[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-stromal-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-stromal-tumors":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,100,127,157,180,198,216,251,271,313,333,353,374,400,424,438,481,504,527,551,575],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":77,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100210159","integrated-cancer-repository-for-cancer-research-100210159",false,"NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":21,"type":22},999999,"ESTIMATED","80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[27,28,78,79,80,81,82,83,84,85,65,86,75,76],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":90,"type":91},"2026-06-29","ACTUAL",{"date":93,"type":91},"2013-11-01",{"date":95,"type":22},"2099-12",{"name":97,"class":98},"University of Nebraska","OTHER",42,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100640091","phase-1-study-of-dcc-2618-in-patients-with-gist-after-at-least-3-prior-treatments-100640091","NCT07618377","Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments","A Phase 1 Study to Evaluate the Safety of DCC-2618 in Patients With Unresectable, Metastatic, or Recurrent Gastrointestinal Stromal Tumor (GIST) Who Are Refractory or Intolerant to at Least 3 Prior Therapies","Inclusion Criteria:\n\n1. Participants with a histologically confirmed diagnosis of GIST.\n2. Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.\n3. Participants with at least one measurable lesion per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) within 28 days prior to the first administration of the investigational product.\n4. Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n\nExclusion Criteria:\n\n1. Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.\n2. Participants with uncontrolled diabetes mellitus.\n3. Participants with a systemic infection requiring treatment.","18 Years",{"count":109,"type":22},10,"INTERVENTIONAL",[112],"PHASE1","To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies",[34],"NOT_YET_RECRUITING","2026-05-25",{"date":118,"type":91},"2026-06-01",{"date":120,"type":22},"2026-07",{"date":122,"type":22},"2028-02",{"name":124,"class":125},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",2,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":110,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100606104","phase-1-preoperative-imatinib-and-fampridine-in-kit-mutant-gastrointestinal-stromal-tumor-100606104","NCT07171203","Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor","Phase I Study of Preoperative Therapy Imatinib Mesylate and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor (GIST)","Inclusion Criteria:\n\n* Provision of written informed consent prior to any screening procedures\n* Age ≥ 18 years\n* Having been pathologically confirmed to have a KIT exon 11 mutant gastrointestinal stromal tumor assessed for KIT variant mutations by next generation sequencing\n* Treatment naïve gastrointestinal stromal tumor\n* Described as a primary localized, locally advanced, or metastatic gastrointestinal stromal tumor in any location that would benefit from preoperative therapy before tumor surgical resection\n* Has measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors v1.1.\n* Has Eastern Cooperative Oncology Group Performance Status of 0-1\n* Has adequate hematologic, hepatic, and renal function: Absolute Neutrophil Count ≥ 1.5 x 10\\^9\u002FL; Hemoglobin ≥ 11 g\u002FdL; Platelets ≥ 100 x 10\\^9\u002FL; Serum total bilirubin \\\u003C 2.0 x upper limit of normal; Aspartate aminotransferase and alanine aminotransferase ≤ 5 x upper limit of normal; Plasma creatinine phosphokinase \\\u003C 1.5 x upper limit of normal; Serum creatinine ≤ 1.0 x upper limit of normal or calculated creatinine clearance ≥ 50ml\u002Fmin based upon the Cockcroft-Gault Equation\n* Life expectancy of ≥ 5 years\n* Participants able to cause pregnancy agree to use an adequate method of contraception starting with the first dose of study therapy and for 120 days after the last dose\n\nExclusion Criteria:\n\n* Unwilling or unable to comply with the protocol\n* KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing.\n* Non-KIT mutant gastrointestinal stromal tumor\n* Have residual tumor following surgical debulking\n* Have had major surgery within 4 weeks of initiation of study medication.\n* Of childbearing potential\n* Pregnant or nursing.\n* Received imatinib monotherapy prior to the first dose of study treatment with imatinib plus fampridine and has demonstrated tumor shrinkage in computed tomography assessment images.\n* Received fampridine prior to the first dose of study treatment with imatinib plus fampridine.\n* Use of compounded fampridine or other forms of fampridine.\n* Known brain metastases and any other progressive neurologic dysfunction should be excluded from this clinical trial because of their poor prognosis and because their progressive neurologic dysfunction would confound the evaluation of neurologic and other adverse events.\n* Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, cardiac \\[including life threatening arrhythmias\\] disease).\n* Presence of cardiac impairment defined as:\n* Prior history of cardiovascular disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; OR\n* History of myocardial infarction\u002Factive ischemic heart disease within one year of study entry; OR\n* Uncontrolled dysrhythmias; OR\n* Poorly controlled angina.\n* Unresolved toxicity Common Terminology Criteria Adverse Events (CTCAE) Grade ≥ 2 from previous anti-cancer therapy.\n* Allergy or sensitivity to fampridine or known allergies to aminopyridine products, which in the opinion of the investigator(s) suggests an increased potential for an adverse hypersensitivity to fampridine.\n* Allergy to imatinib.\n* Any chronic liver disease including, but not limited to cirrhosis, non-alcoholic steatohepatitis, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic, or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis). Exception: Patients aged ≤ 65 years with non-alcoholic fatty liver disease detected by imaging are acceptable if adequate hepatic function as defined in the inclusion criteria is confirmed. Note: Patients aged \\> 65 years with non-alcoholic fatty liver disease are excluded from the study.\n* Any evidence or history of hepatitis B and\u002For hepatitis C.\n* Medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease that, in the opinion of the investigator(s), would make this study unreasonably hazardous for the patient.\n* Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness\u002Fcondition, which in the judgment of the investigator(s) likely might compromise the safety of the participant or the integrity of the study, interfere with the participant participation in the trial, or compromise the trial objectives.\n* History of seizures.\n* Cannot swallow oral formulations of the medications or lack physical integrity of the upper gastrointestinal tract, or has known malabsorption syndromes. Note: imatinib tablets can be dissolved in water or apple juice if participants have difficulty swallowing.