Application of MRD Combined With Personalized Vaccine in the Adjuvant Treatment of Postoperative Recurrence Prevention of Epithelial Ovarian Cancer

SAHoWMU-CR2024-07-107

The goal of this clinical trial is as follows:(1) Establish a clinical technical system for ctDNA dynamic monitoring of MRD in postoperative EOC patients, providing a new technical means for postoperative recurrence prevention and monitoring of EOC patients.(2) Establish a clinical technical system for adjuvant treatment of postoperative recurrence prevention for EOC patients with conventional protocols combined with personalized vaccines, so as to provide a new treatment method for postoperative recurrence prevention for EOC patients, with a view to obtaining a better survival prognosis.(3) To establish and improve the prediction process of Neoantigen for ovarian cancer and the in vitro evaluation system of the effectiveness of neoantigen vaccine, achieve independent innovation of tumor neoantigen vaccine treatment technology, and cultivate a group of technical forces to master the development of modern tumor vaccine drugs.(4) The new technology system has been promoted and applied in 5 hospitals in the province.

2024-01-01

2026-12-31

2026-12-31

Recruiting

Early phase I

10

Inclusion Criteria: 1. Patients with stage II, III, and IV epithelial ovarian cancer who can be surgically resected and can provide sufficient tumor tissue samples, including paraffin-embedded (FFPE) blocks or fresh sections of formalin-fixed tissue within six months (approved by the organizer only); 2. 18-70 years old; 3. In the judgment of the researcher, be able to comply with the research protocol; 4. Voluntarily join the study and sign the informed consent; 5. Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L; Total bilirubin ≤2× upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2× upper limit of normal value (ULN); Creatinine clearance ≥60 ml/min; 6. Expected survival ≥ 3 months; 7. The performance status of the Eastern Cancer Cooperation Group (ECOG) was 0 or 1. 8. Postoperative ctDNA MRD test was positive, routine blood index was negative, imaging was negative. Exclusion Criteria: 1. The patient has HIV infection, HBV infection, HCV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other disease that the investigator considers ineligible; 2. Patients with a history of bone marrow or organ transplantation; 3. People with coagulation disorders; 4. Gastrointestinal bleeding or gastrointestinal bleeding tendency; 5. Subjects with immune deficiency diseases or autoimmune diseases; 6. Patients who have received other immunotherapy within 1 month (such as immunotherapy with checkpoint inhibitors, therapeutic antibodies, immune cell therapy, and immune system modulator therapy); 7. People who may be allergic to immunotherapy; 8. The patient is affected by drug abuse, clinical or psychological or social factors that make informed consent or research implementation affected; 9. Pregnant and lactating women; 10. Patients who are participating in or have participated in other clinical trials within 1 month; 11. Any uncertainty affecting the patient's safety or compliance.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2024-04-02