Individualized Precision Treatment Based on Ovarian Cancer Organoid Model

NCT05813509 | Unknown

• 1 other identifier: XMYY-2022KY110
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer；Platinum-resistant；chemosensitivity

Outcome Measures

Primary Outcomes (1)

• Objective remission rate

  partial or complete remission ratio according to RECIST criteria

  6 months

Secondary Outcomes (1)

• Progression free survival

  3 years

Study Arms (1)

Platinum resistant ovarian cancer

EXPERIMENTAL

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

Interventions

Organoid culture DEVICE

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

Platinum resistant ovarian cancer

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

JianFa Lan, Doctor

CONTACT

18810535017; 407136123@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 14, 2023

Record last verified: 2022-12

Locations

CN (1)