\n* Have taken part in an experimental drug study within 4 weeks of initiating study treatment with imatinib plus fampridine\n* Receiving other anti-neoplastic therapy (e.g., chemotherapy, targeted therapy, or radiotherapy) concurrently or within 4 weeks of starting study treatment with imatinib plus fampridine\n* Receiving medications that inhibit the renal Organic Cation Transporter 2 (OCT2), such as cimetidine and quinidine, because of possible drug-drug interactions.\n* Receiving medications known to be strong inhibitors or inducers of CYP3A4\u002F5.\n* Receiving medications known to be strong inhibitors or inducers of cytochrome CYP2E1 or medications metabolized by cytochrome CYP2B6 or CYP2C9\u002F19 that have narrow therapeutic index and that cannot be discontinued before starting study treatment.",{"count":135,"type":22},18,[112],"The goal of this clinical trial is to learn what dose of the drug fampridine can be given safely together with imatinib (Gleevec) in patients with gastrointestinal stromal tumor (GIST) with a DNA mutation in exon 11 of the KIT gene.\n\nThe main questions this study aims to answer are:\n\n* What is the maximum dose of fampridine that can be given safely together with imatinib (Gleevec)?\n* Is the combination of the two drugs efficacious against the tumor?\n\nParticipants will:\n\n* Take the drugs before tumor surgery (preoperative treatment) for at least 2 months with the option to continue for a longer period of time if treatment seems safe and effective.\n* Visit the clinic at the scheduled appointments for checkups and tests.",[34],[140,141,142,143,144,145,146],"imatinib","fampridine","4-aminopyridine","gastrointestinal stromal tumor","phase 1 trial","KIT exon 11 mutant","voltage-gated potassium channel (VGKC) blocker","2026-05-22",{"date":149,"type":91},"2026-05-27",{"date":151,"type":91},"2026-05-13",{"date":153,"type":22},"2031-07",{"name":155,"class":98},"University of California, San Diego",1,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":110,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":156},"100541168","phase-2-gist-oral-paclitaxelliporaxel-100541168","NCT06326346","GIST Oral Paclitaxel(Liporaxel)","A Phase II Study of Oral Paclitaxel (Liporaxel) in GIST Patients With a Low P-glycoprotein Expression After Failure With Imatinib, Sunitinib and Regorafenib","Inclusion Criteria:\n\n1. Age 20 years or older, at the time of acquisition of informed consent\n2. Histologically confirmed metastatic and\u002For advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene\n3. Failed (progressed and\u002For intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib.\n4. Adequate tissue obtained after treatment failure to imatinib, sunitinib, and regorafenib for P-glycoprotein immunohistochemistry (IHC) analysis, and showed P-glycoprotein expression of less than 6. (For patients with PDGFRα D842V mutation or other subtypes with poor response to tyrosine kinase inhibitors, tumor tissue obtained at any period can be used.)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0\\~2\n6. Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0\n7. At least one measurable lesion as defined by RECIST version 1.1.\n8. Adequate bone marrow, hepatic, renal, and other organ functions\n\n   * Neutrophil \\>1,500\u002Fmm3\n   * Platelet \\> 100,000\u002Fmm3\n   * Hemoglobin \\>8.0 g\u002FdL\n   * Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n   * AST\u002FALT \\\u003C 2.5 x ULN\n   * Creatinine \\\u003C1.5 x ULN\n9. Life expectancy \\> 12 weeks\n10. Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imatinib and regorafenib need 1 week and sunitinib need 2 weeks.)\n11. Provision of a signed written informed consent\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breast feeding\n2. Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration.\n3. If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary\u002Fperipheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.\n4. Uncontrolled infection\n5. Diabetes mellitus with clinically significant peripheral artery disease\n6. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)\n7. Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2\n8. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator\n9. The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleeding event. (required transfusion or endoscopic or surgical intervention)\n10. Patient who underwent major surgery or is under recovery from surgery within 28 days from the study treatment\n11. Known diagnosis of HIV infection (HIV testing is not mandatory).\n12. History of another primary malignancy that is currently clinically significant or currently requires active intervention.\n13. Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging.\n14. Alcohol or substance abuse disorder.\n15. Known severe hypersensitivity to paclitaxel\n16. Received paclitaxel-based treatment for GIST","20 Years",{"count":166,"type":22},28,[168],"PHASE2","The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression.",[34],"2026-04-02",{"date":173,"type":91},"2026-04-07",{"date":175,"type":91},"2024-11-20",{"date":177,"type":22},"2027-03-31",{"name":179,"class":98},"Asan Medical Center",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":110,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":156},"100508858","phase-2-rivoceranib-plus-paclitaxel-in-patients-with-gastrointestinal-stromal-tumor-100508858","NCT05905887","Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor","A Phase 2 Study of Paclitaxel Plus Rivoceranib in Patients With GIST With a High P-glycoprotein Expression After Failure With at Least Imatinib, Sunitinib and Regorafenib","Inclusion Criteria:\n\n* Age 20 years or older, at the time of acquisition of informed consent\n* Histologically confirmed metastatic and\u002For advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene\n* P-glycoprotin IHC score \\> 3 (Tumor tissue with disease progression after regorafenib treatment)\n* Failed (progressed and\u002For intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 \\~ 2\n* Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Adequate bone marrow, hepatic, renal, and other organ functions Neutrophil \\>1,500\u002Fmm3 Platelet \\> 100,000\u002Fmm3 Hemoglobin \\>8.0 g\u002FdL Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) AST\u002FALT \\\u003C 2.5 x ULN Creatinine \\\u003C1.5 x ULN\n* Life expectancy \\> 12 weeks\n* Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.)\n* Provision of a signed written informed consent\n\nExclusion Criteria:\n\n* Women of child-bearing potential who are pregnant or breast feeding\n* Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration.\n* If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary\u002Fperipheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.