[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sorafenib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sorafenib":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100628593","phase-3-mrd-guided-maintenance-post-hct-gilteritini-vs-sorafenib-100628593",false,"NCT07463651","MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib","Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients","TROPHY-15","Inclusion Criteria:\n\n* Informed consent and willingness to participate in this clinical study;\n\n  * Gender is not limited, age range is 14-70 years old (including threshold);\n\n    * ECOG score 0-2 points;\n\n      * Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;\n\n        * Successfully accepted allo HSCT, with no restrictions on the pre-treatment protocol, allowing any donor source \\[fully matched cell, unrelated donor (URD), incompatible unrelated donor, haploidentical relative donor or umbilical cord blood\\], allowing any graft source \\[umbilical cord blood, bone marrow (BM), peripheral blood (PB)\\]; ⑥ Patients with complete morphological remission (CR) prior to allo HSCT, and FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6);\n\n          ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500\u002Fμ L, platelet count ≥ 20000\u002Fμ L and not dependent on infusion), oral administration of investigational drugs, exclusion of overlap syndrome, complete donor chimerism (FDC) status, no activity requiring daily prednisone dose\\>0.5 mg\u002Fkg, acute GVHD;\n\n          ⑧ Clinical laboratory tests meet the following criteria: a. Serum creatinine ≤ 2.0 times the upper limit of normal value; b. Total bilirubin ≤ 2.5 mg\u002FdL (excluding Gilbert syndrome patients); c. Serum AST and\u002For ALT\\\u003C3 times the upper limit of normal values;\n\n          ⑨ Maintenance treatment should be started 60 to 90 days after transplantation;\n\n          ⑩ Female participants must meet the following criteria: have undergone menopause (at least 1 year without menstruation) or surgical sterilization (at least 1 month ago) before screening for infertility; Or have the ability to conceive but agree not to plan pregnancy during the study period and within 6 months after the last dose; Conduct pregnancy tests during the screening period; If there is heterosexual behavior, agree to continue using local standard high-efficiency contraceptive measures plus barrier method from the beginning of screening to 6 months after the last administration; Agree not to breastfeed or donate eggs during the study period and for 6 months after the last administration Male participants must meet the following requirements: male participants (even if sterilized) and their reproductive partners must use efficient contraception plus barrier method during the study period and within 127 days after the last dose; Male participants are not allowed to donate sperm during the study period and for 127 days after the last dose;\n\nExclusion Criteria:\n\n* Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;\n\n  * Any serious comorbidities that make patients unsuitable for participation in this study or may affect protocol compliance;\n\n    * FLT3-ITD molecular MRD positivity before maintenance therapy;\n\n      * Severe organ dysfunction such as organ failure occurs after allogeneic hematopoietic stem cell transplantation;\n\n        * Subjects who are positive for hepatitis B B surface antigen (HBsAg) and whose hepatitis B virus (HBV) DNA titer is higher than the upper limit of the normal value range of the research center, and who are judged by the researchers not suitable for this study; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; Individuals who are HIV antibody positive; Positive syphilis test results;\n\n          ⑥ There is evidence within the first 6 months of enrollment that the patient has other diseases or physiological conditions that may interfere with the evaluation results of this trial, or complications that seriously endanger life, including but not limited to uncontrolled infections, pulmonary arterial hypertension, severe heart failure (NYHA grades III and IV), unstable angina or acute myocardial infarction, poorly controlled refractory hypertension (based on hospitalization medical records diagnosis), etc;\n\n          ⑦ Individuals with mental or neurological disorders who are unable to express their wishes correctly;\n\n          ⑧ Individuals who have had active malignant solid tumors within the past 5 years prior to participating in this study, except for cervical cancer, localized prostate cancer in situ, and non melanoma skin cancer that have been cured;\n\n          ⑨ Have participated in or are currently participating in other clinical trials within one month prior to enrollment;\n\n          ⑩ Researchers have determined that individuals are not suitable to participate in this clinical trial.","ALL","14 Years","70 Years",{"count":21,"type":22},594,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.\n\nAll patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.\n\nStudy Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.",[28,29,30,31,32,33],"Acute Myeloid Leukemia (AML)","FLT3-ITD Mutation","Allogeneic Hematopoietic Cell Transplantation (HCT)","Maintenance Therapy","Gilteritinib","Sorafenib",[35,29,36,37,32,38],"Acute Myeloid Leukemia","Allogeneic Hematopoietic Cell Transplantatio","Maintenance therapy","sorafeni","RECRUITING","2026-03-18",{"date":42,"type":43},"2026-03-20","ACTUAL",{"date":45,"type":22},"2026-05-01",{"date":47,"type":22},"2030-03-31",{"name":49,"class":50},"The First Affiliated Hospital of Soochow University","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100561655","a-clinical-study-of-sorafenib-combined-with-gefitinib-for-the-treatment-of-pnet-100561655","NCT06592989","A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of pNET","A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of Pancreatic Neuroendocrine Tumor Patients Who Have Progressed After Previous Treatment","Inclusion Criteria:\n\n1. Patients must have a full understanding of this study and voluntarily sign an informed consent form;\n2. Age ≥ 18 years old and age ≤ 80 years old;\n3. Patients with pancreatic neuroendocrine tumors diagnosed by histopathology or cytology, who have progressed after previous treatments such as SSA, targeted therapy, and chemotherapy (all grades of pancreatic neuroendocrine tumors and neuroendocrine cancers are allowed to be included);\n4. According to the criteria for evaluating the efficacy of solid tumors (RECIST V1.1), there should be at least one measurable lesion;\n5. At least 7 days have passed since the end of the last systemic treatment, and palliative radiotherapy for localized areas is allowed. It has been completed for more than 4 weeks;\n6. Expected survival time ≥ 12 weeks;\n7. Researchers estimate that patients can benefit from it;\n8. The patients have sufficient organ and bone marrow function;\n9. Male or female patients with fertility voluntarily use effective contraceptive methods, such as double barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study medication. All female patients will be considered to have fertility unless they have undergone natural menopause, artificial menopause, or sterilization surgery (such as hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation).