[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-neuroendocrine-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-neuroendocrine-neoplasm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,68,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100531612","phase-2-temozolomide-and-survivin-long-peptide-vaccine-survaxm-for-the-treatment-of-patients-with-progressing-metastatic-neuroendocrine-carcinomas-100531612",false,"NCT06202066","Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas","A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have a Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (i.e. the patient must be able to care for himself\u002F herself with occasional help from others)\n* Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\\>20% (well-differentiated G3 NETs) or neuroendocrine carcinoma of any origin excluding small cell lung carcinoma\n* Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on two CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical)\n* Patients must have failed at least one prior systemic therapy\n* Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment\n* Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (obtained within 14 days prior to enrollment)\n* Platelets ≥ 100 x 10\\^9\u002FL (obtained within 14 days prior to enrollment)\n* Hemoglobin (Hgb) \\> 9g\u002FdL (obtained within 14 days prior to enrollment)\n* Plasma total bilirubin: ≤ 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 x ULN (obtained within 14 days prior to enrollment)\n* Creatinine clearance ≥ 60 mL\u002Fmin (per Cockroft-Gault equation) (obtained within 14 days prior to enrollment)\n* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \\[LMW\\] heparin) must meet the following criteria:\n\n  * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion)\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it\n* Has received prior treatment with SurVaxM\n* Received an investigational agent within 30 days prior to enrollment\n* Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bradycardia, tachycardia or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements and, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety\n* Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study\n* Known history of an autoimmune disorder\n* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness\n* Systemic corticosteroid therapy \\> 2mg of dexamethasone or equivalent per day at study entry\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug\n* Patients with Hepatitis B or Hepatitis C may be included if there are adequately controlled viral titers and no drug-drug interactions, testing not required","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase IIa trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67\u002FM57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.",[26,27,28,29],"Digestive System Neuroendocrine Neoplasm","Lung Neuroendocrine Neoplasm","Malignant Solid Neoplasm","Pancreatic Neuroendocrine Neoplasm","RECRUITING","2026-05-27",{"date":33,"type":34},"2026-05-28","ACTUAL",{"date":36,"type":20},"2026-07-15",{"date":38,"type":20},"2028-10-15",{"name":40,"class":41},"Roswell Park Cancer Institute","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100496588","genetic-predisposition-testing-program-for-pancreatic-neuroendocrine-neoplasms-100496588","NCT05746182","Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms","PanNEN","Inclusion Criteria:\n\n1. Histologically confirmed PanNEN.\n\n   a. The diagnostic biopsy may have been taken from any site (primary or metastatic).\n2. New and existing PanNEN participants will be eligible (any grade, any stage, any age \\> 18 years).\n3. Participants willing and able to comply with the study procedures.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. For participants who have not had prior testing with a dedicated germline pane of at least 80 genes:\n\n   1. Inability to speak\u002Fread a language supported by the germline testing station (GTS). The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic).\n   2. Active hematologic malignancy.\n   3. History of allogenic bone marrow transplant or stem cell transplant.",{"count":51,"type":20},300,"OBSERVATIONAL","This is a prospective observational multi-center pilot study of germline testing for participants receiving care at University of California participating locations with a new or existing diagnosis of Pancreatic Neuroendocrine Neoplasms (PanNEN). This protocol is an extension of existing Genetic Testing Station efforts at University of California, San Francisco (UCSF)",[29],[56,57],"Genetic Assay","Biomarkers","2026-01-22",{"date":60,"type":34},"2026-01-26",{"date":62,"type":34},"2023-04-07",{"date":64,"type":20},"2026-12-31",{"name":66,"class":41},"University of California, San Francisco",3,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":42},"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).","80 Years",{"count":77,"type":20},20,"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.",[29,80,81],"Sorafenib","Gefitinib","2025-01-09",{"date":84,"type":34},"2025-01-10",{"date":86,"type":34},"2024-09-30",{"date":88,"type":20},"2026-09-30",{"name":90,"class":41},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":42},"100463575","phase-2-nimotuzumab-in-egfr-highly-expressed-pancreatic-neuroendocrine-neoplasms-100463575","NCT05316480","Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms","Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms","Inclusion Criteria:\n\n1. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with well and moderately differentiated with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.\n2. Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.\n3. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.\n4. Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.\n5. Male or female, 18 years of age or older.\n6. ECOG performance status less than 2.\n7. Life expectancy greater than 12 weeks.\n8. The definitions of minimum adequacy for organ function required prior to study entry are as follows.\n\n   Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \\\u003C 2.5 x upper limit of normal (ULN), or AST and ALT \\\u003C 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin \\\u003C 1.5 x ULN Serum albumin \\> 3.0 g\u002FdL Absolute neutrophil count (ANC) \\> 1500\u002FL Hemoglobin \\> 9.0 g\u002FdL Creatinin clearance \\\u003C 40 mL\u002Fmin\n9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.\n10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Active second primary malignancy or history of second primary malignancy.\n2. Current treatment on another clinical trial.\n3. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.\n4. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.\n5. Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine neoplasms.\n6. Patients who are unwilling or unable to comply with study procedures.\n7. Prior targeted treatment on EGFR.\n8. Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection.",{"count":99,"type":20},42,[23],"The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.",[29],[104,105,29],"EGFR","nimotuzumab","NOT_YET_RECRUITING","2022-04-04",{"date":109,"type":34},"2022-04-07",{"date":111,"type":20},"2022-05-01",{"date":113,"type":20},"2026-12-30",{"name":115,"class":41},"Fudan University"]