[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584385":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":32,"locations":42,"responsibleParty":58,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":22,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":22,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":22,"overallStatus":88,"whyStopped":22,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","On D1 patients start the mFOLFIRINOX every 2 weeks, and the actual number of cycles of mFOLFIRINOX will be determined by the investigators according on the patients' physical condition, disease progression, adverse effects; on the same day, started Sintilimab, 200mg, intravenous infusion, every 3 weeks; On D43 ± 3, the first efficacy assessment will be conducted. Patient with no disease progression, will continue the above treatment (mFOLFIRINOX Q2W + Sintilimab Q3W + individualized neoantigen mRNA injection Q3W); if disease progression, the patient will receive the second-line chemotherapy regimen (decided by investigators)+ Sintilimab Q3W + individualized neoantigen mRNA injection Q3W. Patients will receive efficacy assessment every 6 weeks.",[13,14,15],"Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection","Drug: mFOLFIRINOX Treatment Regimen","Drug: Sintilimab injection",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","individualized anti-tumor new antigen iNeo-Vac-R01 injection","The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","mFOLFIRINOX Treatment Regimen","continuous intravenous infusion of fluorouracil 2400mg \u002F m², for 46 hours, leucovorin 400mg \u002F m², irinotecan 135mg \u002F m², and oxaliplatin 68mg \u002F m², every 2 weeks",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Sintilimab injection","Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},"Tingbo Liang, MD., PhD.","CONTACT","+8619941463683","liangtingbo@zju.edu.cn",{"name":39,"role":35,"phone":40,"phoneExt":22,"email":41},"Yiwen Chen, MD.","+8615088682641","yiwenchen0705@126.com",[43],{"facility":44,"status":22,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"First Affiliated Hospital of Zhejiang University Schlool of Medicine","Hangzhou","Zhejiang","31000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.16142,30.29365,{"lat":54,"lon":53},[57],{"name":39,"role":35,"phone":40,"phoneExt":22,"email":41},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","TingBo Liang","The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine","First Affiliated Hospital of Zhejiang University",[64],{"name":65,"class":66},"Hangzhou Neoantigen Therapeutics Co., Ltd.","INDUSTRY","100584385","phase-1-personalized-tumor-neoantigen-mrna-therapy-for-advanced-pancreatic-cancer-100584385",false,"NCT06888648","Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.","Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.","Inclusion Criteria:\n\n(1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study:\n\n1. Voluntary signing of the informed consent form;\n2. Age: 18 and 75 years old, male or female;\n3. Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;\n4. No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.\n5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;\n6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1);\n7. Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis;\n8. Main organ function of heart, liver and kidney is normal:\n9. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause;\n10. Ability to follow the study protocol and follow-up procedures.\n\n(2) Subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process:\n\n1. Voluntary signing of the informed consent form;\n2. Age: 18 and 75 years old, male or female;\n3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology);\n4. No systemic treatment or gemcitabine-based first-line chemotherapy.\n5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;\n6. Main organ function of heart, liver and kidney is normal:\n7. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause;\n8. Ability to follow the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\nSubjects will be excluded from this study if they meet any of the following criteria:\n\n1. Pancreatic cancer has central nervous system metastasis or meningeal metastasis;\n2. At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;\n3. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;\n4. Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;\n5. Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis;\n6. Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B;\n7. Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks);\n8. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator;\n9. Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness;\n10. Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator.\n11. Women born during pregnancy or lactation;\n12. The investigator is not fit for enrollment or may not complete the trial for other reasons.","ALL","18 Years","75 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE1","PHASE2","This study is a single-arm phase I\u002FII clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.",[86,87],"Pancreatic Cancer Metastatic","Pancreatic Cancer Non-resectable","NOT_YET_RECRUITING","2025-03-15",{"date":91,"type":92},"2025-03-21","ACTUAL",{"date":94,"type":79},"2025-04-01",{"date":96,"type":79},"2028-04-01",{"name":5,"class":6},1]