\n* Uncontrolled infection\n* Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)\n* Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2\n* Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator\n* The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleedig event. (required transfusion or endoscopic or surgical intervention)\n* Currently clinically significant (within 7 days prior to screening) treatment of anticoagulants or other thrombolytic agents. A maximum dose of 325 mg\u002Fday of aspirin is allowed\n* History of uncontrolled hypertension (blood pressure ≥140\u002F90 mmHg and change in antihypertensive medication within 7 days prior to screening) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy.\n* History of clinically serious opearation, bone fracture or non-healing wounds within the last 3 weeks prior to screening\n* History of other significant cardiovascular diseases or vascular diseases, within the last 6 months prior to screening (e.g., hypertensive crisis, and hypertensive encephalopathy or transient ischemic attack or significant peripheral vascular diseases\\] that, in the investigator's opinion, may pose a risk to the patient on VEGFR inhibitor therapy.\n* History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies\n* Known diagnosis of HIV infection (HIV testing is not mandatory).\n* History of another primary malignancy that is currently clinically significant or currently requires active intervention.\n* Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging\n* Alcohol or substance abuse disorder.\n* Known hypersensitivity to rivoceranib or any component of its formulation or history of severe hypersensitivity to including Cremophor R EL(polyoxyethylated castor oil) drug\n* Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19\n* Active bacterial infections",{"count":188,"type":22},48,[168],"The purpose of this study is to evaluate the efficacy and safety of rivoceranib and paclitaxel combination therapy in patients with P-glycoprotein overexpressing GIST who failed standard treatment with imatinib, sunitinib, and regorafenib.",[34],{"date":173,"type":91},{"date":194,"type":91},"2023-09-06",{"date":196,"type":22},"2027-12-31",{"name":179,"class":98},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":110,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":156},"100490093","phase-2-the-efficacy-and-safety-of-temozolomide-in-sdh-deficient-gist-100490093","NCT05661643","The Efficacy and Safety of Temozolomide in SDH-deficient GIST","A Phase 2 Study to Evaluate the Efficacy and Safety of Temozolomide in Advanced Gastrointestinal Stromal Tumor Patients With SDH Deficiency","GIST","Inclusion Criteria:\n\n1. Age 20 years or older, at the time of acquisition of informed consent\n2. Histologically confirmed GIST with CD117(+), DOG-1(+)\n3. Wild type GIST without KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 \\~ 2\n5. Resolution of all adverse events with prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0\n6. At least one measurable lesion by RECIST version 1.1.\n7. Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment\n\n   * Neutrophil \\>1,500\u002Fmm3\n   * Platelet \\> 100,000\u002Fmm3\n   * Hemoglobin \\>8.0 g\u002FdL\n   * Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n   * AST\u002FALT \\\u003C 2.5 x ULN\n   * Creatinine \\\u003C1.5 x ULN\n8. Life expectancy ≥12 weeks\n9. Disease progression or discontinuation of treatment due to intolerable toxicity at least with palliative 1st line imatinib .\n10. Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.)\n11. Provision of a signed written informed consent\n\nExclusion Criteria:\n\n1. Confirmed GIST with KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing\n2. Women of child-bearing potential who are pregnant or breast feeding\n3. Women or men who are not willing to use effective contraception entering the study period or until at least 6 months after the last study drug administration\n4. If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary\u002Fperipheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia\n5. Uncontrolled infection\n6. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible\n7. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator\n8. Known diagnosis of HIV infection (HIV testing is not mandatory).\n9. History of another primary malignancy that is currently clinically significant or currently requires active intervention.\n10. Alcohol or substance abuse disorder\n11. The patients with NTRK fusion\n\n5\\)",{"count":207,"type":22},29,[168],"The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.",[34],{"date":173,"type":91},{"date":213,"type":91},"2023-06-28",{"date":196,"type":22},{"name":179,"class":98},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":110,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100477701","phase-2-assessment-of-compliance-with-monitoring-conducted-by-a-physician-in-person-or-by-a-nurse-in-remote-monitoring-100477701","NCT05500391","Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring","Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring","SUR-CAN","Inclusion Criteria:\n\n* Positive diagnosis (anatomopathology) of tumor within 12 months\n* Patient 18 years of age or older\n* Patient with one of the following conditions:\n\n  1. Desmoid fibromatosis of the abdominal wall operated on or under active surveillance\n  2. Stage I testicular seminoma (whether or not treated with carboplatin AUC7)\n  3. Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)\n  4. Operated GIST with low risk of relapse\n  5. Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated\n  6. Low-grade glioma, operated\n  7. Low-grade neuroendocrine tumor, treated by surgery alone\n* Patient who has given consent to participate in the study\n\nExclusion Criteria:\n\n* Contraindication to imaging tests required for the surveillance plan\n* No telephone\n* Patient under guardianship or curatorship",{"count":225,"type":22},88,[168],"This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\\\u003C12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).",[229,230,34,231,232,233,234,235,236,237,238,239,74,240],"Stage I Testicular Seminoma","Stage I Testicular Nonseminomatous Germ Cell Tumor","Ovarian Germ Cell Tumor","Adenocarcinoma, Clear Cell","Borderline Ovarian Tumor","Sex Cord-Stromal Tumor","Mucinous Adenocarcinoma of Ovary","Carcinoma, Small Cell","Carcinosarcoma, Ovarian","Serous Tumor of Ovary","Glioma","Aggressive Fibromatosis of Abdominal Wall (Disorder)","2026-03-16",{"date":243,"type":91},"2026-03-18",{"date":245,"type":91},"2024-02-28",{"date":247,"type":22},"2032-07",{"name":249,"class":98},"Centre Oscar Lambret",3,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":110,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":156},"100477150","phase-2-imatinib-tdm-in-gist-100477150","NCT05493215","Imatinib TDM in GIST","A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor","Inclusion Criteria:\n\n* Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)\n* Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month\n* Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease\n* Age ≥18 years\n* ECOG performance status of 0 or 1\n* Normal organ function\n\nExclusion Criteria:\n\n* Presence of PDGFRA D842V mutation\n* Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug\n* Concomitant anticoagulation with oral warfarin.