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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen polypeptide vaccine | Biological | Completion of polypeptide neoantigen polypeptide vaccine (day 1, 4, 8, 15, 22, 54, and 84) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Index | Adverse Events; Serious Adverse Events;Drug-related Death; | every 3 months after operation up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxin Zhang, Master | Contact | +86 150 6781 0815 | zhxinxin1122@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping Duan, Master | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2024 |
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| Mar 13, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2024 | Mar 13, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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