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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zhxinxin1122@163.com
• Phone: +86 150 6781 0815

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

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• Whole-body metabolic activity as a predictor of chemotherapy response in epithelial ovarian cancer

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• Dual-target CAR-NK Cells for Peritoneal Cancers of the Ovary, Fallopian Tube, or Pseudoperitoneal Disease

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  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07617753

• Dual-Target CAR-NK Cells for Recurrent or Refractory Epithelial Ovarian Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.