\n* Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6\n* Uncontrolled intercurrent illness\n* Concurrent malignancy",{"count":166,"type":22},[168],"Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.",[34],"2026-02-11",{"date":264,"type":91},"2026-02-17",{"date":266,"type":91},"2024-03-26",{"date":268,"type":22},"2027-12",{"name":270,"class":98},"Reema A. Patel",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":110,"phases":280,"briefSummary":281,"conditions":282,"keywords":288,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":312},"100578017","phase-1-a-study-of-the-c-kit-specific-antibody-drug-conjugate-nn3201-for-advanced-andor-metastatic-solid-tumors-known-to-express-c-kit-100578017","NCT06805825","A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","A Phase 1 Dose Escalation and Expansion Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects With Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","Key Inclusion Criteria:\n\nSubjects must meet the following criteria to be eligible for enrollment into the study:\n\n1. Histologically or cytologically confirmed locally advanced, metastatic, and\u002For unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.\n2. Subjects must have received the following treatment:\n\n   Part A (Dose Escalation):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib)\n\n   or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET ChRCC or ccRCC)\n\n   Part B (Dose Expansion):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib) or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC or\n\n   iii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET or ChRCC or ccRCC).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.\n5. Age ≥ 18 years.\n6. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).\n7. Adequate heart function as measured by ECHO\u002FMUGA scan.\n8. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:\n\n   1. Cytotoxic chemotherapy - At least 21 days\n   2. Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days\n   3. Nitrosoureas - At least 6 weeks\n   4. Monoclonal antibody(ies) - At least 28 days\n   5. Radiotherapy - At least 14 days from local site radiation therapy\n9. Negative Serum\u002Furine pregnancy test (for subjects of childbearing potential)\n10. All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile.\n11. Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.\n\nKey Exclusion Criteria:\n\n1. Has received prior therapy with a c-Kit agent (except GIST subjects).\n2. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.\n3. A condition requiring systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drugs (inhaled corticosteroids are allowed).\n4. Any prior treatment-related (i.e., chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and clinically significant at Study Entry, Day -2 to Cycle 1 Day 1.\n5. Major surgery within 30 days before the first dose of study drug treatment in Cycle 1 on Day 1 (port placement for venous access is not considered major surgery).\n6. Significant cardiovascular impairment.\n7. Significant screening electrocardiogram (ECG) abnormalities.\n8. Known active and clinically significant bacterial, fungal, or viral infection.\n9. Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg, despite optimal medical management.\n10. Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening.\n11. Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and\u002For any identified active COVID-19 infection.\n12. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.\n13. People who are pregnant or breastfeeding.\n\nOther inclusion and exclusion criteria must also be met to be eligible to participate in this study.",{"count":279,"type":22},67,[112],"This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and\u002For metastatic solid tumors known to express c-Kit.",[34,283,284,285,74,286,287],"Small-cell Lung Cancer","Adenoid Cystic Carcinoma","Uveal Melanoma","Chromophobe Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma",[204,289,290,291,292,293,294,295,296,34,283,284,285,297,286,287,298,299,300,301,302,303],"SCLC","ACC","NET","ChRCC","ccRCC","Novelty Nobility","cKit","c-kit","Neuroendicrine Tumors","advanced GIST","advanced SCLC","advanced ACC","advanced NET","advanced ChRCC","advanced ccRCC","2025-09-18",{"date":306,"type":91},"2025-09-23",{"date":308,"type":91},"2025-02-03",{"date":196,"type":22},{"name":311,"class":125},"Novelty Nobility, Inc.",5,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":110,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":156},"100467442","phase-2-ctdna-guided-sunitinib-and-regorafenib-therapy-for-gist-100467442","NCT05366816","ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST","ctDNA-Guided Sunitinib And Regorafenib Therapy for Gastrointestinal Stromal Tumor (GIST)","Inclusion Criteria:\n\n1. Patients who are ≥ 18 years of age.\n2. Patients who have histologically confirmed metastatic or unresectable GIST. Unresectable GIST must be confirmed to be unresectable by an experienced surgeon.\n3. Patients who received imatinib prior treatment regimens, including adjuvant therapy, with objective disease progression, inadequate clinical benefit, or intolerance. Additionally, disease progression or intolerance to other systemic therapies including investigational agents and radiotherapy is allowed. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment.\n4. Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.\n5. Patient, or legal guardian if permitted by local regulatory authorities, who provides informed consent to participate in the study.\n6. Presence of proto-oncogene c-KIT (KIT) exon 13 or 17 secondary mutation will be determined through a circulating tumor DNA (ctDNA) blood test or biopsy performed as per standard of care.\n\nExclusion Criteria:\n\n1. Patients who have received prior treatment with sunitinib or regorafenib.\n2. Patients who have received more than 2 different prior tyrosine kinase inhibitor (TKI) treatment regimens. If a patient receives the same TKI more than once sequentially (eg, imatinib followed by a period without systemic therapy and retreatment with imatinib), that will be counted as a single TKI treatment regimen.\n3. Patients who are known to be KIT wild type.\n4. Patients who received any systemic anticancer therapy within 2 weeks before. Prior radiotherapy to major organs within 2 weeks of admission, or focal radiotherapy, such as to bones, limbs, or other areas not involving major organs, within 3 days.\n5. Patients who have clinically significant, uncontrolled, cardiovascular disease, including congestive heart failure Grades II, III or IV according to the New York Heart Association classification, myocardial infarction or unstable angina within the previous 6 months, or uncontrolled hypertension.