificity and ability to induce long-term immune memory. However, existing neoantigen vaccines rely on NGS sequencing and bioinformatics for epitope screening, suffering from long development cycles, high costs, proneness to missing cancer-causing mutations, and poor clinical feasibility, hindering widespread use. This study adopts a patented Sino-US innovative technology: in vitro induction of patients' own AML cells to obtain a complete set of tumor antigen peptides for personalized vaccine preparation, circumventing traditional bottlenecks to achieve \"full antigen coverage\" personalized active immunity.\n\nThis study has significant clinical and scientific value: (1) It is the first application of this patented technology in AML maintenance therapy, filling domestic and international research gaps and providing a novel treatment option; (2) Using a randomized controlled design, it compares the efficacy of immunotherapy administered during vs. after consolidation chemotherapy to identify the optimal treatment mode; (3) It screens reliable anti-leukemia immunity monitoring methods and time points, offering evidence-based support for efficacy evaluation and prognostic prediction; (4) It verifies the treatment's safety, laying a foundation for developing low-toxic, high-efficacy AML maintenance regimens, ultimately improving patients' long-term survival and advancing precision immunotherapy for AML.",[57,58,29],"Acute Myeloid Leukemia","Personalized Active Immunotherapy","2026-04-27",{"date":61,"type":34},"2026-05-01",{"date":63,"type":34},"2024-09-01",{"date":65,"type":21},"2026-09-01",{"name":67,"class":41},"Fujian Medical University Union Hospital",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":68},"100635977","a-real-world-study-on-the-efficacy-and-safety-of-menin-inhibitors-as-maintenance-after-allo-hsct-100635977","NCT07559695","A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT","A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Age ≥ 15 years.\n2. Patients diagnosed with acute leukemia (including AML, ALL, and MPAL) according to the World Health Organization (WHO 2022) criteria.\n3. Must meet one of the following characteristics: a. Harboring an NPM1 gene mutation (without concurrent FLT3-ITD or FLT3-TKD mutation); b. Harboring a KMT2A gene rearrangement or KMT2A-PTD; c. Harboring a NUP98 gene rearrangement; d. Other acute leukemia subtypes dependent on the menin-KMT2A interaction, if evidenced, may be enrolled upon discussion with and approval from the principal research team.\n4. Has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with ≥ 30 days elapsed since the date of graft infusion.\n5. Received menin inhibitor maintenance therapy after allo-HSCT and meets the following conditions: a. Received at least ≥ 2 complete cycles (7 days per cycle) of menin inhibitor therapy, or cumulative medication duration ≥ 14 days; b. Patient was in a state of CR\u002FCRh\u002FCRi at the initiation of maintenance therapy.\n6. No evidence of leukemia relapse during menin inhibitor maintenance therapy, defined as: a. Bone marrow blasts \\\u003C 5%, and blasts do not exhibit morphological features of acute leukemia (e.g.Auer rods); b. No evidence of extramedullary leukemia (e.g. CNS leukemia or myeloid sarcoma).\n7. The menin inhibitors used include but are not limited to: Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors.\n8. Capable of understanding and voluntarily signing the informed consent form.\n9. Complete clinical data.\n\nExclusion Criteria:\n\n1. Presence of any of the following at the initiation of menin inhibitor maintenance therapy (including within 28 days prior to starting treatment): a. Morphologic relapse in bone marrow (bone marrow blasts ≥ 5%); b. Presence of leukemic cells in peripheral blood.\n2. Active infection that is deemed uncontrolled by the investigator.\n3. Severe organ dysfunction, including: a. Hepatic impairment: ALT or AST ≥ 5 × ULN (Upper Limit of Normal), or total bilirubin ≥ 3 × ULN; b. Severe renal impairment: eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²; c. Cardiac dysfunction: NYHA (New York Heart Association) Class III-IV.\n4. Concurrent acute graft-versus-host disease (aGVHD) ≥ Grade 2 or chronic graft-versus-host disease (cGVHD) ≥ Grade 3, requiring corticosteroids ≥ 1 mg\u002Fkg and ≥ 3 types of immunosuppressive therapy (including CNI, ruxolitinib, belumosudil, etc.).