Clinical trial NCT05813509: Individualized Precision Treatment Based on Ovarian Cancer Organoid Model
Official title: Chief Physician of Obstetrics and Gynecology Department of the First Affiliated Hospital of Xiamen University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Keywords: Ovarian cancer；Platinum-resistant；chemosensitivity
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Objective remission rate
timeFrame: 6 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: