Actively Recruiting
Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2024-04-02
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage II, III, or IV epithelial ovarian cancer who can have surgery and provide tumor tissue samples within 6 months
- Aged between 18 and 70 years
- Able to follow the study protocol as judged by the researcher
- Willing to participate and sign informed consent
- Meet blood test requirements: neutrophils ≥1.5×10⁹/L; hemoglobin ≥10.0 g/dL; platelets ≥100×10⁹/L; total bilirubin ≤2× upper limit of normal; AST and ALT ≤2× upper limit of normal; creatinine clearance ≥60 ml/min
- Expected survival of at least 3 months
- Eastern Cancer Cooperation Group (ECOG) performance status of 0 or 1
- Positive postoperative ctDNA MRD test with normal routine blood and imaging results
You will not qualify if you...
- Infection with HIV, HBV, or HCV; uncontrolled coronary artery disease or asthma; uncontrolled cerebrovascular disease; or other conditions considered unsuitable by the investigator
- History of bone marrow or organ transplantation
- Coagulation disorders
- Gastrointestinal bleeding or tendency to bleed
- Immune deficiency or autoimmune diseases
- Received other immunotherapy within 1 month (including checkpoint inhibitors, antibodies, immune cell therapy, or immune modulator therapy)
- Possible allergy to immunotherapy
- Drug abuse or clinical, psychological, or social factors affecting consent or study participation
- Pregnant or breastfeeding women
- Participation in other clinical trials within 1 month
- Any other condition that may affect patient safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xinxin Zhang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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