\n6. Patients who have experienced arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within the 6 months before randomization or venous thrombotic events such as deep vein thrombosis within the 3 months before screening.\n7. Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before screening.\n8. Patients who have a known risk of intracranial bleeding, such as a brain aneurysm or history of intracranial bleeding within 1 year prior to screening.\n9. Patients who have a non-healing wound, ulcer, or bone fracture.\n10. Patients who have poor organ function as defined by one or more of the following laboratory parameters:\n\n    * Persistent proteinuria of NCI-CTCAE version 4.03 Grade 3 or higher\n    * Alanine aminotransferase and aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN) if no hepatic metastases are present; \\> 5 × ULN if hepatic metastases are present.\n    * Total bilirubin \\>1.5 × ULN; and in presence of Gilbert's syndrome, total bilirubin \\> 3 × ULN or direct bilirubin \\> 1.5 × ULN.\n    * Estimated (Cockcroft-Gault formula) or measured creatinine clearance \\\u003C 40 mL\u002Fmin.\n    * Platelet count \\\u003C 90 × 109\u002FL and absolute neutrophil count (ANC) \\\u003C 1.0 × 10\\^9\u002FL.\n    * Hemoglobin \\\u003C 9 g\u002FdL. Transfusion and erythropoietin may be used to reach at least 9 g\u002FdL, but must have been administered at least 2 weeks before screening.\n11. Patients who have received neutrophil growth factor support within 14 days of screening.\n12. Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.\n13. Patients who have had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of screening. Patient has significant traumatic injury within 28 days before screening.\n14. Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 2 years before screening. (The following are exempt from the 2-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.)\n15. Patients who have a history of a seizure disorder requiring anti-seizure medication.\n16. Patients who have metastases to the brain.\n17. Patients who are unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.\n18. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of \\> 450 msec.\n19. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 90 days after the last dose of study drug. Refer to Appendix G for acceptable methods of contraception.\n20. Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the treatment assignment. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false positives) may be enrolled with written consent of the investigator, after pregnancy has been ruled out. Females of non-childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test.\n21. Women who are breastfeeding.\n22. Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism, or excretion of the study drug; or impair the assessment of study results.\n23. Patients with impaired decision-making capacity.",{"count":188,"type":22},[168],"The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.",[34],"2025-09-08",{"date":326,"type":91},"2025-09-09",{"date":328,"type":91},"2023-10-17",{"date":330,"type":22},"2028-12-31",{"name":332,"class":98},"University of Miami",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":110,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":156},"100468881","phase-2-5-years-of-adjuvant-imatinib-in-patients-with-gastrointestinal-stromal-tumor-with-a-high-risk-100468881","NCT05385549","5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk","A Phase 2 Study of 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk of Recurrence Following Surgical Resection","Inclusion Criteria:\n\n1. Age 20 years or older, at the time of acquisition of informed consent\n2. Histologically confirmed GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene\n3. (1) Completely resected localized GIST (R0 resection) within 12 weeks prior to the start of the adjuvant imatinib.\n\n(2) After complete resection(R0 resection), High risk GIST according to Modified NIH criteria and ongoing adjuvant imatinib treatment.\n\n4\\) High risk GIST according to Modified NIH criteria,\n\n1. Tumor rupture according to Nishida classification or\n2. tumor size \\>10cm and mitosis \\>10\u002F50 HPF 5) Eastern Cooperative Oncology Group (ECOG) performance status 0 \\~ 2 6) Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment\n\n   * Neutrophil \\>1,500\u002Fmm3\n   * Platelet \\> 100,000\u002Fmm3\n   * Hemoglobin \\>8.0 g\u002FdL\n   * Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n   * AST\u002FALT \\\u003C 2.5 x ULN\n   * Creatinine \\\u003C1.5 x ULN 7) Provision of a signed written informed consent\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breast feeding\n2. Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration.\n3. If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary\u002Fperipheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.\n4. Uncontrolled infection\n5. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)\n6. Patients who had reduced the dose of imatinib to less than 300 mg\u002Fday due to toxicity.\n7. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator\n8. Known diagnosis of HIV infection (HIV testing is not mandatory).\n9. History of another primary malignancy that is currently clinically significant or currently requires active intervention.\n10. Alcohol or substance abuse disorder.\n11. The patients with PDGFRα D842V mutation",{"count":341,"type":22},35,[168],"In this study, the investigators aim to investigate the efficacy and safety of 5 years of adjuvant imatinib treatment in patients with tumor rupture defined by Nishida classification or those with a tumor size 10cm or larger and a mitotic index of 10\u002F50HPFs or higher.",[34],"2025-08-05",{"date":347,"type":91},"2025-08-08",{"date":349,"type":91},"2022-09-07",{"date":351,"type":22},"2030-04-30",{"name":179,"class":98},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":360,"targetDuration":362,"studyType":24,"phases":4,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":156},"100331963","observational-registry-data-on-gist-patients-100331963","NCT03602092","Observational Registry Data on GIST Patients","The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)","Inclusion Criteria:\n\n1. Patients diagnosed with Gastrointestinal Stromal Tumor\n2. ≥20 years old\n3. Histology-confirmed GIST between 01 January 2010 and 31 December 2020.\n4. Patient with prospective data collection: Willing to provide singed inform-consent as per local regulatory requirements.\n\nExclusion Criteria:\n\n1. Inability and unwillingness to give informed consent if required by site ethic committee.