Individualized Precision Treatment Based on Ovarian Cancer Organoid Model

Study Overview
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Brief Summary
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The research purpose of this study is to use organoid cultured from patients' own ovarian cancer tissues as models, screen potential clinical therapeutic drugs (such as paclitaxel, gemcitabine, etc.) in vitro, formulate individualized drug treatment plans for individual patient, and evaluate the clinical application value of organ like drug sensitivity technology.

Detailed Description
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Under the guidance of ultrasound, the lesions were punctured to obtain tumor cells; The cells were amplified and cultured by organ like culture method to establish ovarian cancer like organoid. The drug sensitivity tests of different drugs were carried out on similar organs. Number of drugs tested: 10 (paclitaxel, carboplatin, lobaplatin, doxorubicin, etc.); After the test is completed, sufficient chemotherapy for full course of treatment shall be carried out according to the drug sensitivity results; After chemotherapy, blood and imaging evaluation were performed; Collect the information of patients from initial treatment to the end of chemotherapy; Matching the corresponding number of patients with platinum resistant relapse who did not undergo organ like culture; At each end point, the evaluation and comparison were carried out and the research conclusions were drawn.

Official Title
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Chief Physician of Obstetrics and Gynecology Department of the First Affiliated Hospital of Xiamen University

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Device: Organoid culture


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients diagnosed as primary nonmucous epithelial ovarian cancer with stage III or above by previous pathological diagnosis; According to the relevant standards formulated by the World Health Organization (WHO) in 2014, measurable or assessable lesions are determined; platinum-resistant epithelial ovarian cancer that has received more than 2 lines of chemotherapy; There is no serious disease of important organs, and the patient can tolerate chemotherapy. Karnofsky score more than 60, and the expected survival period is more than half a year; The liver, kidney and bone marrow functions were good. Exclusion criteria Patients with other malignant tumors; Patients with nervous system diseases; Hepatitis B virus and human papilloma virus infection; Immune function defect or serious infection; Patients who cannot communicate effectively, disagree with the research requirements, and do not understand the research purpose.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platinum resistant ovarian cancer<br>Advanced-stage epithelial ovarian cancer (stage III or above) that has received more than 2 lines of chemotherapy and recurred within 6 months after the chemotherapy is stopped; | Device: Organoid culture<br>* Tumor like organ is a kind of organ cultured from tissues of tumor patients, which is a small tumor growing in a culture dish. Compared with the traditional two-dimensional culture system, the most important feature of this technological innovation is that it can directly use the patient's own tissue to culture organ like cells. At the same time, these organ like cells can well replicate some key characteristics of the primary tumor and retain the pathological form and biological mechanism of the patient's tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate | partial or complete remission ratio according to RECIST criteria | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer；Platinum-resistant；chemosensitivity