[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"irae\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:irae":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,72],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100551568","exploring-physical-and-psychological-needs-and-quality-of-life-in-patients-with-advanced-cancer-receiving-immunotherapy-100551568",false,"NCT06461780","Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy","Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events","Inclusion Criteria:\n\n* (1) Patients diagnose cancer and are informed\n* (2) Aged ≥18 years old\n* (3) Conscious clear and able to communicate","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","1 Year","OBSERVATIONAL","During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.",[25,26,27,28,29,30,31],"Cancer","Immunotherapy","IrAE","Distress, Emotional","Care Need","Financial Toxicity","Quality of Life","RECRUITING","2026-04-24",{"date":35,"type":36},"2026-04-30","ACTUAL",{"date":38,"type":36},"2024-03-18",{"date":40,"type":20},"2028-08-01",{"name":42,"class":43},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100622285","phase-2-the-safety-and-efficacy-of-ondansetron-in-reducing-immune-checkpoint-inhibitor-related-toxicities-100622285","NCT07381634","The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities","The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age: 18 to 80 years old, both male and female are acceptable.\n2. The imaging or pathological diagnosis is hepatocellular carcinoma;\n3. It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.\n4. ECOG score: 0 to 2 points;\n5. Expected survival period ≥12 weeks;\n6. Baseline blood cell count tests and blood biochemistry must meet the following standards:\n\n   White blood cell count ≥3.0×10\\^9\u002FL; Hemoglobin ≥90 g\u002FL; The absolute neutrophil count is ≥1.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin ≤ twice ULN; Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g\u002FL;\n7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Those who have received treatment with ondansetron within 14 days;\n2. Patients with autoimmune diseases;\n3. Use of systemic glucocorticoids or other immunosuppressants within 14 days;\n4. Those who have previously discontinued ICI treatment due to irAEs;\n5. Those with severe liver dysfunction (Child-Pugh grade C);\n6. Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;\n7. Patients allergic to ondansetron;\n8. Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;\n9. The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.","80 Years",{"count":54,"type":20},134,"INTERVENTIONAL",[57],"PHASE2","This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.",[60,27],"Hepatocellular Carcinoma (HCC)","NOT_YET_RECRUITING","2026-03-09",{"date":64,"type":36},"2026-03-11",{"date":66,"type":20},"2026-03-20",{"date":68,"type":20},"2027-06-20",{"name":70,"class":71},"First Affiliated Hospital of Wenzhou Medical University","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":55,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"100616305","phase-2-golidocitinib-for-refractory-immune-related-hematologic-toxicities-of-advanced-lung-cancer-100616305","NCT07303881","Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer","A Clinical Study Evaluating the Safety and Efficacy of Golidocitinib in Patients With Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer","JACKPOT22","Inclusion Criteria:\n\n1. Able to provide a signed and dated informed consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this protocol.\n2. The subject is ≥18 years of age at the time of signing the ICF.\n3. Has not experienced disease progression in the past two weeks and has a Eastern Cooperative Oncology Group (ECOG) score of 0-2, with a predicted survival of ≥12 weeks.\n4. Pathologically or cytologically confirmed locally advanced (American Joint Committee on Cancer, AJCC 8th edition IIIB and IIIC stages) or metastatic (stage IV) non-small cell lung cancer, or extensive-stage small cell lung cancer (AJCC 8th edition TNM staging of lung cancer stage IV, or T3-4 disease caused by multiple pulmonary nodules with excessive disease spread, or tumor\u002Fnodule size too large for a tolerable radiation therapy plan).\n5. Patients confirmed by an accredited local laboratory to lack any therapeutically targeted driver gene mutations, i.e., driver gene-negative subjects.\n6. Patients experiencing grade ≥3 refractory hematologic toxicity (white blood cell count \\\u003C2.0 × 10⁹\u002FL or\u002Fand absolute neutrophil count \\\u003C1.0 × 10⁹\u002FL or\u002Fand platelet count \\\u003C50 × 10⁹\u002FL or\u002Fand hemoglobin \\\u003C8.0 g\u002FdL, specific hematologic parameters are detailed in Appendix D), during treatment with immune checkpoint inhibitors (including monotherapy or combination therapy), and the toxicity is considered to be immune-related. Refractory toxicity is defined in two main ways: ① Resistance to conventional treatment: No significant improvement in hematologic toxicity after at least 3 days of supportive care including the use of hormones (e.g., methylprednisolone ≥1 mg\u002Fkg\u002Fd), hematopoietic growth factors (e.g., G-CSF, TPO), and\u002For blood transfusions; ② Positive antinuclear antibody profile indicating anti-SSA antibodies and\u002For Ro52 antibodies, suggesting an immune-mediated mechanism.\n7. Patients with brain metastases must be asymptomatic or have been treated and have stable disease after discontinuation of steroids and anticonvulsants. Patients suspected of having brain metastases at screening should undergo brain CT\u002FMRI before study enrollment.\n8. At least one measurable lesion (as defined in RECIST 1.1): a lesion that has not undergone radiotherapy, has a long diameter ≥10 mm (short diameter ≥15 mm for lymph node lesions), and can be accurately and repeatedly measured from baseline on CT or MRI; and a measurable lesion outside the central nervous system.\n9. Adequate organ system functional reserve, summarized as follows:\n\n   * Total bilirubin ≤1.5×ULN; if Gilbert's syndrome (unconjugated hyperbilirubinemia) is present, total bilirubin should be ≤3×ULN.\n   * ALT and AST ≤2.5×ULN. For patients with documented liver metastases, AST and ALT levels ≤5×ULN.