[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanxi Province Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,70,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100643237","phase-2-disitamab-vedotin-plus-intravesical-mitomycin-c-in-her2-expressing-intermediate--to-high-risk-non-muscle-invasive-bladder-cancer-100643237",false,"NCT07646145","Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer","Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntary participation, signing a written informed consent form;\n* The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender;\n* The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field;\n* The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma);\n* The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;\n* Tumor tissue samples for TURBT must be provided, along with the required relevant pathological reports. Fresh surgical tissues or pathological slides can be sent for examination as well;\n* The patients were intolerant to BCG or did not accept the BCG infusion treatment plan;\n* Before treatment, HER2 detection was conducted on the resection specimens in the laboratory: The IHC results confirmed HER2 expression (defined as: IHC 1+, 2+ or 3+);\n* Clinical non-metastatic bladder cancer (N0, M0) was determined by abdominal computed tomography (CT).\n\nExclusion Criteria:\n\n* History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;\n* Imaging results within 3 months before treatment indicated lymph node or other site\u002Forgan metastasis;\n* Imaging results within 3 months before treatment indicated the presence of other urinary system tumors;\n* Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and\u002For investigational drug therapy;\n* Received bladder radiotherapy for urothelial carcinoma before treatment;\n* Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs;\n* Within the 3 days prior to the first infusion, the following conditions had not yet been alleviated to CTCAE grade 1:Uncontrolled acute or chronic infections, such as pneumonia, biliary tract infections;Hepatitis B and Hepatitis C infections; dyspnea;Acute or chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction;\n* NYHA rating of 3 or 4;\n* Symptoms and signs related to cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc.;\n* Known cerebrovascular accidents;\n* History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, etc.);\n* Known positive HIV serology, Hepatitis C infection and\u002For Hepatitis B (HepBsAg or core antibody positive and responding after antiviral treatment for Hepatitis B, except for these patients: these patients are allowed to participate in this study; Note: Patients with negative HepBsAg at screening)","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.",[26],"Non-Muscle-Invasive Bladder Cancer (NMIBC)","RECRUITING","2026-06-09",{"date":30,"type":31},"2026-06-12","ACTUAL",{"date":33,"type":31},"2024-04-01",{"date":35,"type":20},"2027-04",{"name":37,"class":38},"Shanxi Province Cancer Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100630359","phase-1-osimertinib-plus-capivasertib-in-nsclc-with-pik3caakt1pten-alterations-following-prior-1l-osimertinib-100630359","NCT07486648","Osimertinib Plus Capivasertib in NSCLC With PIK3CA\u002FAKT1\u002FPTEN Alterations Following Prior 1L Osimertinib","The Safety and Efficacy of Osimertinib Plus Capivasertib in EGFRm Advanced Non-small Cell Lung Cancer (NSCLC) Participants With PIK3CA\u002FAKT1\u002FPTEN Alterations Who Had Progressed on First-line Osimertinib Monotherapy or Plus Chemotherapy: a First-in-human, Phase Ib\u002FⅡa Study (PRECISION)","Precision","Inclusion criteria\n\nInformed consent\n\n1. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses\n\n   Age\n2. Male or female age ≥18 years at the time of signing the ICF.\n\n   Type of participant and disease characteristics\n3. Histologically or cytologically confirmed non-squamous locally advanced or metastatic NSCLC which is not amenable to curative therapy.\n4. Documented EGFR sensitive mutations (exon19 deletion, L858R mutation) prior to the first-line EGFR-TKI therapy.\n5. Documented radiologic progression on first-line treatment with Osimertinib monotherapy or Osimertinib plus chemotherapy:\n\n   * Participants treated with Osimertinib in the adjuvant setting can be included if progression occurred \\\u003C 6 months after last dose.\n   * Participants must be immunotherapy (i.e., programmed cell death protein 1 \\[PD-1\\] inhibitor, programmed cell death protein 1 ligand 1 \\[PD-L1\\] inhibitor, Cytotoxic T-lymphocyte associated protein 4 inhibitor) naïve in the metastatic setting.