\n2. Patient that is unlikely candidate to obtain long-term follow-up information for reasons of unavailability or with severe concomitant illnesses per investigator judgement",{"count":361,"type":22},3000,"7 Years","This is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with GIST (Gastrointestinal Stromal Tumor) from hospitals in Taiwan.",[34],"2025-05-19",{"date":367,"type":91},"2025-05-22",{"date":369,"type":91},"2018-10-16",{"date":371,"type":22},"2025-12-31",{"name":373,"class":98},"National Health Research Institutes, Taiwan",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":382,"enrollmentInfo":383,"targetDuration":385,"studyType":24,"phases":4,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100376472","observational-study-for-quality-assessment-of-sarcoma-in-european-and-latin-american-multidisciplinary-network-100376472","NCT04181970","Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK","Observational Study, for Quality Assessment, of Sarcoma As a Model to Improve Diagnosis and Clinical Care of Rare Tumors Through a European and Latin American Multidisciplinary NETWORK","(SELNET)","Inclusion Criteria:\n\n* Histological diagnosis of soft-tissue sarcoma, GIST or bone sarcoma (all subtypes) from January 2005 until Juny\u002FSeptember 2023.\n* ≥ 18 years\n* Available clinical and treatment information\n\nExclusion Criteria:\n\nThere is no exclusion criteria","120 Years",{"count":384,"type":22},5000,"30 Months","Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc.\n\nExpert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis.\n\nTumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.",[388,34,389],"Soft-tissue Sarcoma","Bone Sarcoma","2025-03-18",{"date":392,"type":91},"2025-03-21",{"date":394,"type":91},"2019-06-30",{"date":396,"type":22},"2026-09-30",{"name":398,"class":98},"Grupo Espanol de Investigacion en Sarcomas",9,{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":156},"100474727","avapritinib-in-the-treatment-of-unresectable-or-recurrent-metastatic-gist-non-exon18-mutations-of-pdgfra-100474727","NCT05461664","Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA","Avapritinib in the Treatment of Unresectable or Recurrent Metastatic Gastrointestinal Stromal Tumors Non-exon18 Mutations of PDGFRA:A Real-world Study","Inclusion Criteria:\n\n* Patients who are aged ≥ 18 years.\n* Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and\u002For DOG-1-positive by immunohistochemistry.\n* Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).\n* Treatment with Avapritinib.\n* Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.\n* Patient informed consent and signed written consent form.\n* The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* KIT or PDGFRA wild type.\n* Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.\n* Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.",{"count":408,"type":22},74,"This is a prospective, multicenter, observational real-world study to explore the Avapritinib therapy in GIST patients who definited Non-exon18 Mutations of PDGFRA.",[34,411,412],"Unresectable Solid Tumor","Recurrent Metastatic Malignant Neoplasm",[414,415],"Avapritinib","Genetic testing","2025-02-24",{"date":418,"type":91},"2025-02-26",{"date":420,"type":91},"2022-07-10",{"date":371,"type":22},{"name":423,"class":98},"Xinhua Zhang, MD",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":156},"100474974","a-multicenter-study-of-avapritinib-efficacy-and-safety-of-metastatic-or-unresectable-gastrointestinal-stromal-tumors-100474974","NCT05464875","A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors",{"count":408,"type":22},"This is a prospective, multicenter, observational real-world study to explore the therapy patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors.",[34,411,412],[414,415],{"date":418,"type":91},{"date":435,"type":91},"2022-07-09",{"date":371,"type":22},{"name":423,"class":98},{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":16,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":250},"100556321","genetic-bases-of-neuroendocrine-neoplasms-in-mexican-patients-100556321","NCT06523582","Genetic Bases of Neuroendocrine Neoplasms in Mexican Patients","Inclusion Criteria:\n\nAdult patients with a new or previous clinical diagnosis of any of the following conditions:\n\n* Isolated NENs with sporadic presentation, including bronchopulmonary NENs, gastrointestinal NENs, medullary thyroid carcinoma, pancreatic NENs, paragangliomas, pheochromocytomas, pituitary neuroendocrine tumors, and primary hyperparathyroidism.\n* Familial isolated NENs, including familial isolated pituitary adenoma, familial pheochromocytomas and paragangliomas, familial primary hyperparathyroidism, familial gastrointestinal stromal tumors and X-linked acrogigantism.\n* Clinical syndromes encompassing NENs, with familial or sporadic presentation, including Carney complex, Carney-Stratakis syndrome, Carney triad, Cowden syndrome, DICER1 syndrome, Li-Fraumeni syndrome, Lynch syndrome, multiple endocrine neoplasia type 1, multiple endocrine neoplasia type 2, multiple endocrine neoplasia type 4, neurofibromatosis type 1, Pacak-Zhuang syndrome, paraganglioma, pheochromocytoma and pituitary adenoma syndrome, tuberous sclerosis complex, Von Hippel Lindau syndrome.\n\nExclusion criteria:\n\n* Age \\\u003C18 years.\n* Refusal to give informed consent.",{"count":445,"type":22},750,"Neuroendocrine neoplasms (NENs) are a heterogeneous group of lesions derived from cells with the ability to produce hormones that may arise from multiple different organs. Their clinical behavior is quite variable, encompassing both benign lesions and aggressive tumors that invade surrounding and\u002For distant structures. NENs may also cause serious morbidity due to hormone oversecretion. NENs are among the most frequently inherited human tumors, presenting either isolated or as part of syndromes in which a single patient or family develops multiple tumors. There are also non-inherited changes in the genetic information of the tumor cells that are potential targets for treatment. Both inherited and non-inherited DNA defects can be identified using modern routine genetic tests which, unfortunately, are not widely available in Mexico.\n\nThis project seeks to uncover the genetic defects causing NENs in a large cohort of Mexican patients, using three different methods for genetic testing. Adult individuals with various types of NENs from two reference hospitals in Mexico City will be invited to participate. After completing informed consent, blood and, if possible, tissue samples will be obtained from all participants. Clinical details, laboratory results, imaging studies, and histopathological data at disease presentation will be retrieved.\n\nAn initial screening will be performed by analyzing changes in the sequence of multiple genes that have been associated with the occurrence of NENs. In cases with negative screening, a specific method to assess changes in the number of copies of the same genes will also be employed. Finally, sequences of all DNA regions encoding information required to make proteins will be obtained in selected cases. Analyses will be carried out in blood and, if available, also in tumor tissue samples from study participants. Screening of additional family members will be offered.