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

NCT05290961UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Chongqing University Cancer Hospital

Enrollment

30

Start Date

2022-03-09

Completion Date

2024-12-31

Study Type

OBSERVATIONAL

Official Title

Drug Response in Patient-derived Organoids Models of Advanced or Recurrent Ovarian Cancer, an Exploratory Research

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Progression-free Survival

Progression-free survival means the duration from enrollment to disease progression or death.

Time frame: 2 years

Secondary Outcomes

Overall survival

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.

Time frame: 2 years

Locations

Chongqing University Cancer Hospital, Chongqing, China