[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584387":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":36,"locations":46,"responsibleParty":61,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":26,"overallStatus":90,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Chemotherapy-Tolerant Patients)","EXPERIMENTAL","Postoperative evaluation will be conducted within 4-12 weeks after surgery, and patients without recurrence will be enrolled. For patients who are chemotherapy-tolerant (evaluated by investigators), adjuvant therapy is to commence within 6-12 weeks postoperatively, with the first day of treatment (D1) defined as the date of initial postoperative intervention. Postoperative treatment follows the:\n\n1.Gemcitabine + Capecitabine (GC) regimen+ Sintilimab: Gemcitabine: 1000 mg\u002Fm², intravenously on D1 and D8;Capecitabine: 1650-2000 mg\u002F(m²·day), divided into two daily oral doses from D1 to D14；Sintilimab (200 mg); Q3W for 8 cycles.2.Personalized mRNA injection (100 μg subcutaneously, Q3W) administered from D22±3.\n\nOn Day 43 ±3 days: The second efficacy assessment will be performed. Patients without disease progression will continue treatment. Patients with disease progression will transition to a second-line chemotherapy regimen (decided by investigators) combined with mRNA and Sintilimab.",[13,14,15],"Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection","Drug: Gemcitabine + Capecitabine","Drug: Sintilimab injection",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm B (Chemotherapy-Intolerant or Chemotherapy-Declined Patients)","Postoperative evaluation will be conducted within 4-12 weeks after surgery, and patients without recurrence will be enrolled. For patients who are Chemotherapy-Intolerant or Chemotherapy-Declined, postoperative treatment consists of Sintilimab (200 mg via intravenous infusion) administered Q3W for 8 cycles. On Day 22 ± 3 days, patients will initiate treatment with personalized mRNA injection at a dose of 100 μg administered subcutaneously Q3W, for a maximum of 9 doses.\n\nOn Day 43 ±3 days: The second efficacy assessment will be performed. Patients without disease progression will continue treatment. Patients with disease progression will transition to a second-line chemotherapy regimen (decided by investigators) combined with personalized mRNA injection (100 μg subcutaneously,Q3W) and Sintilimab (200 mg via intravenous infusion, Q3W).",[13,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","individualized anti-tumor new antigen iNeo-Vac-R01 injection","The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Neoantigen Therapeutics 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.",[9,17],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Gemcitabine + Capecitabine","Gemcitabine: 1000 mg\u002Fm², administered intravenously over 30 minutes on Day 1 and Day 8; Capecitabine: 1650-2000 mg\u002F(m²·day), divided into two daily oral doses from Day 1 to Day 14.\n\nTreatment cycles repeat every 3 weeks for 8 cycles, with the actual number of cycles determined by the investigator based on comprehensive evaluation of the patient's physical status, disease progression, and adverse reactions.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Sintilimab injection","Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks",[9,17],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Tingbo Liang, MD., PhD.","CONTACT","+8619941463683","liangtingbo@zju.edu.cn",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Yiwen Chen, MD.","+8615088682641","yiwenchen0705@126.com",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"First Affiliated Hospital of Zhejiang University Schlool of Medicine","Hangzhou","Zhejiang","China","CN",{"type":54,"coordinates":55},"Point",[56,57],120.16142,30.29365,{"lat":57,"lon":56},[60],{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":65,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","TingBo Liang","The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine","First Affiliated Hospital of Zhejiang University",[67],{"name":68,"class":69},"Hangzhou Neoantigen Therapeutics Co., Ltd.","INDUSTRY","100584387","phase-1-personalized-tumor-neoantigen-mrna-therapy-adjuvant-treatment-for-postoperative-pancreatic-cancer-100584387",false,"NCT06888674","Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.","Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy Combined with PD-1 Antibody and Chemotherapy As Adjuvant Treatment for Postoperative Pancreatic Cancer.","Inclusion