\n\nThis project will accurately describe the repertoire of specific defects causing NENs in the study population, and will likely uncover and characterize novel genetic associations. The results will contribute for a better understanding of the alterations within and outside known driver genes that shape syndromic presentations, tumor behaviors, and inheritance patterns in individuals with NENs. These data will contribute to improve the information on the molecular bases of NENs, including alterations that can be used as therapeutic targets.",[448,449,450,451,452,34,453,454,455,456,457,458,459,460,461,462,463,464,465,466,44,467,468,469,470,471],"Neuroendocrine Neoplasm","Neuroendocrine Neoplasm of Gastrointestinal Tract","Neuroendocrine Neoplasm of Lung","Thymic Neuroendocrine Neoplasm","Neuroendocrine Tumor of Pancreas","Medullary Thyroid Cancer","Paraganglioma","Pheochromocytoma","Primary Hyperparathyroidism","Pituitary Tumor","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Multiple Endocrine Neoplasia Type 4","Carney Complex","Carney Stratakis Dyad","Carney Triad","Cowden Syndrome","DICER1 Syndrome","Li-Fraumeni Syndrome","Von Hippel-Lindau Disease","Familial Isolated Pituitary Adenoma","X-Linked Acrogigantism","Neurofibromatosis 1","Tuberous Sclerosis","2024-07-22",{"date":474,"type":91},"2024-07-26",{"date":476,"type":91},"2022-08-03",{"date":478,"type":22},"2037-03-01",{"name":480,"class":98},"Universidad Nacional Autonoma de Mexico",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":488,"enrollmentInfo":489,"targetDuration":4,"studyType":110,"phases":491,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":156},"100555099","evaluate-the-efficacy-and-safety-of-radiotherapy-combined-with-ripretinib-in-the-treatment-of-unresectable-advanced-gist-100555099","NCT06507683","Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST","A Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST","Inclusion Criteria:\n\n* Voluntary participation and signed informed consent;\n* age: 18 to 75 years, Male or female\n* Patients with histologically confirmed GIST and Imaging evaluated as unresectable recurrent and metastatic disease or locally advanced.\n* ECOG Performance Score: 0-2\n* Subjects who have progressed or documented intolerance after previous first-line, second-line, and third-line treatments.\n* At least one measurable lesion in the abdominal or pelvic cavity that has progressed after frontline treatment\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* estimated life-expectancy less than 3 months.\n* Patients who have received previous radiotherapy to the proposed radiotherapy site, or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent organs, and who are considered unsuitable for radiotherapy after MDT discussion\n* Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.\n* If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period","75 Years",{"count":490,"type":22},32,[492],"NA","The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?",[34],"2024-07-12",{"date":497,"type":91},"2024-07-18",{"date":499,"type":91},"2024-05-28",{"date":501,"type":22},"2027-07",{"name":503,"class":98},"First Affiliated Hospital of Chongqing Medical University",{"id":505,"slug":506,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":488,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":513,"conditions":514,"keywords":515,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":156},"100511351","a-cohort-study-on-the-safety-of-laparoscopic-resection-of-5cm-or-larger-gastric-gastrointestinal-stromal-tumors-100511351","NCT05938309","A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors","A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors","Inclusion Criteria:\n\n1. 18 years \\\u003C age \\\u003C 75 years\n2. Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology\n3. Patient informed consent and willingness to undergo laparoscopic resection\n4. Expected laparoscopic outcome of R0 resection\n5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III\n\nExclusion Criteria:\n\n1. Women during pregnancy or breast-feeding\n2. Severe mental disorder\n3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)\n4. History of gastric surgery (except ESD\u002FEMR for gastric cancer)\n5. History of other malignant diseases within the past five years\n6. History of unstable angina or myocardial infarction within the past six months\n7. History of a cerebrovascular accident within the past six months\n8. History of continuous systematic administration of corticosteroids within one month\n9. Requirement of simultaneous surgery for other diseases\n10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer",{"count":512,"type":22},194,"The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors",[34],[516,517,143],"Gastrectomy","Laparoscopic","2023-07-03",{"date":520,"type":91},"2023-07-10",{"date":522,"type":91},"2023-05-01",{"date":524,"type":22},"2028-05-01",{"name":526,"class":98},"Fujian Medical University",{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":488,"enrollmentInfo":534,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":536,"conditions":537,"keywords":538,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":156},"100505939","clinical-research-of-drug-holiday-based-on-mrd-detection-in-gist-patients-at-high-risk-of-recurrence-100505939","NCT05867901","Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence","Clinical Research of Drug Holiday Based on MRD Detection in Gastrointestinal Stromal Tumor Patients at High Risk of Recurrence","Inclusion Criteria:\n\n* ① Age: ≥18 years and ≤75 years;\n* ② The primary lesion (and metastatic lesion) underwent R0 or R1 surgical resection, and patients were clinically diagnosed with high recurrence risk GIST combined with postoperative pathological results;\n* ③ The patient have received imatinib adjuvant therapy for 3 years after surgery, and no gross lesions were detected by imaging examination, and the possibility of drug withdrawal was considered based on the comprehensive judgment of the doctor in charge;\n* ④ The liquid biopsy for baseline ctDNA is negative;\n* ⑤ Primary Imatinib resistant mutations were not detected by genetic testing, such as SDH-deficient GIST, NF1-mutant GIST, BRAF-mutant GIST and GIST with NTRK3 rearrangement;\n* ⑥ PS score is 0-1 and expected survival time is more than 4 months;\n* ⑦ Patients are willing to stop drug use and observe, and patients and their families could understand the study protocol and voluntarily participate in this study, and signed informed consent. In the follow-up study, they could provide the clinical pathological data and imaging data needed for the study process, cooperate with the follow-up and collect the blood of the clinical efficacy evaluation, and agree to use the test data for the follow-up study and product development.