\n5. History of other malignancies requiring ongoing treatment (except for malignancies that have undergone curative treatment or are assessed to be in complete remission and require no systemic maintenance therapy or radiotherapy).\n6. Any gastrointestinal disorder that may affect the intake or absorption of oral medications (e.g.dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal GVHD, etc).\n7. Patients deemed unsuitable for inclusion in this study by the investigator.\n8. Severely missing clinical data, precluding efficacy or safety assessment.\n9. Receipt of other maintenance therapies, including but not limited to hypomethylating agents, donor lymphocyte infusion (DLI), or other specific small-molecule targeted drugs.","15 Years",{"count":78,"type":21},20,"OBSERVATIONAL","The objective of this observational study is to evaluate the efficacy and safety of menin inhibitor maintenance therapy in patients with acute leukemia who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nEligible patients will receive menin inhibitor maintenance therapy as part of their routine clinical practice. Acceptable agents include, but are not limited to, Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors. This study imposes no additional interventions on clinical management. The specific menin inhibitor, initiation timing, dose adjustments, and treatment duration are determined at the investigator's discretion based on the patient's individual condition and clinical circumstances.\n\nPatients will enter the follow-up phase upon initiation of menin inhibitor maintenance therapy. Efficacy and safety will be assessed at every cycle during the treatment period. Following the completion of treatment, survival follow-up visits will be conducted every three cycles. The primary endpoint is 2-year relapse-free survival rate since enrollment. The secondary endpoints included overall survival, event-free survival, cumulative incidence of relapse, non relpase related mortality and safety.",[82,83,84,29,85,86,87],"Menin Inhibitors","Acute Leukemia","Post Hematopoietic Stem Cell Transplantation","KMT2A Rearrangement","NPM1 Mutation","NUP98 Gene Rearrangement","2026-04-24",{"date":90,"type":34},"2026-04-30",{"date":92,"type":34},"2025-11-01",{"date":94,"type":21},"2029-12-31",{"name":96,"class":41},"The First Affiliated Hospital of Soochow University",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":18,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":116,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100628593","phase-3-mrd-guided-maintenance-post-hct-gilteritini-vs-sorafenib-100628593","NCT07463651","MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib","Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients","TROPHY-15","Inclusion Criteria:\n\n* Informed consent and willingness to participate in this clinical study;\n\n  * Gender is not limited, age range is 14-70 years old (including threshold);\n\n    * ECOG score 0-2 points;\n\n      * Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;\n\n        * Successfully accepted allo HSCT, with no restrictions on the pre-treatment protocol, allowing any donor source \\[fully matched cell, unrelated donor (URD), incompatible unrelated donor, haploidentical relative donor or umbilical cord blood\\], allowing any graft source \\[umbilical cord blood, bone marrow (BM), peripheral blood (PB)\\]; ⑥ Patients with complete morphological remission (CR) prior to allo HSCT, and FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6);\n\n          ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500\u002Fμ L, platelet count ≥ 20000\u002Fμ L and not dependent on infusion), oral administration of investigational drugs, exclusion of overlap syndrome, complete donor chimerism (FDC) status, no activity requiring daily prednisone dose\\>0.5 mg\u002Fkg, acute GVHD;\n\n          ⑧ Clinical laboratory tests meet the following criteria: a. Serum creatinine ≤ 2.0 times the upper limit of normal value; b. Total bilirubin ≤ 2.5 mg\u002FdL (excluding Gilbert syndrome patients); c. Serum AST and\u002For ALT\\\u003C3 times the upper limit of normal values;\n\n          ⑨ Maintenance treatment should be started 60 to 90 days after