[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643738":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":48,"slug":20,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ONVAX-01 + Anti-PD-1 Antibody + Chemotherapy","EXPERIMENTAL","Participants with pancreatic ductal adenocarcinoma will receive a combination therapy of peptide nanovaccine (ONVAX-01), anti-PD-1, and standard chemotherapy.\n\nTreatment Schema:\n\nInduction Phase: Participants receive ONVAX-01 and anti-PD-1 in combination with investigator-selected chemotherapy (either AG regimen or NALIRIFOX regimen) for 6-12 cycles.\n\nMaintenance Phase: Participants achieving clinical benefit (CR, PR, or SD) will continue treatment with ONVAX-01 and anti-PD-1.\n\nTreatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.",[13],"Drug: ONVAX-01 plus Anti-PD-1 and Chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ONVAX-01 plus Anti-PD-1 and Chemotherapy","The peptide nanovaccine (ONVAX-01) is administered via subcutaneous (SC) or intradermal (ID) injection, while the anti-PD-1 antibody and chemotherapy regimens are administered via intravenous (IV) infusion.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Zhong Wu","CONTACT","+8685422474","wuzhong0057@163.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":36,"coordinates":37},"Point",[38,39],104.06667,30.66667,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"85422474",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Zhen-Yu Ding","Professor","100643738",false,"NCT07637786","Peptide Nanovaccine (ONVAX-01) Plus Anti-PD-1 Antibody and Chemotherapy in Advanced Pancreatic Cancer","An Exploratory Clinical Study of Peptide Nanovaccine (ONVAX-01) and Anti-PD-1 Antibody Combined With Chemotherapy for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* • Age between 18 and 75 years (inclusive).\n\n  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Histologically confirmed, KRAS-mutated, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).\n  * Documented disease progression after at least one prior line of systemic therapy.\n  * Estimated life expectancy of ≥ 12 weeks.\n  * At least one measurable objective tumor lesion according to RECIST v1.1. The maximum diameter must be ≥ 1 cm by spiral CT, or ≥ 2 cm by standard CT or MRI; imaging must be performed within 28 days prior to enrollment.\n  * Adequate bone marrow and organ function, defined as follows (without the use of hematopoietic growth factors or blood transfusions within 7 days prior to testing):\n\n    * Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 75 × 10\\^9\u002FL, and hemoglobin ≥ 90 g\u002FL.\n    * Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n    * Renal: Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n    * Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.\n    * Cardiac: Normal electrocardiogram (ECG) or abnormal ECG deemed clinically insignificant by the investigator.\n    * Urinalysis: Urine protein \\\u003C 2+; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be \\\u003C 1.0 g.\n  * Participants of childbearing potential must agree to use highly effective contraceptive measures from study entry throughout the study period.\n  * Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have received at least 14 days of continuous antiviral therapy prior to the first study dose. HBV DNA titer must be ≤ 500 IU\u002FmL (or 2500 copies\u002FmL) and HCV RNA must be below the lower limit of detection. Participants must be willing to continue effective antiviral therapy during the study.\n\nExclusion Criteria:\n\n* • Receipt of anti-tumor chemotherapy, radiotherapy, or immunotherapy within 2 weeks prior to the first dose of the study vaccine.\n\n  * History of other malignancies, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, non-muscle invasive bladder cancer (Ta and TIS), or other malignancies curatively treated at least 5 years prior to enrollment.\n  * Uncontrolled concomitant diseases, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.\n  * Prior treatment with any antibody or drug targeting T-cell co-regulatory proteins (immune checkpoints), such as anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 antibodies.\n  * Human Immunodeficiency Virus (HIV) infection, or active uncontrolled HBV (HBV DNA ≥ 500 IU\u002FmL) or HCV infection.\n  * Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or any other medical conditions deemed unsuitable for enrollment by the investigator.\n  * Active autoimmune disease, primary or secondary immunodeficiency, or current treatment with immunosuppressive medications.\n  * Pregnant or lactating women.\n  * Receipt of any prophylactic vaccines for infectious diseases within 4 weeks prior to the first dose, or planned vaccination during the study up to 8 weeks after the last dose.\n  * History of severe allergic reactions to prior prophylactic vaccines.\n  * Known allergy or hypersensitivity to the investigational drugs or any of their excipients.\n  * History of substance abuse, or any clinical, psychological, or social factors that would preclude the administration of immunotherapy.\n  * Significant weight loss (≥ 10% of body weight) within 6 weeks prior to enrollment.\n  * Any other condition or uncertainty that, in the investigator's judgment, could compromise patient safety or compliance with the study protocol.","ALL","18 Years","75 Years",{"count":58,"type":59},9,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","The goal of this clinical trial is to evaluate the safety and preliminary effectiveness of a new combination therapy in patients with advanced pancreatic cancer.\n\nThe main questions it aims to answer are:\n\n1. Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?\n2. Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?\n\nParticipants will be asked to:\n\n1. Receive doses of the peptide nanovaccine (ONVAX-01).\n2. Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.\n3. Undergo regular physical exams, blood tests, and imaging scans (such as CT or MRI) to monitor their health and the tumor's response to the treatment.",[65],"Advanced Pancreatic Adenocarcinoma",[67,68,69,70],"Advanced pancreatic adenocarcinoma","Anti-PD-1 Antibody","Peptide Nanovaccine","Chemotherapy","NOT_YET_RECRUITING","2026-06-09",{"date":74,"type":75},"2026-06-10","ACTUAL",{"date":77,"type":59},"2026-06-20",{"date":79,"type":59},"2029-09-01",{"name":5,"class":6},1]