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

NCT06341907 | Recruiting Phase 2

• 1 other identifier: SAHoWMU-CR2024-07-107
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• ORR

  Objective Response Rate

  every 3 months after operation up to 24 months

• PFS

  Progression Free Survival

  every 3 months after operation up to 24 months

• OS

  Overall Survival

  every 3 months after operation up to 24 months

• CA 125

  Carbohydrate antigen 125

  every 3 months after operation up to 24 months

Secondary Outcomes (1)

• Safety Index

  every 3 months after operation up to 24 months

Study Arms (1)

Neoantigen polypeptide vaccine

EXPERIMENTAL

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

Interventions

Neoantigen polypeptide vaccine BIOLOGICAL

Completion of polypeptide neoantigen polypeptide vaccine (day 1, 4, 8, 15, 22, 54, and 84)

Neoantigen polypeptide vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Ping Duan, Master

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinxin Zhang, Master

CONTACT

+86 150 6781 0815; zhxinxin1122@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)