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Prevention study for Epithelial Ovarian Cancer
Official title Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC
ClinicalTrials.gov ID: NCT06341907
What this study is testing
What is Neoantigen polypeptide vaccine?
Neoantigen polypeptide vaccine is an investigational medicine, being studied as a potential treatment for epithelial ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Patients with stage II, III, and IV epithelial ovarian cancer who can be surgically resected and can provide sufficient tumor tissue samples...
- 18-70 years old;
- In the judgment of the researcher, be able to comply with the research protocol;
- Voluntarily join the study and sign the informed consent;
- Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L; Total...
You likely can't join if
- The patient has HIV infection, HBV infection, HCV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or...
- Patients with a history of bone marrow or organ transplantation;
- People with coagulation disorders;
- Gastrointestinal bleeding or gastrointestinal bleeding tendency;
- people with immune deficiency diseases or autoimmune diseases;
- Patients who have received other immunotherapy within 1 month (such as immunotherapy with checkpoint inhibitors, therapeutic antibodies, immune cell...
See the full eligibility criteria
- 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...
- 18-70 years old;
- In the judgment of the researcher, be able to comply with the research protocol;
- Voluntarily join the study and sign the informed consent;
- 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...
- Expected survival ≥ 3 months;
- The performance status of the Eastern Cancer Cooperation Group (ECOG) was 0 or 1.
- Postoperative ctDNA MRD test was positive, routine blood index was negative, imaging was negative.
- 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;
- Patients with a history of bone marrow or organ transplantation;
- People with coagulation disorders;
- Gastrointestinal bleeding or gastrointestinal bleeding tendency;
- people with immune deficiency diseases or autoimmune diseases;
- 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);
- People who may be allergic to immunotherapy;
- The patient is affected by drug abuse, clinical or psychological or social factors that make informed consent or research implementation affected;
- Pregnant and lactating women;
- Patients who are participating in or have participated in other clinical trials within 1 month;
- Any uncertainty affecting the patient's safety or compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.