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Application of MRD combined with personalized immunomodulatory diagnosis and treatment technology in the adjuvant treatment of postoperative recurrence prevention of epithelial ovarian cancer

Application of MRD combined with personalized immunomodulatory diagnosis and treatment technology in the adjuvant treatment of postoperative recurrence prevention of epithelial ovarian cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082936
Enrollment
Unknown
Registered
2024-04-11
Start date
2024-04-11
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial ovarian cancer

Interventions

Test group:Neonatal antigen polypeptide immunomodulator

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily join the study and sign the informed consent; 2.18-70 years old; 3. In the judgment of the researcher, be able to comply with the research protocol; 4. 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); 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

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; 6.1 Patients who have received other immunotherapy within the last 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.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;Progression Free Survival;Overall Survival;immune indexes;Minimal Residual Disease,MRD;

Secondary

MeasureTime frame
Safety Index;

Countries

China

Contacts

Public ContactPing Duan

Second Affiliated Hospital of Wenzhou Medical University

dppddpp@126.com+86 135 8743 0406

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026