[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gist\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gist":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,71,146,159,193,235,260,288,317,348],{"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":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053362","phase-1-a-study-of-inlexisertib-dcc-3116-in-combination-with-anticancer-therapies-in-participants-with-advanced-malignancies-100053362",false,"NCT05957367","A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies","A Master Protocol for the Multi-Cohort, Phase 1\u002F2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Module A: Part 1 and Part 2:\n\nModule A Part 1 and Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.\n\n* Module B: Only for Part 1 (Safety\u002FDose-finding):\n\n  * Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation\n  * Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it\n  * Must not have received prior ripretinib treatment\n* Module B: Only for Part 2 (Expansion)\n\n  * Pathologically confirmed GIST with documented mutation in KIT exon 11\n  * Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST\n* Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)\n* Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1\n* Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening\n* Must provide a fresh tumor biopsy, if able\n\nExclusion Criteria:\n\n* Must not have received the following within the specified time periods prior to the first dose of study drug:\n\n  1. Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer)\n  2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter)\n  3. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days\n  4. Grapefruit or grapefruit juice: 14 days\n* Have not recovered from all clinically relevant toxicities from prior therapy\n* New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug\n* Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease\n* Malabsorption syndrome\n* Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug\n* Major surgery within 4 weeks of the first dose of study drug\n* Active HIV, Hepatitis B or Hepatitis C infection","ALL","18 Years",{"count":19,"type":20},94,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1\u002F2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.",[27],"GIST",[29,30,31],"Advanced gastrointestinal stromal tumors","gastrointestinal stromal tumors","ripretinib","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2023-09-28",{"date":40,"type":20},"2029-03",{"name":42,"class":43},"Deciphera Pharmaceuticals, LLC","INDUSTRY",27,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100054129","lrg-gist-patient-registry-100054129","NCT07697248","LRG GIST Patient Registry","Life Raft Group GIST Registry Protocol","Inclusion Criteria:\n\n1. Gastrointestinal Stromal Tumor diagnosis\n2. Provide written and informed consent\n\nExclusion Criteria:\n\n\\-",{"count":53,"type":20},5000,"25 Years","OBSERVATIONAL","The Life Raft Group (LRG) Patient Registry is a structured database that collects comprehensive information about individuals diagnosed with GIST. The purpose of this registry is to facilitate research, improve understanding of the disease, track patient outcomes, and ultimately enhance patient care.",[27,58,59],"GIST - Gastrointestinal Stromal Tumor","Gastrointestinal Stromal Tumor (GIST)",[27],"2026-07-08",{"date":35,"type":36},{"date":64,"type":36},"2013-04",{"date":66,"type":20},"2099-12-31",{"name":68,"class":69},"The Life Raft Group","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":80,"conditions":81,"keywords":127,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":70},"100289631","familial-investigations-of-childhood-cancer-predisposition-100289631","NCT03050268","Familial Investigations of Childhood Cancer Predisposition","SJFAMILY","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown below, you may enroll regardless of the results of your clinical genetic testing.\n\nDEFINITION OF FAMILIAR CANCER FOR THIS PROTOCOL:\n\nIn this protocol, the definition of \"Familial Cancer\" is met if any of the following is present:\n\n* An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR\n* An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR\n* An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome; OR\n* An individual with a congenital cancer diagnosed before 6 months of age; OR\n* An individual with a rare pediatric cancer or tumor diagnosed before 26 years of age\n\nº Excluding human papilloma virus-associated cervical cancer and non-melanoma skin cancer occurring in adults.