Using personalized vaccines to prevent recurrence in ovarian cancer patients after surgery

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

This study is testing whether personalized vaccines can help prevent ovarian cancer from coming back after surgery by monitoring specific markers in the blood.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT06341907 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to establish a technical system for monitoring circulating tumor DNA (ctDNA) in patients with postoperative epithelial ovarian cancer (EOC) to prevent recurrence. It combines conventional treatment protocols with personalized neoantigen vaccines tailored to individual patients' tumor profiles. The study will involve sequencing tumor tissue specimens to identify neoantigens, followed by adjuvant treatment and monitoring of various health indicators to evaluate effectiveness and safety. The goal is to improve survival outcomes for patients at risk of recurrence after surgery.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-70 with stage II, III, or IV epithelial ovarian cancer who have undergone surgery and have positive ctDNA MRD tests.

Not a fit: Patients with early-stage ovarian cancer or those who cannot provide sufficient tumor tissue samples may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrence in ovarian cancer patients post-surgery, leading to improved survival rates.

How similar studies have performed: Other studies have shown promise in using personalized vaccines for cancer treatment, but this specific approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Wenzhou, Zhejiang

• Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Ping Duan, Master — Second Affiliated Hospital of Wenzhou Medical University
• Study coordinator: Xinxin Zhang, Master

Conditions Epithelial Ovarian Cancer