Criteria:\n\n1. Pre-Screening Phase Inclusion Criteria (for Radical Surgery and Vaccine Preparation):\n\n   * Subjects meeting all of the following criteria will enter the pre-screening phase for radical surgery and vaccine preparation:\n   * Voluntarily sign the informed consent form (ICF);\n   * Age ≥18 years, regardless of gender;\n   * Diagnosed with resectable pancreatic cancer as assessed per the 2024 NCCN Clinical Practice Guidelines and willing to undergo radical surgery;\n   * ECOG Performance Status score of 0 or 1;\n   * Ability to obtain sufficient fresh tumor tissue samples for whole-exome sequencing (WES) and transcriptome sequencing analysis;\n   * Normal function of major organs (heart, liver, kidneys):\n   * Liver function: Total bilirubin ≤1.5×ULN; ALT\u002FAST ≤2.5×ULN;\n   * Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n   * Cardiac function: LVEF ≥50% by echocardiography;\n   * Contraception agreement: Fertile males and females of childbearing potential must agree to use effective contraception from signing the ICF until 6 months after the last dose of study treatment. Females of childbearing potential include premenopausal women and women ≤2 years postmenopausal;\n   * Ability to comply with the study protocol and follow-up procedures.\n2. Formal Screening Phase Inclusion Criteria (for Study Treatment Initiation):\n\n   * Subjects meeting all of the following criteria will enter the formal screening phase for study treatment:\n   * Voluntarily sign the informed consent form (ICF);\n   * Age ≥18 years, regardless of gender;\n   * Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) post-surgery;\n   * Completion of radical resection (R0 or R1) with no evidence of metastatic disease, malignant ascites, or pleural effusion on imaging 4-12 weeks postoperatively;\n   * ECOG Performance Status score:Cohort A: 0 or 1;Cohort B: 0-2;\n   * Normal function of major organs (heart, liver, kidneys):\n   * Contraception agreement: Same as pre-screening criteria;\n   * Ability to comply with the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from the study:\n\n* Serum CA 19-9 level \\>180 U\u002FmL within 21 days prior to initiating standard postoperative adjuvant therapy;\n* History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;\n* Concurrent immunosuppressive therapy, defined as regular use of immunosuppressive agents within 4 weeks prior to screening or during the study, including but not limited to:\n\n  1. Severe asthma requiring systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent);\n  2. Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus);\n  3. History of primary immunodeficiency;\n  4. Exceptions: Type 1 diabetes, autoimmune hypothyroidism managed with hormone replacement, vitiligo, or psoriasis not requiring systemic therapy;\n* Active bacterial\u002Ffungal infections requiring systemic treatment, or active\u002Flatent tuberculosis (confirmed by interferon-gamma release assay or tuberculin skin test);\n* Active viral infections:\n\n  1. HIV antibody-positive;\n  2. Syphilis (TP antibody-positive with RPR\u002FTRUST confirmation);\n  3. Active hepatitis C (HCV RNA-positive);\n  4. Active hepatitis B (HBsAg-positive and HBV DNA ≥2000 IU\u002FmL);\n* Acute viral infections:\n\n  1. Herpesvirus infection (unless resolved with crusting \\>4 weeks prior);\n  2. Respiratory viral infection (unless resolved \\>4 weeks prior);\n* Uncontrolled comorbidities:\n\n  1. Symptomatic congestive heart failure (NYHA Class III\u002FIV);\n  2. Unstable angina or arrhythmia requiring treatment;\n  3. Severe coronary\u002Fcerebrovascular disease (e.g., myocardial infarction within 6 months);\n  4. Other conditions deemed exclusionary by the investigator;\n* History of drug abuse, psychiatric disorders, or psychosocial factors impairing informed consent or protocol compliance;\n* History of severe hypersensitivity to vaccines, biologics, or any component of the study drug;\n* Pregnancy or lactation;\n* Other conditions judged by the investigator to preclude safe participation.","ALL","18 Years","75 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This study is a single-center, open-label clinical study to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimen as adjuvant treatment for postoperative resectable pancreatic cancer.",[89],"Pancreatic Cancer Resectable","NOT_YET_RECRUITING","2025-03-15",{"date":93,"type":94},"2025-03-21","ACTUAL",{"date":96,"type":82},"2025-04-01",{"date":98,"type":82},"2029-04-01",{"name":5,"class":6},1]