\n\nINCLUSION CRITERIA:\n\n* An individual who meets this protocol's definition of \"Familial Cancer,\" as above.\n* Biologic relatives of an individual meeting this protocol's definition of \"Familial Cancer,\" who are either affected or unaffected by cancer.\n\nEXCLUSION CRITERIA:\n\n* An inability or unwillingness of the research participant or his\u002Fher legally authorized representative (LAR) to provide written informed consent.\n* The participant has received allogeneic bone marrow transplantation and has NO pre-transplant germline (cancer-unaffected) DNA available AND is unwilling to provide a skin sample.",{"count":79,"type":20},1500,"NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing.\n\nWhile it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition.\n\nThe purpose of this protocol is to identify novel cancer predisposing genes and\u002For genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer.\n\nPRIMARY OBJECTIVE:\n\n* Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members.\n\nSECONDARY OBJECTIVE:\n\n* Identify novel cancer predisposing genes and\u002For genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.",[82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,27,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126],"Acute Leukemia","Adenomatous Polyposis","Adrenocortical Carcinoma","AML","BAP1 Tumor Predisposition Syndrome","Carney Complex","Choroid Plexus Carcinoma","Constitutional Mismatch Repair Deficiency Syndrome","Diamond-Blackfan Anemia","DICER1 Syndrome","Dyskeratosis Congenita","Emberger Syndrome","Familial Acute Myeloid Leukemia","Familial Adenomatous Polyposis","Fanconi Anemia","Familial Cancer","Familial Wilms Tumor","Familial Neuroblastoma","Hereditary Breast and Ovarian Cancer","Hereditary Paraganglioma-Pheochromocytoma Syndrome","Hodgkin Lymphoma","Juvenile Polyposis","Li-Fraumeni Syndrome","Lynch Syndrome","MDS","Melanoma Syndrome","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Neuroblastoma","Neurofibromatosis Type 1","Neurofibromatosis Type II","Nevoid Basal Cell Carcinoma Syndrome","Non Hodgkin Lymphoma","Noonan Syndrome and Other Rasopathy","Overgrowth Syndromes","Pancreatic Cancer","Peutz-Jeghers Syndrome","Pheochromocytoma\u002FParaganglioma","PTEN Hamartoma Tumor Syndrome","Retinoblastoma","Rhabdoid Tumor Predisposition Syndrome","Rhabdomyosarcoma","Rothmund-Thomson Syndrome","Tuberous Sclerosis","Von Hippel-Lindau Disease",[128,129,130,131,132,133,134,135,136],"Familial cancer","Genetic predisposition","Heritable disease","Cancer risk","Genome analysis","Genetic modifiers","Next generation sequencing (NGS)","Genetic counseling","DNA","2026-06-15",{"date":139,"type":36},"2026-06-17",{"date":141,"type":36},"2017-04-06",{"date":143,"type":20},"2037-03-31",{"name":145,"class":69},"St. Jude Children's Research Hospital",{"id":147,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":25,"conditions":150,"keywords":151,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":157,"locationsCount":158},"100512816",{"count":19,"type":20},[23,24],[27],[29,30,31],"2026-06-01",{"date":154,"type":36},"2026-06-02",{"date":38,"type":36},{"date":40,"type":20},{"name":42,"class":43},26,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100624207","phase-2-kqb198-in-combination-with-imatinib-in-participants-with-advancedmetastatic-gist-in-1st-line-setting-100624207","NCT07406633","KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GIST in 1st Line Setting","A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GI Stromal Tumor in 1st Line Setting","Inclusion Criteria\n\nAll Participants:\n\n* Unresectable or metastatic disease\n* Tissue confirmation of GIST\n* Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).\n* Measurable disease per RECIST v1.1.\n* Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.\n* Adequate organ function and performance status\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Unable to swallow or GI condition that prevents absorption.\n* Other active malignancies within the last 2 years.\n* History of hypersensitivity to any component of KQB198 or imatinib.",{"count":167,"type":20},46,[24],"This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.",[58,27,171,172,173],"GIST Metastatic Cancer","Gastro Intestinal Stromal Tumour","Gastrointestinal Tumors",[175,176,177,178,179,180,181,182],"KQB198","imatinib","gleevec","gist","gastrointestinal stromal tumor","gastro intestinal stromal tumor","gist first line","gist 1st line","2026-05-18",{"date":185,"type":36},"2026-05-19",{"date":187,"type":20},"2026-05",{"date":189,"type":20},"2028-10",{"name":191,"class":43},"Kumquat Biosciences Inc.",8,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":201,"maxAge":17,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":213,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100549997","phase-1-phase-i-trial-to-determine-the-dose-and-evaluate-the-pk-and-safety-of-lutetium-lu-177-edotreotide-therapy-in-pediatric-participants-with-sstr-positive-tumors-100549997","NCT06441331","Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).","KinLET","Key Inclusion Criteria:\n\n* Participants aged ≥ 2 years and \\\u003C 18 years\n* Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.\n* Tumor which is relapsed or is refractory to at least one line of previous therapy\n* Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample\n* Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)\u002F computed tomography (CT) or positron emission tomography (PET)\u002FCT imaging, which is higher than the liver uptake)\n* Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial\n* In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT\n\nScreening Consent Participant\u002Flegal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA\u002FEdotreotide, or excipients\n* Previous history of acute leukemia unless in remission for at least two years\n* Extensive bone\u002Fbone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells\u002Fkg\n* Patients who have received previous systemic targeted RPT\n* Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with oncologic immune vaccine or CAR-T cell therapy\n* Bulky disease in the CNS\n* Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction\n* Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment\n* Pregnant or breastfeeding women.\n* Other known malignancies.\n* Serious non-malignant disease.","24 Months",{"count":203,"type":20},20,[23],"The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \\\u003C18 years of age with somatostatin receptor (SSTR)-positive tumors.",[207,208,209,210,211,123,212,27],"Somatostatin Receptor Positive","NETs","Lymphoma","Solid Tumor","CNS Tumors","Peripheral Primitive Neuroectodermal Tumor",[214,215,216,209,217,218,219,220,221,222,223,224],"Pediatric","CNS tumors","Solid tumors","Somatostatin Receptor (SSTR)-positive Tumors","Lutetium Lu 177 Edotreotide","Targeted RPT","ITM","GEP-NET","Neuroendocrine tumors","Radiopharmaceutical Therapy","Childhood","2026-04-27",{"date":227,"type":36},"2026-05-01",{"date":229,"type":36},"2025-09-26",{"date":231,"type":20},"2034-04",{"name":233,"class":43},"ITM Solucin GmbH",5,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":70},"100600370","phase-1-lenvatinib-after-progression-on-imatinib-sunitinib-and-regorafenib-for-gist-patients-100600370","NCT07096609","Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients","A Single-center, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Lenvatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) Who Have Failed Treatment With Imatinib, Sunitinib, and Regorafenib","LONGIST","Inclusion Criteria:\n\n1. Age ≥ 20 years at the time of providing written informed consent.\n2. Histologically confirmed metastatic and\u002For advanced (unresectable or recurrent) GIST with positivity for CD117(+), DOG-1(+), or harboring mutations in the KIT or PDGFRα genes.\n3. Documented failure of prior treatment with imatinib, sunitinib, and regorafenib due to disease progression and\u002For intolerance.\n\n   * Note: There is no limitation on the number of prior therapies. Prior use of other tyrosine kinase inhibitors (TKIs) or chemotherapy in combination with imatinib, sunitinib, or regorafenib is permitted.\n   * Disease progression is defined as:\n\n     1. Increase in tumor size by ≥ 20% per mRECIST version 1.1\n     2. Emergence of unequivocal new lesions (excluding newly developed small cystic liver lesions within 6 months after initiation of TKI treatment)\n     3. Appearance of new solid nodules within cystic masses\n     4. Increase in the size of existing solid nodules within cystic masses (\\>20%)\n   * Intolerance to prior TKIs is defined as:\n\n     1. Drug compliance \\\u003C75% due to ≥ Grade 2 non-hematologic toxicity, despite dose reduction to one level below the standard dose (i.e., imatinib 300 mg\u002Fday; sunitinib 37.5 mg\u002Fday on a 4-week on\u002F2-week off schedule or 25 mg\u002Fday on a continuous schedule; regorafenib 120 mg\u002Fday)\n     2. Despite the same dose reduction as above, the occurrence of febrile neutropenia, Grade 4 neutropenia lasting more than 6 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3-4 or persistent ≥ Grade 2 non-hematologic toxicity deemed intolerable\n4. ECOG performance status of 0-2.