\n   * Prior immunotherapy in the neoadjuvant or adjuvant setting is acceptable providing treatment was completed more than 6 months before metastatic\u002Frecurrent disease was diagnosed.\n6. Mandatory provision of the required number of FFPE tumour tissue samples for PIK3CA mutations and\u002For AKT1 mutations and\u002For PTEN loss-of-function (LOF) mutations testing, which fulfils the following requirements:\n\n   * Obtained following progression on previous Osimertinib monotherapy or Osimertinib plus chemotherapy as first-line treatment.\n   * Specimen to meet the requirements defined in the Central Laboratory Manual and Diagnostic Testing Manual.\n   * Have PIK3CA and\u002For AKT1 and\u002For PTEN alterations as determined by NGS testing by a sponsor designated central laboratory on tumour specimen collected following progression on prior Osimertinib treatment.\n7. At least one lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with CT or MRI, which is suitable for accurate repeated measurements. If only one measurable lesion exists, it is acceptable to be used if baseline tumour assessment scans are done at least 14 days after the screening tumour specimen collection is performed.\n8. Adequate bone marrow reserve and organ function as follows:\n\n   * Absolute neutrophils count (ANC) ≥1.5x109\u002FL.\n   * Platelets count ≥100x109\u002FL.\n   * Haemoglobin (Hb) ≥90g\u002FL.\n   * Total bilirubin ≤1.5 times upper limit of normal (ULN) or ≤3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases.\n   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5ULN (or ≤5 ULN in the presence of liver metastases).\n   * Serum Creatinine ≤1.5 ULN or creatinine clearance (CCr) ≥50mL\u002Fmin (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n10. Patients with hepatitis B virus (HBV) are only eligible for inclusion if they meet all the following criteria:\n\n    * Demonstrated absence of hepatitis C virus (HCV) co-infection or history of HCV co-infection\n    * Demonstrated absence of human immunodeficiency virus (HIV) infection\n    * Participants with active HBV infection are eligible if they are:\n    * Receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to \\\u003C100 IU\u002FmL and transaminase levels are below ULN.\n    * Participants with a resolved or chronic HBV infection are eligible if they are:\n    * Negative for HBsAg and positive for hepatitis B core antibody \\[anti-HBc IgG or total anti-HBc Ab\\]. In addition, patients should be referred to a local hepatologist and treated as per local guidelines.\n\n    or\n\n    • Positive for HBsAg, but for \\> 6 months have had transaminases levels below ULN and HBV DNA levels below \\\u003C100 IU\u002FmL or below the detectable limit of locally available test kit (i.e., are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment.\n\n    Patients with HIV are only eligible for inclusion if they meet all the following criteria:\n    * Demonstrated absence of HBV\u002F HCV co-infection\n    * Undetectable viral RNA load for 6 months\n    * CD4+ count of \\>350 cells\u002FµL\n    * No history of AIDS-defining opportunistic infection within the past 12 months\n\n    Stable for at least 4 weeks on the same anti-HIV medications.\n11. Ability to swallow and retain oral medications.\n12. Willingness and ability to comply with study and follow-up procedures. Reproduction\n13. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n\n    * Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\n    * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.\n    * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n\n    Further information in Appendix C (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods).\n14. Male participants must be willing to use barrier contraception. Exclusion criteria\n\nMedical conditions\n\n1. Patients harbouring concurrent actionable driver mutations with locally approved targeted therapies (e.g., MET amplification) will be excluded.\n2. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n3. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n   * Fasting glucose ≥7.0 mmol\u002FL (126 mg\u002FdL) or 2 hours after glucose solution intake, blood glucose ≥11.1 mmol\u002FL (200 mg\u002FdL).\n   * HbA1c ≥8.0% (63.9 mmol\u002Fmol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.\n4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection (e.g. patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B virus (HBV) infection, or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) .\n\n   • Screening for chronic conditions is not required.\n5. Spinal cord compression, leptomeningeal metastasis, or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n6. Any of the following cardiac criteria:\n\n   * Mean resting corrected QTc \\>470 msec, obtained from triplicate electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value.