Individualized Precision Treatment Based on Ovarian Cancer Organoid Model

Xiamen University

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Device: Organoid culture

Study type: Interventional

Funder types: Other

Identifiers

NCT05813509

XMYY-2022KY110

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Patients diagnosed as primary nonmucous epithelial ovarian cancer with stage III or above by previous pathological diagnosis;
2. According to the relevant standards formulated by the World Health Organization (WHO) in 2014, measurable or assessable lesions are determined;
3. platinum-resistant epithelial ovarian cancer that has received more than 2 lines of chemotherapy;
4. 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;
5. The liver, kidney and bone marrow functions were good.

Exclusion criteria

1. Patients with other malignant tumors;
2. Patients with nervous system diseases;
3. Hepatitis B virus and human papilloma virus infection;
4. Immune function defect or serious infection;
5. Patients who cannot communicate effectively, disagree with the research requirements, and do not understand the research purpose.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Platinum resistant ovarian cancer

Experimental group

Description:

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;

Treatment:

Device: Organoid culture