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

March 27, 2024 updated by: Second Affiliated Hospital of Wenzhou Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoantigen polypeptide vaccine
Each patient synthesized 5 to 20 neoantigen peptides and was injected with 1 to 4 injections of 1ml polypeptide-poly-ICLC mixture each time. The first round of immunization was administered subcutaneously on days 1, 4, 8, 15, and 22, and the second round of immunization was administered on days 54 and 84
Biological: Neoantigen polypeptide vaccine
Completion of polypeptide neoantigen polypeptide vaccine (day 1, 4, 8, 15, 22, 54, and 84)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: every 3 months after operation up to 24 months
Objective Response Rate
every 3 months after operation up to 24 months
PFS
Time Frame: every 3 months after operation up to 24 months
Progression Free Survival
every 3 months after operation up to 24 months
OS
Time Frame: every 3 months after operation up to 24 months
Overall Survival
every 3 months after operation up to 24 months
CA 125
Time Frame: every 3 months after operation up to 24 months
Carbohydrate antigen 125
every 3 months after operation up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Index
Time Frame: every 3 months after operation up to 24 months
Adverse Events; Serious Adverse Events;Drug-related Death;
every 3 months after operation up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Investigators

  • Principal Investigator: Ping Duan, Master, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2024-07-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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