\n\nExclusion Criteria:\n\n1. Other malignant tumors have been diagnosed in the past 5 years, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or effectively resected cervical carcinoma in situ, breast cancer;\n2. Simultaneously receiving other investigational drugs or approved or investigational anti-tumor treatments;\n3. Patients with contraindications to experimental drugs (such as active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension, III-IV grade heart failure, within 30 days after major surgery, severe liver and kidney dysfunction, etc.);\n4. The patient currently has any diseases or conditions that affect drug absorption, or the patient is unable to take oral medication;\n5. Confirmed allergy to any component of the investigational drug and\u002For its excipients;\n6. Pregnant (positive pregnancy test before medication) or breastfeeding women;\n7. Patients with large amounts of pleural effusion or ascites requiring drainage;\n8. Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory examination abnormalities. According to the researcher's judgment, it is suspected that the patient has a certain disease or condition that is not suitable for the use of the study drug (such as having seizures and requiring treatment), or that it will affect the interpretation of the study results, or put the patient in a high-risk situation;\n9. Have taken medication containing components of Hypericum perforatum within 3 weeks prior to the first study medication. Or have taken other strong inducers or inhibitors of CYP3A4 within the previous 2 weeks;\n10. According to the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study or are not suitable for inclusion, such as other serious concomitant diseases (such as severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, mental illness), serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples).","18 Years","80 Years",{"count":61,"type":22},20,"OBSERVATIONAL","The incidence rate of pancreatic neuroendocrine neoplasms (pNENs) is increasing year by year. According to the statistical results of the SEER (Surveillance, Epidemiology, and End Results) database, the incidence rate of pNENs increased from 0.27\u002F100000 to 1\u002F100000 from 2000 to 2016, with a median overall survival time of 68 months. The 5-year overall survival rates of localized, locally advanced, and metastatic pNENs were 83%, 67%, and 28%, respectively. pNENs are gradually gaining attention and importance from the medical community. The existing therapeutic drugs for neuroendocrine tumors include somatostatin analogues, recombinant human interferon injections, chemotherapy drugs, and molecular targeted drugs.\n\nAlthough these drugs can prolong patients' PFS to some extent, there is a common problem of low objective response rates. In recent years, sunitinib and everolimus have been approved for targeted therapy in patients with pancreatic neuroendocrine neoplasms , but their clinical efficacy is still limited. The study by Panzuto et al. showed that the median PFS for first-line treatment of advanced well differentiated pancreatic neuroendocrine neoplasms was 13.9 months, with an ORR of 14.9%. After imaging progression of the disease, the median PFS after second-line treatment was 15 months, and the ORR of only 5.5%. There is currently no effective treatment for patients with disease progression or drug resistance after undergoing existing treatment ways.\n\nTherefore, there is a huge clinical demand for the treatment of pNEN patients worldwide, and effective drugs are urgently needed to benefit these patients.\n\nOur previous research found that pathways in tumor were significantly affected in pNENs and liver metastases and EGFR tyrosine kinase inhibitor resistance and transcriptional dysregulation in tumor were unique to liver metastasis through KEGG pathway analysis; Meanwhile, GO Biological Processes analysis emphasizes those signaling pathways closely related to tyrosine phosphorylation, DNA repair, and cell cycle regulation, especially in liver metastases. Xiao et al. found that epidermal growth factor receptor (EGFR) was enriched in high glycosylation pNENs using RNA-seq. EGFR was expressed in 21.2% of pNENs using immunohistochemistry and associated with poor overall survival. Therefore, the study from Xiao et al. demonstrates that EGFR may be a potential therapeutic target for pNENs. This is consistent with our previous findings that the EGFR signaling pathway plays an important role in pNENs with liver metastases.\n\nDue to the heterogeneity and complexity of tumors, the efficacy of monotherapy or blocking a single signaling pathway may be limited or this treatment method may easily develop drug resistance. The existing anti-tumor targeted drugs block tumor angiogenesis by inhibiting vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF). Colony-stimulating factor 1 receptor (CSF1R) is an important signaling pathway associated with the survival and function of tumor associated macrophages (TAMs). Inhibiting CSF1R can regulate the activity of macrophages, improve the immune microenvironment, promote immune response, and activate the body's immune function. Sofantinib is a novel oral tyrosine kinase inhibitor which exerts dual effects of anti-tumor angiogenesis and immune regulation by targeting VEGFR, FGFR1, and CSF1R, resulting in synergistic anti-tumor activity. In December 2020 and June 2021, sorafenib was approved in China as a monotherapy for unresectable locally advanced or metastatic, well differentiated extrapancreatic and pancreatic neuroendocrine neoplasms.\n\nHowever, in a multicenter, single blind, open label, phase Ib\u002FII clinical trial, the objective response rate for pNENs patients was only 19%. There is currently no effective treatment available for patients with disease progression or drug resistance after undergoing existing treatment regimens. Therefore, there is an urgent need to seek new treatment methods to improve the therapeutic effect of pNENs. Based on our previous research results and relevant literature reports, we speculate that the combination of sorafenib and EGFR inhibitor gefitinib may improve the therapeutic effect of pNENs patients.",[65,33,66],"Pancreatic Neuroendocrine Neoplasm","Gefitinib","2025-01-09",{"date":69,"type":43},"2025-01-10",{"date":71,"type":43},"2024-09-30",{"date":73,"type":22},"2026-09-30",{"name":75,"class":50},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",1]