\n\nExclusion Criteria:\n\n* ① Fresh or paraffin tissue of the surgical tumor is not available;\n* ② Not receiving the assigned treatment or change therapy before disease progression;\n* ③ Unable to cooperate with follow-up with the study according to defined clinical period;\n* ④ Unable to take or provide defined imaging assessment examinations;\n* ⑤ Other conditions that investigators consider inappropriate for enrollment.",{"count":535,"type":22},40,"This study is aimed:\n\n* to evaluate the dynamic monitoring value of MRD detection for postoperative recurrence in high-risk GIST patients;\n\n  * to evaluate the effect of drug holiday mode based on MRD detection on progression-free Survival (PFS) and\u002For overall survival (OS) after drug withdrawal for high-risk GIST patients who have achieved disease control after long-term use of imatinib; ③ to investigate the response rate of imatinib re-use in patients who developed disease progression after drug withdrawal; ④ to explore whether the \"drug holiday\" treatment mode based on MRD detection could delay the occurrence of secondary imatinib resistance mutations for high-risk GIST patients with long-term use of imatinib after surgery.",[34],[34,539,540,541],"Drug Holiday","Minimal Residual Disease","Circulating Tumor DNA","2023-05-27",{"date":544,"type":91},"2023-05-31",{"date":546,"type":22},"2023-06-01",{"date":548,"type":22},"2027-06-30",{"name":550,"class":98},"Peking University People's Hospital",{"id":552,"slug":553,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":110,"phases":560,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":156},"100497014","apatinib-mesylate-versus-standard-second-line-tki-in-the-treatment-of-advanced-gist-100497014","NCT05751733","Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST","Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced Gastrointestinal Stromal Tumors: a Randomized, Open, Controlled, Single-center Clinical Study","Inclusion Criteria:\n\n1. Patients were enrolled voluntarily and signed a written informed consent with good compliance and follow-up;\n2. Age ≥18 years (calculated on the date of signing the informed consent) for both men and women;\n3. Previous first-line TKI (Imatinib\u002FAvatinib) therapy and eventual treatment failure (disease progression or toxicity intolerance during treatment);\n4. Subjects who provide pre-C-Kit \u002FPDGFRA test reporting can provide 10ml blood sample and fresh or archived tumor tissue for genetic testing.\n5. ECOG score: 0 \\~ 1;\n6. Predicted survival ≥12 weeks.\n\nExclusion Criteria:\n\n1. Previous molecular targeted therapy other than imatinib\u002FAvatinib for the treatment of gastrointestinal stromal tumor;\n2. Toxicity of previous imatinib\u002FAvatinib treatment or other treatments has not recovered or reached NCICTCAE5.0≤ level 1;\n3. Patients with clinical symptoms of ascites or pleural effusion who need puncture drainage or who have received thoracic and ascites drainage within 1 month before signing informed consent, except those who only show a small amount of ascites or pleural effusion without clinical symptoms;\n4. A second primary malignancy within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been adequately treated;\n5. Gastrointestinal stromal tumor with central nervous system metastasis;\n6. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption.",{"count":559,"type":22},258,[492],"The goal of this Mesylate apatinib versus standard second-line TKI in the treatment of advanced gastrointestinal stromal tumors: a randomized, open, controlled, single-center clinical study is to explore the efficacy and safety of Apatinib compared with second-line treatment in advanced GIST patients with first-line TKI failure. The main questions it aims to answer are:\n\n* To explore the efficacy and safety of Apatinib compared with standard second-line treatment for GIST with advanced first-line TKI failure.\n* To explore the expression level and MVD value of VEGFR2 in GIST, and to explore the relationship between the expression level and the location, size, mitotic image and recurrence risk grading of GIST.\n\nPatients with advanced GIST were randomly included in the trial group and the control group at a ratio of 1:1.",[34],[34,564,565],"Apatinib mesylate","tyrosine kinase inhibitors","2023-03-01",{"date":568,"type":91},"2023-03-02",{"date":570,"type":91},"2023-02-01",{"date":572,"type":22},"2027-01-01",{"name":574,"class":98},"Xiangya Hospital of Central South University",{"id":576,"slug":577,"hasResults":11,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":156},"100470671","prediction-of-postoperative-treatment-efficacy-and-recurrence-risk-of-high-risk-gist-based-on-liquid-biopsy-mrd-100470671","NCT05408897","Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Liquid Biopsy MRD","Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Minimal Residual Disease Detected by Liquid Biopsy","Inclusion Criteria:\n\n* Patients aged between 18 and 80\n* Patients suspected for high-risk GIST by preoperative imaging examinations or diagnosed with high-risk GIST by pathological biopsy, who have not received preoperative neoadjuvant treatment\n* Patients must have not received any treatment including radiotherapy, chemotherapy or surgery\n* The function of other organs including liver and kidneys is good enough so that the patients could tolerate targeted therapy and surgery\n* Postoperative pathology conformed the diagnosis of high-risk GIST\n* Patients and their families could understand the protocol of this study and voluntarily agree to participate in. Signed informed consents are required\n\nExclusion Criteria:\n\n* Previous medical history of malignant tumors or synchronous other malignancies\n* Emergent surgery because of bowel obstruction, perforation or bleeding\n* Pregnant or lactant women\n* Medical history of severe mental illness\n* Patients with contraindication for targeted therapy and surgery\n* Non-R0 resection\n* Postoperative pathology conformed the diagnosis of non-high-risk GIST\n* Patients with distant metastasis\n* Other situations in which researchers consider that the patient is unsuitable for this study",{"count":583,"type":22},45,"So far, MRD assessment by liquid biopsy (ctDNA) has not been used to predict postoperative treatment efficacy and recurrence risk of GIST patients because of special disease characteristics and technological limitations. Therefore, we conducted this prospective multi-center, single-arm observational study to collect 45 operable patients with locally advanced, suspected high-risk GIST. NGS genetic testing platform is used to detect tumour tissues and peripheral ctDNA will also be dectected. we try to explore the correlation between PFS\u002FOS and MRD in high-risk GIST patients by analyzing the relationship between dynamic changes in ctDNA mutation spectrum and postoperative adjuvant therapy efficacy, and to evaluate MRD-based genomic characteristics to guide further treatment.",[34,540],"2022-09-18",{"date":588,"type":91},"2022-09-21",{"date":590,"type":91},"2022-01-01",{"date":592,"type":22},"2028-04",{"name":550,"class":98}]