\n5. All toxicities from previous treatments must have recovered to Grade 0 or 1 as per NCI-CTCAE version 5.0.\n6. At least one measurable lesion as defined by mRECIST version 1.1.\n7. Adequate bone marrow, liver, renal, and other organ function:\n\n   * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³\n   * Platelets ≥ 100,000\u002Fmm³\n   * Hemoglobin ≥ 8.0 g\u002FdL\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * AST\u002FALT ≤ 2.5 × ULN (or ≤ 5 × ULN in case of liver metastases)\n   * Serum creatinine ≤ 1.5 × ULN\n8. Life expectancy ≥ 12 weeks\n9. A washout period equivalent to at least 4 times the half-life of previous TKI or chemotherapeutic agents is required(Imatinib and regorafenib: ≥ 1 week; Sunitinib: ≥ 2 weeks)\n10. Signed written informed consent\n\nExclusion Criteria:\n\n1. Women of childbearing potential who are pregnant or breastfeeding\n2. Women or men unwilling to use effective contraception during the study treatment period and for 6 months after the last dose of the investigational drug\n3. All participants (both men and women) must use barrier contraception during the treatment period and for at least 1 month after the final dose\n4. Women of childbearing potential are defined as sexually mature females who have not undergone hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., had menstruation within the past 12 months)\n5. History of any of the following within 6 months prior to enrollment: myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass surgery, congestive heart failure classified as NYHA Class III or IV, stroke or transient ischemic attack (TIA), or clinically significant arrhythmias requiring treatment\n6. Uncontrolled active infection\n7. Diabetes mellitus with clinically significant signs of peripheral vascular disease\n8. Acute or chronic liver disease, or any chronic hepatic disorder (patients with stable chronic hepatitis B are eligible)\n9. Uncontrolled gastrointestinal toxicities greater than Grade 2 according to NCI-CTCAE (e.g., nausea, diarrhea, vomiting)\n10. Any severe acute or chronic medical or psychiatric condition, or clinically significant abnormal laboratory finding, that may increase the risk associated with study participation or investigational drug administration, or interfere with the interpretation of study results, as determined by the investigator\n11. History of life-threatening bleeding or any Grade 3 or 4 bleeding event requiring transfusion, endoscopic intervention, or surgical procedure within 3 months prior to initiation of study drug\n12. Treatment with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to consent that, in the opinion of the investigator, may put the patient at risk. Use of aspirin is permitted up to a maximum dose of 325 mg\u002Fday\n13. Uncontrolled hypertension (blood pressure ≥ 140\u002F90 mmHg) that is not adequately managed with medication, or change in antihypertensive regimen within 7 days prior to consent; such patients may be at increased risk during VEGF inhibitor therapy\n14. Major surgery, significant trauma (e.g., bone fracture), or non-healed wounds within 3 weeks prior to consent (procedures such as catheter insertion are not considered major)\n15. History of other significant cardiovascular or vascular conditions within 6 months prior to consent that, in the opinion of the investigator, may place the patient at risk during VEGF inhibitor therapy, including but not limited to hypertensive crisis, hypertensive encephalopathy, stroke, transient ischemic attack (TIA), or clinically significant peripheral vascular disease\n16. Clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other history of renal failure\n17. Known diagnosis of HIV infection (HIV testing is not mandatory)\n18. History of another primary malignancy that has recently become clinically significant or currently requires active intervention\n19. Evidence of brain metastasis on radiological imaging (e.g., CT or MRI) in patients presenting with symptoms suggestive of central nervous system involvement\n20. History of alcohol or substance abuse disorder","20 Years",{"count":245,"type":20},48,[23,24],"The aim of this study is to