\n   * History of QT prolongation associated with other medications that required discontinuation of that medication.\n   * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block and second-degree heart block.\n   * Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.\n   * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including:\n\n     * Hypokalaemia\\|\\* ≥ CTCAE Grade 2.\n     * Heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.\n     * Correction of electrolyte abnormalities should be documented prior to first dose.\n   * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) Grade 2.\n7. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.\n8. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment except for alopecia and grade 2 prior platinum-therapy related neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the Investigator may be included (e.g., hearing loss).\n9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of IP.\n10. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n\n    Prior\u002Fconcomitant therapy\n11. Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.\n12. Prior or current treatment with any PI3K\u002FAKT pathway inhibitors, including but not limited to: Capivasertib or other AKT inhibitors, PI3K inhibitors, or agents targeting key nodes in this pathway (e.g., PTEN-modulating therapies).\n13. Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.\n14. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study intervention or has not recovered from side effects of such therapy.\n15. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study. Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery (VATS) are permitted.\n16. Systemic therapy: Prior exposure to any anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as luteinizing hormone releasing hormone \\[LHRH\\] agonists) without appropriate washout period before enrolment, for example, enrolment within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents.\n17. Participants currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers (at least 3-week prior), moderate inducers (at least 2-week prior) or strong inhibitors of CYP3A4 (at least 2-week prior). All participants must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer or inhibitor effects on CYP3A4. Any concomitant medication that may interfere with Osimertinib safety and efficacy based on the prescribing information of Osimertinib and local clinical guidelines.\n\n    Prior\u002Fconcurrent clinical study experience\n18. Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n    Other exclusions\n19. History of hypersensitivity to active or inactive excipients of Capivasertib or Osimertinib or drugs with a similar chemical structure or class.\n20. Women who are currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant.\n21. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).",{"count":49,"type":20},53,[51,23],"PHASE1","The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA\u002FAKT1\u002FPTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy).\n\nThe main questions it aims to answer are:\n\nPart A:\n\n* Number of Dose-limiting toxicities (DLTs)\n* Adverse events (AEs)\u002Fserious adverse events (SAEs) (graded by CTCAE Version 5.0)\n* Recommended combined dose (RCD)\n\nPart B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria.\n\nParticipants will:\n\nPart A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period.\n\nPart B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on \u002F3 days off) till disease progression (PD) or unacceptable toxicity.",[54,55,56],"Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Advanced Non-small-cell Lung Cancer",[58,59],"NSCLC","Osimertinib plus Capivasertib","NOT_YET_RECRUITING","2026-03-23",{"date":63,"type":31},"2026-03-24",{"date":65,"type":20},"2026-05-15",{"date":67,"type":20},"2028-12-31",{"name":37,"class":38},2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":39},"100565040","phase-2-phase-ii-clinical-trial-of-chidamide-combined-with-ak112-for-second-line-and-advanced-bone-and-soft-tissue-sarcoma-100565040","NCT06637007","Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma","Single Arm, Open Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma","Inclusion Criteria:\n\n* The patient voluntarily participated in this study and signed an informed consent form；\n* All advanced bone and soft tissue sarcomas diagnosed by pathology have at least one measurable lesion according to RECIST 1.1 criteria, mainly including synovial sarcoma, smooth