transplantation;\n\n          ⑩ Female participants must meet the following criteria: have undergone menopause (at least 1 year without menstruation) or surgical sterilization (at least 1 month ago) before screening for infertility; Or have the ability to conceive but agree not to plan pregnancy during the study period and within 6 months after the last dose; Conduct pregnancy tests during the screening period; If there is heterosexual behavior, agree to continue using local standard high-efficiency contraceptive measures plus barrier method from the beginning of screening to 6 months after the last administration; Agree not to breastfeed or donate eggs during the study period and for 6 months after the last administration Male participants must meet the following requirements: male participants (even if sterilized) and their reproductive partners must use efficient contraception plus barrier method during the study period and within 127 days after the last dose; Male participants are not allowed to donate sperm during the study period and for 127 days after the last dose;\n\nExclusion Criteria:\n\n* Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;\n\n  * Any serious comorbidities that make patients unsuitable for participation in this study or may affect protocol compliance;\n\n    * FLT3-ITD molecular MRD positivity before maintenance therapy;\n\n      * Severe organ dysfunction such as organ failure occurs after allogeneic hematopoietic stem cell transplantation;\n\n        * Subjects who are positive for hepatitis B B surface antigen (HBsAg) and whose hepatitis B virus (HBV) DNA titer is higher than the upper limit of the normal value range of the research center, and who are judged by the researchers not suitable for this study; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; Individuals who are HIV antibody positive; Positive syphilis test results;\n\n          ⑥ There is evidence within the first 6 months of enrollment that the patient has other diseases or physiological conditions that may interfere with the evaluation results of this trial, or complications that seriously endanger life, including but not limited to uncontrolled infections, pulmonary arterial hypertension, severe heart failure (NYHA grades III and IV), unstable angina or acute myocardial infarction, poorly controlled refractory hypertension (based on hospitalization medical records diagnosis), etc;\n\n          ⑦ Individuals with mental or neurological disorders who are unable to express their wishes correctly;\n\n          ⑧ Individuals who have had active malignant solid tumors within the past 5 years prior to participating in this study, except for cervical cancer, localized prostate cancer in situ, and non melanoma skin cancer that have been cured;\n\n          ⑨ Have participated in or are currently participating in other clinical trials within one month prior to enrollment;\n\n          ⑩ Researchers have determined that individuals are not suitable to participate in this clinical trial.","14 Years",{"count":107,"type":21},594,[24],"The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.\n\nAll patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.\n\nStudy Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.",[111,112,113,29,114,115],"Acute Myeloid Leukemia (AML)","FLT3-ITD Mutation","Allogeneic Hematopoietic Cell Transplantation (HCT)","Gilteritinib","Sorafenib",[57,112,117,118,114,119],"Allogeneic Hematopoietic Cell Transplantatio","Maintenance therapy","sorafeni","2026-03-18",{"date":122,"type":34},"2026-03-20",{"date":61,"type":21},{"date":125,"type":21},"2030-03-31",{"name":96,"class":41},2,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":68},"100600746","phase-2-phase-2-trial-of-bn104-as-post-hsct-maintenance-in-acute-leukemia-100600746","NCT07101497","Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia","Phase 2 Trial of Menin Inhibitor BN104 as Post Hematopoietic Stem Cell Transplantation Maintenance in Patients With Acute Leukemia","Inclusion Criteria:\n\n* Male or female patients.\n* Adult and adolescent patients aged ≥12 years who must weight ≥35 kg.\n* Diagnosed with acute myeloid leuekmia, acute lymphoblastic leukemia or ambiguous acute leukemia according to the World Health Organization classification of hematologic neoplams (WHO 2022).