[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kit-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kit-gene-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100635990","phase-2-comparing-regorafenib-combined-with-envafolimab-to-physicians-choice-in-patients-with-metastatic-gastrointestinal-stromal-tumors-harboring-kit-exon-17-mutations-refractory-to-standard-treatment-100635990",false,"NCT07559864","Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment","A Phase II, Open-label, Multicenter, Randomized Controlled Clinical Trial Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment","Inclusion Criteria:\n\n* Aged ≥ 18 years, regardless of gender;\n* Confirmed as gastrointestinal stromal tumor by histopathological examination;\n* Having at least one measurable target lesion meeting the criteria of mRECIST v1.1 (non-lymph node lesions with a long axis ≥ 1.0 cm or a long axis ≥ the thickness of 2 slides); imaging assessment should be performed within 14 days before the first medication;\n* Disease progression or intolerance after treatment with imatinib, sunitinib, regorafenib, or ripretinib;\n* Primary or secondary KIT exon 17 mutation detected by genetic testing;\n* Sufficient organ and bone marrow function, defined as follows: Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count (PLT) ≥ 75×10⁹\u002FL; hemoglobin (HGB) ≥ 9.0 g\u002FdL. No use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion, or platelet transfusion within 14 days before the examination; Liver and kidney function: For subjects without liver metastasis, serum total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. For subjects with liver metastasis: TBIL ≤ 1.5×ULN; ALT and AST ≤ 5×ULN. Renal function: Serum creatinine (Scr) ≤ 1.5×ULN; Sufficient coagulation function, defined as international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5×ULN; if the subject is receiving anticoagulant therapy, it is acceptable as long as PT is within the range specified for the anticoagulant drug;\n* Provide 15 paraffin-embedded tissue sections before enrollment for immune microenvironment detection;\n* ECOG PS score of 0-2;\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* A history of intolerance to regorafenib treatment, or previous receipt of immune checkpoint inhibitor therapy;\n* Being in pregnancy or lactation;\n* Those with an expected survival period of less than 3 months;\n* Those who have undergone major surgery or suffered significant trauma within 4 weeks before the first blood collection during the screening period, or are expected to require major surgery during the study period;\n* Patients with current active ulcers or gastrointestinal bleeding;\n* A history of interstitial lung disease or non-infectious pneumonia; a history of active tuberculosis;\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* Patients with clinically confirmed autoimmune diseases; those with positive HIV or HCV; those with HBV-DNA exceeding the laboratory normal range; those with acute CMV infection;\n* Patients with clinically confirmed central nervous system metastases;\n* Patients with other malignant tumors within 5 years;\n* Immunosuppressed subjects, including those with known immunodeficiency; those currently receiving systemic steroid medications (except those who have used inhaled steroids recently or currently);\n* Uncontrolled hypertension: After active antihypertensive treatment, three consecutive blood pressure measurements indicate systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg;\n* Subjects who, in the investigator's assessment, are unable or unwilling to comply with the requirements of the study protocol.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Gastrointestinal stromal tumors (GISTs) are mostly driven by c-kit or PDGFRA mutations, and commonly occur in the stomach and small intestine. Targeted therapy is the mainstay for advanced metastatic GISTs, but there is a lack of effective regimens after drug resistance. Immune checkpoint inhibitors (ICIs) have limited efficacy as monotherapy, while tyrosine kinase inhibitor (TKI) drugs such as regorafenib can improve the immune microenvironment and exert a synergistic effect when combined with ICIs, with more significant efficacy especially in cases with kit exon 17 mutations. This study aims to explore the effectiveness of regorafenib combined with envafolimab in metastatic gastrointestinal stromal tumors with kit exon 17 mutations that have failed standard treatment.",[26,27],"GIST - Gastrointestinal Stromal Tumor","KIT Gene Mutation",[29,30,31],"Gastrointestinal Stromal Tumor","Treatment","kit gene","RECRUITING","2026-04-27",{"date":35,"type":36},"2026-04-30","ACTUAL",{"date":38,"type":36},"2025-07-14",{"date":40,"type":20},"2027-06-01",{"name":42,"class":43},"Jian Li","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100595101","phase-1-a-new-treatment-of-newly-diagnosed-kit-mutation-cbf-acute-myeloid-leukemia-100595101","NCT07028073","A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia","Avapritinib Combined With Standard Therapy for the Treatment of Newly Diagnosed KIT Mutation Acute Myeloid Leukemia With t(8;21)(q22;q22.1); Inv(16)(p13.1q22) or t(16;16)(p13.1;q22): a Prospective, Multi-center, Single-arm, Two-cohorts Study","Inclusion Criteria:\n\n* Age ≥18 years, both genders\n* Diagnosis of acute myeloid leukemia according to WHO 2022 criteria\n* Treatment-naive patients (hydroxyurea or low-dose cytarabine \\\u003C0.5g cumulative dose allowed)\n* Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) or CBFβ::MYH11 fusion gene\n* Life expectancy \\>12 weeks Group A: ≥18 and \\\u003C65 years with ECOG 0-1; Group B: ≥65 years or ≥18 and \\\u003C65 years with comorbidities (ECOG ≥2, cardiac disease, creatinine clearance 30-50ml\u002Fmin, or mild hepatic impairment)\n* Adequate organ function: bilirubin ≤2×ULN, ALT\u002FAST ≤3×ULN (≤5×ULN if leukemic infiltration), creatinine clearance ≥30ml\u002Fmin, left ventricular ejection fraction \\>45%\n\nExclusion Criteria:\n\n* Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents\n* Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)\n* Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding\n* Active uncontrolled infection\n* Significant organ dysfunction: myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure\n* Pregnancy or breastfeeding",{"count":53,"type":20},78,[55,23],"PHASE1","The goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy. The main questions it aims to answer are:\n\nTo determine the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D) of avapritinib combined with chemotherapy by Dose-limiting toxicity (DLT).\n\nDoes this combination therapy improve the rates of minimal residual disease (MRD) negativity and long-term survival outcomes?",[58,59,27,60],"Acute Myeloid Leukemia With T(8;21)(Q22;Q22)","Acute Myeloid Leukemia With T(16;16)(P13;Q22)","Avapritinib","2025-06-11",{"date":63,"type":36},"2025-06-19",{"date":65,"type":36},"2025-05-15",{"date":67,"type":20},"2027-12-31",{"name":69,"class":43},"The First Affiliated Hospital of Soochow University"]