evaluate the safety and efficacy of lenvatinib in patients with metastatic or advanced GIST who have failed at least imatinib, sunitinib, and regorafenib treatment.",[27],[27,250],"Lenvatinib","2026-04-02",{"date":253,"type":36},"2026-04-03",{"date":255,"type":36},"2025-10-29",{"date":257,"type":20},"2027-12-31",{"name":259,"class":69},"Asan Medical Center",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":287},"100624552","rct-of-eftr-versus-ster-for-gist-treatment-100624552","NCT07411118","RCT of EFTR Versus STER for GIST Treatment","Exposed Endoscopic Full Thickness Resection (EFTR) Versus Submucosal Tunnelling Endoscopic Resection (STER) for Small Gastric Gastrointestinal Stromal Tumor (GIST) - an International Double Blinded Randomized Controlled Trial","Consecutive adult patients age \\>=18 and \\\u003C=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility.\n\nInclusion Criteria:\n\n* Presence of gastric subepithelial tumor on diagnostic upper endoscopy, and\n* Diagnostic EUS and CT scan with intravenous contrast suspicious of GIST arising from muscularis propria layer, size with maximum diameter \\>=1.0cm and \\\u003C= 3.5cm, and\n* Absence of high risk features, including irregular margins, invasion to surrounding organs, lesion hypervascularity, and\n* Endoscopic morphology and location deemed feasible with both EFTR and STER by an expert endoscopist, or\n* Histological confirmation of GIST through EUS guided fine needle biopsy (Optional, based on recommendation from guidelines)\n\nExclusion Criteria:\n\n* Patients with tumors deemed not suitable for endoscopic resection (Either EFTR or STER), due to unfavourable location, high risk morphology, or any other reasons.\n* Patients with multiple tumors.\n* Patients unable or unwilling to provide consent.\n* Previous esophageal or gastric surgery.\n* Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.\n* Pregnant women or those planning pregnancy or breastfeeding women.\n* Uncorrectable coagulopathy defined by international normalized ratio (INR) \\> 1.5 or platelet count \\\u003C 50000\u002Fµl.\n* Patients on double anti-platelet agents or anti-coagulation (Warfarin, heparin or other direct oral anticoagulants)","75 Years",{"count":269,"type":20},136,[271],"NA","Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST. We hypothesize that EFTR could achieve better complete margin negative resection than STER without increase in adverse event.\n\nThis is an international multi-center double blinded randomized controlled trial involving four high volume centers from Hong Kong, mainland China, India and Japan. Adult patients with clinical 1.0-3.Scm gastric GIST undergoing endoscopic resection would be recruited.\n\nPatients would be randomized to undergo EFTR (intervention) or STER (Control) by expert endoscopists under general anaesthesia according to well published methods.",[274,27],"Small Size Gastrointestinal Stromal Tumors",[276,277,27],"EFTR","STER","2026-02-09",{"date":280,"type":36},"2026-02-13",{"date":282,"type":36},"2025-02-01",{"date":284,"type":20},"2033-02-01",{"name":286,"class":69},"Chinese University of Hong Kong",4,{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":297,"studyType":55,"phases":4,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":70},"100501059","the-australia-and-new-zealand-multicentre-upper-gastrointestinal-endoscopic-tissue-resection-study-100501059","NCT05804331","The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study","ANZ UGI","Inclusion Criteria:\n\n* UGI neoplastic lesions \\> 10mm\n\n  * Lesions for ESD limited to the mucosal and\u002For submucosal layer OR\n  * Lesions for EFTR limited to the muscularis propria layer OR\n  * Lesions for STER limited to the submucosal and\u002For muscularis propria layer\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Age less than 18\n* Unable to give informed consent\n* Pregnant or lactating patients\n* Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally",{"count":296,"type":20},500,"3 Years","To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions",[300,301,302,303,304,27,305,306,307],"Cancer of Stomach","Oesophageal Cancer","Gastric Cancer","Gastric Adenocarcinoma","GI Cancer","Neuroendocrine Tumors","Gastric Neoplasm","Esophageal Neoplasms","2025-03-25",{"date":310,"type":36},"2025-03-27",{"date":312,"type":36},"2023-03-14",{"date":314,"type":20},"2028-09-14",{"name":316,"class":69},"Western Sydney Local Health