Drug Response in Patient-derived Organoids Models of Advanced or Recurrent Ovarian Cancer, an Exploratory Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participated in the study and signed informed consent;
- •The tumour cannot be excised thoroughly by surgery;
- •ECOG score ≤ 2;
- •Expected survival >6 months;
- •Blood routine test: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L;
- •Both serum ALT and serum AST ≤ 2 × ULN； blood creatinine ≤ 1.5 × ULN;
- •Unpregnant women (negative HCG) received contraception in the study;
- •Good compliance is judged by researchers.
排除标准
- •Active or the uncontrol serious infections;
- •Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment;
- •A history of immune deficiency, including HIV positive or other acquired congenital immune deficiency diseases;
- •Chronic renal insufficiency and renal failure;
- •Myocardial infarction, severe arrhythmia and congestive heart failure (≥ grade 2 according to NYHA classification);
- •Autoimmune diseases, including systemic lupus erythematosus;
- •Patients take drugs that damage liver and kidney function for other complications, such as tuberculosis;
- •Patients cannot understand the experimental contents and refuse to sign the informed consent form;
- •Other concomitant serious diseases harm the health of patients or interfere with the study.
结局指标
主要结局
Progression-free Survival
时间窗: 2 years
Progression-free survival means the duration from enrollment to disease progression or death.
次要结局
- Overall survival(2 years)
研究者
Dongling Zou
Director of Gynecologic Oncology Department
Chongqing University Cancer Hospital