\n* Intermediate or high risk accroding to the ELN risk stratification.\n* Harboring one of the following genetic aberrations: a. somatic NPM1 mutation (without FLT3-ITD\u002FTKD co-mutations); b. KMT2A rearrangement\u002FKMT2A-PTD; c. NUP98 rearrangement; d. other genetic alterations dependent on menin-KMT2A.\n* Received allogenic hematopoietic stem cell transplantation within 30-180 days at the initiation of BN104 maintenance therapy.\n* Achieved full donor chimerism and hematologic recovery, with acute neuthrophil count (ANC) ≥1.0×10⁹\u002FL, platelets ≥75×10⁹\u002FL (no red blood cells \u002Fplatelets transfusion within 7 days, no G-CSF or GM-CSF within 72 hours).\n* Complete hematological remission (CHR) after first allo-SCT. CHR must be confirmed by bone marrow analysis within 14 days before entering the study (CHR criteria are: \"\\\u003C 5% marrow blasts, no peripheral blasts, blood platelet count \\> 75×10⁹\u002FL, WBC count \\> 3.5 G\u002FL, ANC ≥ 1.0×10⁹\u002FL).\n* No extramedullary leukemia.\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.\n* Adequate organ function\n* Provided informed consent by all patients and the guardians ( aged 12-17 years).\n* Written informed consent.\n* ECOG ≥ 2.\n\nExclusion Criteria:\n\n* Complicated with active and uncontrolled infections.\n* Activation of virus, (e.g., CMV viremia with CMV DNA copies \\> 400 copies\u002Fml, EBV viremia with EBV DNA copies \\> 400 copies\u002Fml, and proof of activation of adenovirus and Human Parvovirus B19 ).\n* Activation of hepatitis B, hepatitis C, or human immunodeficiency virus.\n* Cardiac disease as followings: a. inherited long QT syndrome. b. Congestive heart failure with NYHA ≥ grade 2.\n* ≥ grade 2 acute GVHD or ≥ grade 3 chronic GVHD which requiring systemic therapy.\n* Have received other maintenance therapies (e.g., hypomethylating agents, targetd drugs such as Bcl-2 inhibitors, FLT3 inhibitors, IDH1\u002F2 inhibitors, interferon, interleukin-2, donor lymphocyte infusion and chemotherapy).\n* History of other malignancies which needed systemic treatment (excluding those in stable remission without maintenance therapy).\n* Any gastrointestinal condition that may interfere with oral drug intake or absorption (e.g., dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal graft versus host disease.\n* Pregnancy, breastfeeding\n* Hypersensitivity to BN104.","12 Years",{"count":137,"type":21},60,[139],"PHASE2","This is a phase 2, open label, single arm trial. This study aims to assess the efficacy and safety of menin inhibitor BN104 as maintenance therapy in patients with acute leukemia harboring specific genetic alterations who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nEligible patients will be screened at 30-180 days post allo-HSCT. Participants will take BN104 100-200mg orally, twice a day, 28 days a cycle for 24-36 cycles. The primary endpoint is 2-year relapse-free survival rate since enrollment. The secondary endpoints included overall survival, event-free survival, cumulative incidence of relapse, non relpase related mortality and safety.",[82,84,29,83,85,86,87],"2025-07-28",{"date":144,"type":34},"2025-08-03",{"date":146,"type":21},"2025-08-01",{"date":148,"type":21},"2029-12-30",{"name":96,"class":41},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":68},"100575979","phase-4-maintenance-chemotherapy-with-s-1-vs-observation-after-adjuvant-therapy-for-resected-pancreatic-cancer-with-high-risk-of-recurrencemetastasis-100575979","NCT06779318","Maintenance Chemotherapy With S-1 vs. Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence\u002FMetastasis","A Real-World Study Comparing Maintenance Chemotherapy With Tegafur, Gimeracil, and Oteracil Potassium (S-1) Versus Follow-Up Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence\u002FMetastasis (MSPAC-1)","Inclusion Criteria:\n\n1. Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);\n2. Meets one of the following conditions: Pathologically confirmed as moderately differentiated, moderately to poorly differentiated, or poorly differentiated; or pathologic staging as: T3N0M0, T1-3N1-2M0, T4N0-2M0; or one or more surgical margins are R1 resected (R0 resection if no tumor cells are found more than 1mm from the margin, otherwise R1 resection); or involvement of the portal vein and\u002For superior mesenteric vein resection; or pre-adjuvant chemotherapy CA19-9 \\> 90 U\u002FmL; or pre-adjuvant chemotherapy ctDNA testing positive;\n3. Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);\n4. Eligible for oral medication;\n5. Age ≥18 and ≤75, male or female;\n6. ECOG performance status: 0 to 2;\n7. Normal function of major organs as per the following criteria within 14 days prior to starting treatment:① Neutrophil count ≥ 1.5×10\\^9\u002FL;② Platelet count ≥ 75×10\\^9\u002FL;③ Hemoglobin ≥ 9.0 g\u002FdL;④ AST ≤ 2.5×UNL (upper normal limit) (if liver metastasis present, AST ≤ 5×UNL);⑤ ALT ≤ 2.5×UNL (if liver metastasis present, ALT ≤ 5×UNL);⑥ Total bilirubin ≤ 1.5×UNL;⑦ Creatinine clearance (calculated using the Cockcroft-Gault formula) \\> 60 mL\u002Fmin or serum creatinine ≤ 1.5×UNL;\n8. Women of childbearing potential must have used reliable contraception within 7 days prior to enrollment and have a negative pregnancy test, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of the investigational drug. For men, they must be surgically sterile or agree to use appropriate contraception during the study and for 3 months after treatment;\n9. Expected survival time ≥6 months;\n10. Voluntary participation in the study, signed informed consent, and demonstrated good compliance and cooperation during follow-up.\n\nExclusion Criteria:\n\n1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;\n2. Incomplete macroscopic resection (R2 resection);\n3. Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;\n4. CA19-9 \\> 180 U\u002FmL within 21 days before enrollment;\n5. Severe liver dysfunction (AST\u002FALT \\> 3.5 times the upper limit of normal, alkaline phosphatase \\> 6 times the upper limit of normal), with liver drainage;\n6. Known peripheral neuropathy (CTCAE ≥ Grade 2);\n7. Participation in another clinical trial of cytotoxic drugs, targeted therapies, immunotherapies, etc., within the past 4 weeks, or received systemic chemotherapy, radiotherapy, or biological therapy within the past 4 weeks;\n8. Concurrent or metachronous cancers with disease-free survival ≥ 5 years (excluding pancreatic cancer), except for cancers that have been cured or can be potentially cured with local excision (e.g., esophageal cancer, gastric cancer, colorectal cancer, cervical cancer, non-melanoma skin cancer, bladder cancer);\n9. Factors that significantly affect oral drug absorption, such as difficulty swallowing, chronic diarrhea, or gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;\n10. Clinically symptomatic serous effusions (including pleural effusion, ascites, pericardial effusion) requiring symptomatic treatment;\n11. Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to take effective contraceptive measures;\n12. Known allergy to the investigational drug, the class of the investigational drug, or its components;\n13. Need for systemic corticosteroid treatment (except for local steroid pre-treatment);\n14. History of interstitial lung disease (including interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;\n15. Active local or systemic infection requiring treatment;\n16. Heart failure NYHA classification ≥ II or severe heart disease;\n17. Known HIV infection or history of acquired immunodeficiency syndrome (AIDS) or active hepatitis B or C;\n18. Toxicity not recovered (CTCAE \\> Grade 1) or previous anticancer surgery not fully recovered;\n19. Patients deemed unsuitable for this study by the investigator.","75 Years",{"count":159,"type":21},464,[161],"PHASE4","The goal of this real-world study is to learn if maintenance chemotherapy with Tegafur, Gimeracil, and Oteracil Potassium (S-1) can improve disease-free survival (DFS) compared to follow-up observation in patients with resected pancreatic cancer at high risk of recurrence or metastasis after adjuvant therapy. The main questions it aims to answer are:\n\n* Does maintenance therapy with S-1 improve disease-free survival (DFS) compared to follow-up observation after standard treatment for resected high-risk pancreatic cancer?\n* Does S-1 maintenance therapy improve overall survival (OS), distant disease-free survival (DDFS), and local recurrence-free survival (LRFS) compared to observation?