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Trial Title:
Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC
NCT ID:
NCT06341907
Condition:
Epithelial Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Neoantigen polypeptide vaccine
Description:
Completion of polypeptide neoantigen polypeptide vaccine (day 1, 4, 8, 15, 22, 54, and
84)
Arm group label:
Neoantigen polypeptide vaccine
Summary:
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.
Detailed description:
Establish a clinical technology system for the application of conventional protocol
combined with personalized immune regulation diagnosis and treatment technology in the
adjuvant treatment of MRD-positive patients after EOC surgery: Enroll MRD-positive
patients, conduct tumor tissue specimen sequencing, analyze neoantigens, prepare
personalized immune regulation diagnosis and treatment technology, and conduct adjuvant
treatment for recurrence prevention and treatment with conventional protocol combined
with personalized immune regulation diagnosis and treatment technology. Blood routine,
biochemical, immunological, tumor indicators (CA125, HE4, CEA, CA199, etc.), imaging
examinations (CT, PET-CT, MRI and ultrasound examinations of the resection site of the
primary lesion or metastasis) and survival time (PFS, OS) of the patients were followed
up after treatment to evaluate their effectiveness and safety. To analyze the advantages
of routine regimen combined with personalized immunomodulatory diagnosis and treatment
technology for adjuvant therapy for recurrence prevention in MRD positive patients after
EOC.
The new technology system has been promoted and applied in 5 hospitals in the province:
it is evaluated and validated by carrying out prospective multi-center clinical studies
to guide the continuous optimization of clinical treatment strategies.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinxin Zhang
Phone:
+86 150 6781 0815
Email:
zhxinxin1122@163.com
Start date:
January 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Second Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341907