District",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100473299","targeted-therapy-drug-monitoring-in-digestive-oncology-100473299","NCT05443087","TARGETed Therapy Drug MONITOring in DIGestive Oncology","Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future","TARGETMONITO","Inclusion Criteria:\n\n1. Patient aged 18 years or over\n2. Advanced digestive cancer (histologically confirmed or confirmed by imaging for HCC) for which a standard treatment (according to each drug SmPC and as per standard of care) planned with:\n\n   * Regorafenib for GIST, mCRC, and HCC,\n   * Everolimus for gepNET,\n   * Sunitinib for pNET or GIST,\n   * Cabozantinib for HCC,\n   * Encorafenib - cetuximab for mCRC\n3. Life expectancy of greater than 3 months - at the discretion of the investigator\n4. Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)\n5. Patients must be affiliated to a Social Security System (or equivalent)\n6. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n\nExclusion Criteria:\n\n1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied\n2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy\u002Fprocedure excluding alopecia and peripheral neuropathy\n3. Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If different MKI molecules (from the one(s) planned in the study) have been previously taken, a wash out period of 2 weeks before treatment should be observed.\n4. Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin\n5. Any condition that may jeopardize patient participation in the study as well as non contraception for male and female with child-bearing potential, pregnancy or breast feeding.\n6. Patient unwilling or unable to comply with the medical follow-up required by the standard treatment taken (including PK sampling during treatment phase and vital status collection during follow-up phase) because of psychosocial, familial, social or geographical reasons\n7. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product which have a marketed authorisation, used as per the SmPC for the given indication)\n8. Patient deprived of their liberty or under protective custody or guardianship",{"count":326,"type":20},330,[271],"Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.",[330,331,332,27,305],"Digestive Cancer","Metastatic Colorectal Cancer","Hepatocellular Carcinoma",[334,335,336,337,338],"multi kinases inhibitors","therapeutic drug monitoring","pharmacokinetics","pharmacodynamics","advanced digestive cancers",{"date":340,"type":36},"2025-03-30",{"date":342,"type":36},"2022-08-29",{"date":344,"type":20},"2027-06",{"name":346,"class":69},"UNICANCER",29,{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":355,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":358,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":70},"100565298","phase-3-a-study-of-olverembatinib-in-sdh-deficient-gist-100565298","NCT06640361","A Study of Olverembatinib in SDH-deficient GIST.","A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.\n2. Must have at least one measurable target lesion.\n3. ECOG≤ 2.\n4. Expected survival of at least 3 months.\n5. Adequate organ function.\n6. Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.\n7. Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug.\n8. Prior to initiation of any screening or study-specific procedures, the patient or his\u002Fher guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.\n2. Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.\n3. Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.\n4. Adverse events due to prior treatment have not recovered (\\> NCI CTCAE v5.0 Grade 1).\n5. Absorption disorder syndrome or other conditions that affect the absorption of oral medications.\n6. With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.\n7. Poorly controlled hypertension after hypertension medication.\n8. Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.\n9. Uncontrolled Hyperlipidemia.\n10. Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.\n11. With brain metastases.\n12. Other malignancies within 2 years.\n13. Uncontrolled systemic active fungal, bacterial, and\u002For viral infections.\n14. Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.\n15. Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.","12 Years",{"count":357,"type":20},40,[359],"PHASE3","An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.",[27],[363,27],"Olverembatinib","2024-12-23",{"date":366,"type":36},"2024-12-27",{"date":368,"type":36},"2024-11-11",{"date":370,"type":20},"2029-06-30",{"name":372,"class":43},"Ascentage Pharma Group Inc."]