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NCT06341907RecruitingPhase 2/3

Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
10 (estimated)
First submitted
14 Mar 2024
Start date
1 Jan 2024
Primary completion date
31 Dec 2026
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
NCT number
NCT06341907

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 10
  • From 1 Jan 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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);
  • The patient is affected by drug abuse, clinical or psychological or social factors that make informed consent or research implementation affected;

Other illness

  • 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;
  • Subjects with immune deficiency diseases or autoimmune diseases;
  • People who may be allergic to immunotherapy;

Other

  • 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.

Who the study is looking for

  • 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);
  • 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 (AST) and alanine aminotransferase (ALT) ≤2× upper limit of normal value (ULN); Creatinine clearance ≥60 ml/min;
  • 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.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Second Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.