muscle sarcoma, vascular sarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, protuberant skin fibrosarcoma, Ewing's sarcoma\u002Fprimary neuroectodermal tumor, connective tissue proliferative small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroadenoma, chondrosarcoma, osteosarcoma. Except for the following types: malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra bone mucinous chondrosarcoma;\n* Patients with advanced bone and soft tissue sarcoma who experience disease progression or failure after first-line standard treatment;\n* 18\\~75 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;\n* Adequate organ and bone marrow function, no severe hematopoietic dysfunction, heart, lung, liver, kidney, thyroid dysfunction, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other related medical support received within 14 days prior to the use of the study drug)；\n* The main organ function meets the following criteria within 7 days before treatment:\n\n  1. Blood routine examination standard (without blood transfusion within 14 days)：\n\n     * hemoglobin（HB）≥90g\u002FL；\n\n       * Absolute Neutrophil Count（ANC）≥1.5×109\u002FL；\n\n         * platelet（PLT）≥80×109\u002FL。\n  2. Biochemical tests must meet the following standards：\n\n     * total bilirubin（TBIL）≤1.5 upper limit of normal (ULN) ；\n\n       * Alanineaminotransferase（ALT）and Aspartic transaminaseAST≤2.5 ULN，If accompanied by liver metastasis, ALT and AST≤5 ULN；\n\n         * Serum creatinine（SCr）≤1.5 ULN or Creatinine clearance rate(CCr)≥60ml\u002Fmin；\n  3. Doppler ultrasound evaluation：Left ventricular ejection fraction (LVEF) ≥ Low limit of normal (50%)。\n* Thyroid Stimulating Hormone（TSH）or Free Thyroxine（FT4）or Free triiodothyronine（FT3）all within the normal range of ± 10%.\n* Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; Serum or urine pregnancy test negative within 7 days prior to enrollment in the study, and must be non lactating.\n* patient; Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.\n\nExclusion criteria: Patients with any of the following conditions will not be included in this study\n\n* Patients who have previously used sildenafil or other histone deacetylase inhibitors;\n* Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);\n* Other malignant tumors that have occurred or are currently present within the past 5 years, except for cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\\];\n* Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and biological therapy (such as tumor vaccines, cytokines, or growth factors that control cancer), within 28 days before starting the research treatment;\n* Have received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 7 days before starting the research treatment;\n* Planned systemic anti-tumor therapy within 4 weeks prior to enrollment or during the study medication period, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin C within 6 weeks prior to receiving experimental drug treatment). Expanded field radiation therapy (EF-RT) was performed within 4 weeks prior to enrollment, or limited field radiation therapy was performed within 2 weeks prior to grouping to assess tumor lesions;\n* Accompanied by pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE grade 2 respiratory distress \\[grade 2 respiratory distress refers to shortness of breath during light activity; affects instrumental daily activities\\]);\n* Unrelieved toxic reactions above CTC AE (4.01) grade 1 caused by any previous treatment, excluding hair loss;\n* Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;\n* Patients with any severe and\u002For uncontrolled illnesses, including:\n\n  1. Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);\n  2. Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC ≥ 480ms), and grade ≥ 2 congestive heart failure (NYHA classification);\n  3. Active or uncontrolled severe infections (≥ CTC AE level 2 infection);\n  4. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;\n  5. Renal failure requires hemodialysis or peritoneal dialysis;\n  6. Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n  7. Poor control of diabetes (FBG\\>10mmol\u002FL);\n  8. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\\>1.0 g;\n  9. Patients with epileptic seizures who require treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment;\n* Patients with any signs or medical history of bleeding, regardless of the severity; Patients who have experienced any bleeding or bleeding events ≥ CTCAE grade 3 within the first 4 weeks of enrollment, with unhealed wounds, ulcers, or fractures;\n* Individuals who have experienced arterial\u002Fvenous thrombotic events within the past 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;\n* Patients with active ulcers, intestinal perforation, and intestinal obstruction;\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n* Participated in clinical trials of other anti-tumor drugs within 28 days prior to enrollment;\n* According to the researchers' judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.","75 Years",{"count":19,"type":20},[23],"Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.",[82,83,84],"Sarcoma,Soft Tissue","Sarcoma","Sarcoma of Bone","2024-10-10",{"date":87,"type":31},"2024-10-15",{"date":89,"type":31},"2024-08-01",{"date":91,"type":20},"2024-12-31",{"name":37,"class":38},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":39},"100535736","phase-2-a-single-arm-single-center-open-label-phase-ii-study-of-zanubrutinib-combined-with-r-chopr-dhap-in-newly-diagnosed-mantle-celllymphoma-patients-100535736","NCT06255704","A Single-arm, Single-center, Open-label Phase II Study of Zanubrutinib Combined With R-CHOP\u002FR-DHAP in Newly Diagnosed Mantle CellLymphoma Patients","A Single-arm, Single-center, Open-label Phase II Study of Zanubrutnib Combined With R-CHOP\u002FR-DHAP Alternating Regimen for First-line MCL and Followed by Zanubrutinib Rituximab Maintenance Therapy","Z+RCHOP\u002FRDHAP","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of MCL according to WHO classification;\n* Previously untreated MCL.\n* Age ≥ 18 and ≤ 70 years old.\n* ECOG, 0\\~2.\n* Suitable for high-dose treatment including high-dose Ara-C.\n* Stage II-IV (Ann Arbor).\n* Measurable disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI). Measurable disease was defined as at least 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions; in case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations.\n* The following laboratory tests during the screening period (unless related to MCL disease)\n* 1\\) Neutrophils ≥1×109\u002FL within 7 days prior to study entry, and no growth factor support therapy.\n* 2\\) Platelets ≥75×109\u002FL within 7 days prior to study entry without growth factor support or blood transfusion.\n* 3\\) Hemoglobin ≥75g\u002FL shall not be transfused within 7 days before the test. If bone marrow is involved, neutrophils ≥0.75×109\u002FL, platelets ≥50×109\u002FL, hemoglobin ≥50g\u002FL)\n* 4\\) Creatinine clearance ≥30ml\u002Fmin\n* 5\\) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN).\n* International Standardized ratio (INR) ≤1.5 and activated partial prothrombin kinase time (APTT) ≤1.5×ULN. If there is a clotting factor inhibitor that causes an elevated INR or prolonged APTT, it is up to the investigator to decide whether to enroll the patient.\n* Sexually active men and women of child-bearing potential must agree to use highly effective contraceptives (eg, condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug\n* Life expectancy \\> 3 months.\n* Written informed consent form according to GCP and national regulations.\n\nExclusion Criteria:\n\n* Known CNS involvement of MCL, Leukemic non-lymphonodular mantle cell lymphoma was excluded.\n* Major surgery within 4 weeks of screening\n* Concomitant or previous malignancies within the last 2 years other than basal cell skin cancer or in situ uterine cervix cancer\n* Clinically significant cardiovascular disease such as uncontrolled arrhythmias and hypertension , congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below 50%（AHA，2016）\n* QTcF \\> 450 msec or other significant electrocardiogram (ECG) abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block\n* Clinically significant hypersensitivity (eg, anaphylactic or anaphylactoid reactions to the compound of zanubrutinib itself or to the excipients in its formulation)\n* Requires treatment with strong CYP3A inhibitors or strong CYP3A inducers\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Active infection including infections requiring oral or intravenous antimicrobial therapy\n* Patients with unresolved hepatitis B or C infection or known HIV positive infection\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Pregnancy or lactation\n* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could have compromised the patient's safety, or put the study at risk\n* Participation in another clinical trial within 30 days before enrollment in this study\n* poor compliance","70 Years",{"count":103,"type":20},23,[23],"Evaluation the efficacy and safety of Zanubrutinib + R-CHOP\u002FR-DHAP for the treatment mantle cell lymphoma.",[107],"Mantle Cell Lymphoma","2024-02-12",{"date":110,"type":31},"2024-02-13",{"date":112,"type":20},"2024-03-15",{"date":114,"type":20},"2027-12-01",{"name":37,"class":38},""]