\n   * Creatinine clearance, calculated using the Cockcroft-Gault method, \\>60 ml\u002Fmin for patients treated with cisplatin and \\>45 ml\u002Fmin for patients treated with carboplatin.\n   * Urinalysis shows less than 2+ protein in urine, or 24-hour urine protein quantification \\\u003C1g.\n   * Good coagulation function, defined as International Normalized Ratio (INR) and\u002For Prothrombin Time (PT) ≤1.5 times the ULN and\u002For Activated Partial Thromboplastin Time (APTT) ≤1.5 of the upper limit of normal; if the subject is receiving anticoagulation therapy, PT is acceptable as long as it is within the range intended for use with the anticoagulant.\n   * Serum amylase ≤1.5 times the ULN and\u002For serum lipase ≤1.5 times the ULN.\n   * Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) ≥55%.\n10. Women of Childbearing Potential (WOCBP) must undergo a urine and\u002For serum pregnancy test (if the urine test cannot confirm a negative result) within 7 days prior to the first dose of the study drug, and the result must be negative; WOCBP or male subjects and their WOCBP partners should agree to use effective contraception from the signing of the ICF until 6 months after the last dose of the study drug. k. Participants should be able to understand the study protocol and voluntarily comply with the study and follow-up.\n\nExclusion Criteria:\n\na. An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n\nb. Prior to the first dose, any other form of immunosuppressive therapy other than corticosteroids (e.g., TNF-α inhibitors, mycophenolate mofetil, gamma globulin, rituximab, other JAK inhibitors, etc.) was received for hematologic toxicity.\n\nc. Spinal cord compression or meningeal metastases are present. d. Any of the following medical histories:\n\n* Currently participating in an interventional clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; any drug still in development requires a 5-half-life washout (or discussion with the research team);\n* Underwent major surgery (excluding diagnostic or biopsy, excluding vascular access) within 4 weeks prior to the first dose, or is expected to undergo major surgery during the study;\n* Received palliative radiation therapy within 2 weeks prior to the first dose;\n* Have experienced a serious arterial\u002Fvenous thrombotic event within 6 months prior to the first dose, including cerebrovascular accidents (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism;\n* Currently receiving (or unable to discontinue at least 1 week prior to the first dose) any known potent inducer or inhibitor of CYP3A, herbal supplements, or foods;\n* Have experienced a grade CTCAE \\> 1 adverse event (excluding any degree of alopecia and hematologic toxicity) due to prior treatment prior to the first dose. e. Has received a solid organ or blood system transplant (e.g., a previous allogeneic bone marrow transplant).\n\n  f. Has a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring corticosteroid therapy, or currently has active interstitial lung disease (including interstitial lung changes), or immune-mediated pneumonitis caused by immunotherapy.\n\n  g. Has been diagnosed with another malignancy within 5 years prior to the first dose, excluding clinically cured basal cell carcinoma, squamous cell carcinoma, and\u002For radically resected carcinoma in situ.\n\n  h. Has received a live vaccine, including attenuated live vaccines, excluding inactivated vaccines, within 30 days prior to the first dose.\n\n  i. Has known active tuberculosis, such as a positive tuberculin (PPD) test (induration diameter \\> 10 mm), a positive T-SPOT test, tuberculous lesions on chest X-ray\u002FCT, or other positive results found according to routine clinical screening (excluding those cured by investigator assessment after standard anti-tuberculosis treatment).\n\n  j. Subjects with pre-existing, uncontrollable severe infectious diseases must be excluded. If an infectious disease occurred within two months prior to the first dose, its control must be assessed by the research team to determine eligibility for enrollment.\n\n  k. Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) (see table below), and active COVID-19 infection (determined by the investigator to be clinically significant, with signs or symptoms). COVID-19 testing will be based on local practice.\n\n  l. Meeting any of the following cardiac criteria:\n* Congestive heart failure (CHF) classified as \\>II by the New York Heart Association (NYHA);\n* Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;\n* Any clinically significant abnormality on resting ECG, such as complete left bundle branch block, second\u002Fthird-degree atrioventricular block, or PR interval \\>250 msec;\n* Average calibrated QTcF \\>470 msec on three resting ECGs during the screening period;\n* Any factor that could increase the risk of QT interval prolongation or arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome, or a first-degree relative with long QT syndrome or a family history of unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval);\n* Ventricular arrhythmias requiring treatment;\n* An acute myocardial infarction (AMI), the onset of unstable angina, or a new onset of angina within 6 months prior to administration.\n\n  m. Hypersensitivity to the study drug or any component thereof. n. Intractable nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, intestinal obstruction, or a history of bowel resection that may prevent adequate absorption of the study drug.\n\n  o. Pregnancy or lactation. p. Known bleeding diathesis, i.e., hemophilia or von Willebrand disease. q. Investigator assessment indicating a serious or uncontrolled systemic disease (including poorly controlled hypertension and bleeding disorders) that precludes participation in the clinical study or may lead to poor adherence.",{"count":81,"type":20},16,[57],"This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.",[27,85,86],"Hematologic Disorder","Lung Cancer (Locally Advanced or Metastatic)",[88,89,90],"Immune-related hematologic toxicities","irAE","Lung cancer","2025-12-12",{"date":93,"type":36},"2025-12-26",{"date":95,"type":20},"2026-02",{"date":97,"type":20},"2028-12",{"name":99,"class":71},"The First Affiliated Hospital of Guangzhou Medical University"]