Ovarian cancer
Conditions
Interventions
Experimental group:NeoOVIV vaccine
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged >=18 years and =100 mg (collected on the day of surgery and immediately placed in RNA preservation solution); or 2) Formalin-fixed paraffin-embedded (FFPE) tissue >=5 sections (5 µm thickness per section, tumor cell proportion >=30%, with no significant necrosis); (4) Verified by whole-exome sequencing (WES) and RNA sequencing, presence of >=5 "usable neoantigens" (defined as: HLA binding affinity IC50 =1); 3. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), postoperative pelvic enhanced MRI/CT shows no visible residual lesions (R2), and metastases to the lungs, liver, or bone are excluded; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1 (0: fully active, no restriction in daily activities; 1: capable of light physical activity, without significant fatigue or shortness of breath), with an expected survival of >=1 year; 5. Major organ functions are satisfactory, meaning that within 14 days prior to enrollment, the relevant test indicators meet the following requirements (during this period, no blood transfusion or blood products, no use of hematopoietic growth factors, no use of albumin or blood products): - Routine blood tests: Hemoglobin >= 90 g/L; neutrophil count >= 1.5×10^9/L; platelet count >= 100×10^9/L; - Biochemical tests: Total bilirubin = 50 mL/min; - Endocrine tests: Thyroid-stimulating hormone (TSH), free T3, and free T4 within normal reference ranges; - Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) <= 1.2×ULN; 6. Women of childbearing age must have a negative serum ß-HCG test before enrollment and agree to use effective contraception (such as condoms or intrauterine devices) during the trial period (from first dose to 6 months after the last dose); 7. Good compliance, with the patient and family agreeing to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with histopathologically confirmed non-epithelial ovarian cancer, including ovarian germ cell tumors (e.g., teratoma, yolk sac tumor), sex cord-stromal tumors (e.g., granulosa cell tumor), and metastatic ovarian tumors (e.g., Krukenberg tumor metastatic to the ovary from the gastrointestinal tract); 2.Patients with R2 resection (macroscopically visible residual tumor) at the surgical margin after cytoreductive surgery (CRS), or postoperative imaging (contrast-enhanced pelvic MRI/CT, chest CT) indicating distant metastasis (e.g., lung, liver, or brain metastasis), or FIGO Stage IV disease; 3.Prior receipt of any cancer vaccine therapy (e.g., peptide vaccines, DNA vaccines, other mRNA vaccines); or prior use of immune checkpoint inhibitors (ICIs, e.g., anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies) with the time from the last dose administration to enrollment = 7 days), enteric fistula (requiring surgical repair), massive hemorrhage (requiring blood transfusion >= 400 mL within 24 hours), and severe adhesive intestinal obstruction (requiring gastrointestinal decompression for >= 3 days); 5.Presence of active autoimmune disease, or a prior diagnosis of autoimmune disease that currently requires long-term (>= 2 weeks) use of immunosuppressive agents for disease control, including but not limited to: rheumatoid arthritis (RA, requiring prednisone >= 10 mg/day or equivalent dose of other immunosuppressive agents), systemic lupus erythematosus (SLE, requiring hydroxychloroquine combined with glucocorticoid therapy), ulcerative colitis (with a history of acute exacerbation within the past 1 year), multiple sclerosis (MS, with a history of relapse within the past 2 years), and autoimmune thyroiditis (currently requiring high-dose levothyroxine > 150 µg/day for disease control); 6.Presence of active infection within 1 month prior to enrollment, including but not limited to: Bacterial infections: such as pneumonia (requiring intravenous antibiotics), pyelonephritis (positive urine culture accompanied by fever); Viral infections: positive HBV surface antigen (HBsAg) with HBV DNA >= 1×10^3 IU/mL (without receiving antiviral therapy); positive HCV RNA (without receiving direct-acting antiviral agents [DAAs] or still positive after treatment); positive HIV antibody; acute varicella-zoster virus (VZV) or cytomegalovirus (CMV) infection (accompanied by fever or organ involvement); Fungal infections: such as pulmonary candidiasis, aspergillosis (indicated by imaging and positive fungal culture); 7.History of or current severe organ dysfunction: Cardiovascular system: acute myocardial infarction, unstable angina pectoris, heart failure (New York Heart Association [NYHA] classification >= Grade II), severe arrhythmia (e.g., ventricular tachycardia requiring pharmacological control) occurring within the past 6 months; or uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure = 100 mmHg that cannot be controlled despite antihypertensive therapy); Respiratory system: acute exacerbation of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis (indicated by CT with forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] < 70% on pulmonary function test), active pulmonary tuberculosis (posi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS);Vaccine Manufacturing Time;Immunogenicity assessment; | — |
Countries
China
Contacts
Public ContactXuelei Ma
West China Hospital of Sichuan University
Outcome results
None listed