The Culture of Advanced or Recurrent Ovarian Cancer Organoids and Drug Screening

Recruiting

• Conditions: Ovarian Neoplasms

• Registration Number: NCT05290961
• Lead Sponsor: Chongqing University Cancer Hospital

Brief Summary

Most ovarian cancer will relapse after standard therapy. Patients with recurrent ovarian cancer are resistant to platinum. Due to the high heterogeneity between ovarian cancer, individual precise therapy is of great importance. The study will establish ovarian cancer organoids, whose original tissues from the patients with advanced or recurrent ovarian cancer, their tumors cannot be excised completely. The organoids will be identified at the histopathological level and gene level for evaluating the consistency with the original tumor tissue. The drug's sensitivity and specificity are detected through the organoids model. Compared with the clinical efficiency of the actual drug regimen, the efficacy of the organoid drug screening model can be assessed. The aim is to construct a precise drug screening platform for advanced and recurrent ovarian cancer patients and innovate drug research and development.

Detailed Description

This trial is a single-arm and prospective observational study. The subjects are the advanced or recurrent ovarian cancer patients, who are planned to undergo surgery, but the neoplastic lesions can't be excised thoroughly. They voluntarily participate in the study and sign an informed consent form. General information will be collected, including name, age, address and contact information. Comprehensive physical examination will be performed. Ovarian cancer tumor markers and imaging examinations (gastroenterostomy, ultrasound / CT / MRI or PET / CT) should be taken within 4 weeks before treatment. Histopathological and genetic characteristics were analyzed in organoids and paired primary tumors to confirm whether organoids faithfully recapitulated the original tumor tissues. The sensitivity and specificity of first-line and second-line drugs from NCCN guidelines will be detected on the organoids. Ovarian cancer (CA125、HE4、CEA、CA-199) markers will be tested within one week. After the treatment period of 3 and 6 months, the short-term efficacy will be evaluated according to the efficacy evaluation standard of solid tumor (Recist1.1) (the window period is 4 weeks). Biochemical indexes, adverse reactions, and prognosis (PFS, OS) will be followed. Compared with the efficacy of the actual clinical regimen, the potency of organoid as a drug screening model will be assessed.

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-12
• Study First Posted: 2022-03-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Patients voluntarily participated in the study and signed informed consent;
2. The tumour cannot be excised thoroughly by surgery;
3. ECOG score ≤ 2;
4. Expected survival >6 months;
5. Blood routine test: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L;
6. Both serum ALT and serum AST ≤ 2 × ULN； blood creatinine ≤ 1.5 × ULN;
7. Unpregnant women (negative HCG) received contraception in the study;
8. Good compliance is judged by researchers.

Exclusion Criteria

1. Active or the uncontrol serious infections;
2. Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment;
3. A history of immune deficiency, including HIV positive or other acquired congenital immune deficiency diseases;
4. Chronic renal insufficiency and renal failure;
5. Myocardial infarction, severe arrhythmia and congestive heart failure (≥ grade 2 according to NYHA classification);
6. Autoimmune diseases, including systemic lupus erythematosus;
7. Patients take drugs that damage liver and kidney function for other complications, such as tuberculosis;
8. Patients cannot understand the experimental contents and refuse to sign the informed consent form;
9. Other concomitant serious diseases harm the health of patients or interfere with the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	2 years	Progression-free survival means the duration from enrollment to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years	Overall survival means the duration from enrollment to death due to any cause. The last follow-up time is calculated as the death time for subjects who lost follow-up.

Trial Locations

Locations (1)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China