\n* What are the safety and tolerability profiles of S-1 maintenance therapy compared to observation? Researchers will compare two groups: the S-1 maintenance therapy group and the observation-only group, to see if S-1 improves survival outcomes and safety.\n\nParticipants will:\n\n* Receive maintenance chemotherapy with S-1 based on body surface area dosing or be assigned to the observation group without drug intervention.\n* Undergo imaging evaluations every 12 weeks to monitor for disease recurrence or metastasis.\n* Report side effects and any adverse events during the study.",[164,165,29],"Pancreatic Cancer","Postoperative Adjuvant Therapy",[29,167],"S-1","NOT_YET_RECRUITING","2025-04-02",{"date":171,"type":34},"2025-04-03",{"date":173,"type":21},"2025-07",{"date":175,"type":21},"2028-07",{"name":177,"class":41},"The First Affiliated Hospital with Nanjing Medical University",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":68},"100584338","phase-2-fruquintinib-combined-with-pd-1-inhibitor-as-first-line-maintenance-therapy-for-advanced-gastric-cancer-100584338","NCT06888037","Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer","A Prospective, Multicenter Clinical Study of Fruquintinib Combined With PD-1 Monoclonal Antibody as First-line Maintenance Therapy in Patients With HER-2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Voluntarily signed the informed consent and had good compliance;\n* Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;\n* Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;\n* He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;\n* Patients with disease progression\u002Frelapse occurring more than 6 months after completion of neoadjuvant\u002Fadjuvant therapy;\n* At least one measurable lesion according to RECIST version 1.1;\n* Tumor tissue\u002Fserum samples were tested as microsatellite stable (MSS) or mismatch repair intact (pMMR), HER2 negative;\n* Adequate organ functions:\n\nAbsolute neutrophil count ≥1.5×109\u002FL; Platelet ≥100×109\u002FL; Hemoglobin ≥90g\u002FL; WBC≥3×109\u002FL Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN (If liver metastasis, AST and ALT≤5 XULN)； Serum creatinine (Cr) ≤1.5XULN or serum creatinine clearance ≥50 ml\u002Fmin； Urinary protein ≤2+, or 24-hour urinary protein volume ≤2000mg; Prothrombin time (PT) and partially activated prothrombin time (APTT) ≤1.5×ULN;\n\n• Female or male patients of reproductive age must use effective contraception throughout and for 6 months after treatment.\n\nExclusion Criteria:\n\n* Participated in other drug clinical trials within 4 weeks before enrollment;\n* Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;\n* History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.\n* Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol\u002FL);\n* Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis;\n* Type 1 diabetes mellitus, hypothyroidism that can be controlled only with replacement therapy, and skin diseases (e.g., vitiligo, psoriasis) that do not require systemic treatment could be included;\n* Central nervous system (CNS) metastases that are not adequately treated, or the presence of uncontrolled or symptomatic active CNS metastases; Patients with adequately treated CNS metastases and neurologic symptoms that had returned to baseline at least 4 weeks before enrollment (with the exception of residual signs or symptoms related to CNS therapy) were eligible for enrollment; In addition, participants had to discontinue corticosteroids or to be taking a stable or tapering dose of prednisone (or equivalent doses of other corticosteroids) of 10 mg or less per day at least 4 weeks before enrollment;\n* The patients had pleural effusion and ascites that could not be controlled by puncture drainage and other treatments within 14 days before enrollment. Moderate or greater pericardial effusion with clinical symptoms;\n* A live or attenuated live vaccine was administered within 30 days before enrollment;\n* Major surgery had been performed within 28 days before enrollment or minor nonstudy-related surgery had been performed within 7 days before enrollment (with the exception of tumor biopsy and venous-access port placement);\n* Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment; Patients with gastrointestinal perforation and\u002For gastrointestinal fistula within 6 months before enrollment (except those whose symptoms disappeared after gastric cancer resection for bleeding\u002Fperforation of gastric cancer);\n* Arterial\u002Fvenous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months beforeenrollment;\n* Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral thrombosis) within 6 months before enrollment;\n* Severe, unhealed or open wounds and active ulcers or untreated fractures;\n* Had a history of immediate anaphylaxis;\n* The presence of clinically significant pulmonary fibrosis or interstitial pneumonia as judged by the investigator; Had active lung infection prior to injection and required anti-infective therapy;\n* Active infections included tuberculosis (medical history, investigator's judgment, radiological examination, and local laboratory testing), hepatitis B (hepatitis B surface antigen positive and HBV DNA above the upper limit of the study center's normal range), hepatitis C (HCV antibody positive and HVC RNA positive), HIV (HIV antibody positive), syphilis, etc;\n* Had active gastrointestinal bleeding or hemoptysis;\n* A history of alcohol or psychotropic substance abuse with no withdrawal or a history of mental disorder;\n* Known allergy to the study drug or any of its excipients; Or severe allergic reactions to other monoclonal antibodies;\n* Systemic antibiotic use for ≥ 7 days within 4 weeks before enrollment or unexplained fever \\>38.5°C during screening or before the first dose (fever due to a neoplastic cause, as judged by the investigator, was eligible);\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Unable to take oral medication;\n* The presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.",{"count":186,"type":21},55,[139],"This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.",[190,191,192,29,193,194],"Gastric Adenocarcinoma","GEJ Adenocarcinoma","First-line Therapy","Fruquintinib","PD-1","2025-03-20",{"date":197,"type":34},"2025-03-21",{"date":199,"type":21},"2025-03-31",{"date":201,"type":21},"2028-12-31",{"name":203,"class":41},"Ruijin Hospital",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":127},"100542337","phase-2-a-multicenter-prospective-phase-ii-study-of-zanubrutinib-for-maintenance-in-patients-with-mantle-cell-lymphoma-100542337","NCT06341556","A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma","Zanubrutinib for Maintenance Therapy in Patients With Mantle Cell Lymphoma Who Have Remission After First-line Immunochemotherapy- a Multicenter, Prospective, Phase II Study","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* Histologically confirmed mantle cell lymphoma (MCL);\n* Achieved complete response (CR) or partial response (PR) through first-line sufficient treatment (including immunochemotherapy with CD20 monoclonal antibody for at least 4 cycles). Frontline induction programs include but are not limited to: R-CHOP\u002FR-DHAP, R-CHOP, BR, etc. Previous autologous hematopoietic stem cell transplantation is allowed;\n* ECOG 0-2;\n* Signed informed consent form;\n* Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109\u002FL, PLT ≥ 50 × 109\u002FL, Hb ≥ 80g\u002FL; b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST\\\u003C3 x ULN, serum albumin ≥ 30 g\u002FL; c) Renal function: serum Cr\\\u003C1.5 × ULN, creatinine clearance rate ≥ 50mL\u002Fmin (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL\u002Fmin); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography; e) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT\u002FINR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.\n\nExclusion Criteria:\n\n* Individuals who are allergic to human or mouse monoclonal antibodies and have been confirmed to be allergic to Zanubrutinib capsules and\u002For their excipients;\n* Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;\n* Uncontrollable concurrent diseases (cardiovascular and cerebrovascular diseases, blood coagulation disorders, severe infectious diseases) include but are not limited to: severe acute or chronic infections requiring systemic treatment, symptomatic congestive heart failure (New York Heart Association classification III-IV) or symptomatic or poorly controlled arrhythmias Uncontrolled arterial hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg), unstable angina, active peptic ulcer, or hemorrhagic disease even after receiving standardized treatment;\n* Serious accompanying diseases that interfere with conventional treatment;\n* Has a history of active malignant tumors. Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma in situ who have received possible curative treatment and have no disease recurrence within 3 years since the start of treatment;\n* Known to have active interstitial pneumonia;\n* Known cases of alcohol or drug abuse;\n* Active chronic hepatitis B infection (defined as HBV DNA positive): If hepatitis B virus (HBV) DNA cannot be detected during screening, patients with latent or previous hepatitis B infection (defined as positive hepatitis B surface antigen or hepatitis B core total antibody) can be included in this study. The above patients must voluntarily undergo regular HBV-DNA testing and receive appropriate antiviral treatment according to regulations. For patients with positive hepatitis C virus (HCV) antibody serological test, only when polymerase chain reaction (PCR) shows negative HCV-RNA can participate in this study.\n* Patients with active HIV and syphilis infections;\n* Pregnant or lactating women;\n* live vaccine administered within 4 weeks prior to administering the investigational drug, inactivated virus vaccines such as for seasonal influenza are allowed;\n* Continuous corticosteroid treatment currently being received, with a dose greater than 30mg\u002Fday of prednisone or equivalent medication for at least 10 days of continuous treatment;\n* Suffering from active autoimmune diseases that require systematic treatment within the past 2 years (Hormone replacement therapy is not considered as a systematic treatment, such as type I diabetes, hypothyroidism patients who only need thyroid hormone replacement therapy, patients with adrenocortical or pituitary dysfunction who only need physiological dose of glucocorticoid replacement therapy can be included in the group, and patients with autoimmune diseases who do not need systematic treatment in the past 2 years can be included in the group);\n* Patients with swallowing disorders who are unable to take medication orally for a long time;\n* Individuals with mental disorders who affect compliance and are unable to obtain informed consent;\n* The researcher determined that patients are not suitable to participate in this study.",{"count":212,"type":21},52,[139],"This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy",[216,29],"Mantle Cell Lymphoma","2024-08-30",{"date":219,"type":34},"2024-09-04",{"date":221,"type":34},"2024-05-24",{"date":223,"type":21},"2028-06",{"name":225,"class":41},"Fudan University",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":68},"100513424","phase-4-efficacy-and-safety-for-telitacicept-in-the-remission-maintenance-treatment-of-anca-associated-vasculitis-ttcazarem-100513424","NCT05965284","Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)","A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis","Inclusion Criteria:\n\n1. Patients age 18 to 65 years, both genders can be included.\n2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR\u002FEULAR classification criteria of GPA or MPA.\n3. Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent).\n4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.\n\nExclusion Criteria:\n\n1. Patients with TPMT gene mutation.\n2. Patients who had been treated with either AZA but relapsed in the past.\n3. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.\n4. Patients who have planned for pregnancy in next 1.5 years.\n5. Patients with severe liver dysfunction(defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD(eGFR\\\u003C30ml\u002Fmin).\n6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;\n7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;\n8. Patients who had other autoimmune diseases.\n9. Patients with malignancy.\n10. Patients who are not eligible according to the judge of the principal investigators or site investigators.","65 Years",{"count":235,"type":21},40,[161],"This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.",[239,29],"ANCA-associated Vasculitis",[239,241,242,243],"Telitacicept","Azathioprine","Relapse rate","2023-07-20",{"date":246,"type":34},"2023-07-28",{"date":248,"type":34},"2023-03-09",{"date":250,"type":21},"2026-12-31",{"name":252,"class":41},"Chinese SLE Treatment And Research Group"]