Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to reconstruct haematopoietic function
研究概览
简要总结
The aim of this project is to use autologous haematopoietic stem cell transfusion support to promote the reconstruction of haematopoietic function after chemotherapy for ovarian cancer. To explore the impact of stored haematopoietic stem cell support therapy on bone marrow protection after conventional chemotherapy for ovarian cancer in order to facilitate its clinical application.
详细描述
Study design:In this prospective, single-center,non-randomised controlled study, patients with ovarian cancer were divided into two groups. The patients in the experimental group received autologous blood transfusion containing hematopoietic stem cells 1 day after conventional chemotherapy, while the control group only received conventional chemotherapy.
Case selection: Patients with primary ovarian cancer,ovarian cancer confirmed by histopathology, and three weeks of platinum-containing regimen chemotherapy.
Primary end point: 1)incidence and duration of grade 3/4 neutropenia in patients;2)hematopoietic reconstitution time in patients. Secondary endpoints: 1)the rate of reduction in chemotherapy dose and postponement of the course for chemotherapy;2) Incidence of febrile neutropenia (FN);3)Safety of hematopoietic stem cell reinfusion therapy (adverse events).
Safety assessment: laboratory safety testing, including platelet count,white blood cell and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, hypocalcemia,anemia and thrombocytopenia,bone pain, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-60 years old;
- •there are chemotherapy indicators for ovarian cancer;
- •ovarian cancer diagnosed by histopathology;
- •recurrent and metastatic ovarian cancer;
- •the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;
- •the expected survival time was more than 3 months;
- •pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;
- •all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;
- •the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;
- •bone marrow function is good,ability to perform stem cell mobilisation and collection.
排除标准
- •patients with bone marrow disease;
- •central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;
- •patient has severe cardiac insufficiency;
- •previous history of allogeneic stem cell transplantation or organ transplantation;
- •patients with active bleeding and autoimmune thrombocytopenic purpura;
- •patients with chemotherapy contraindications;
- •positive for human immunodeficiency virus (HIV);
- •acute or chronic active hepatitis B or hepatitis C infection.
研究组 & 干预措施
Experimental group
transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy
干预措施: Autologous blood transfusion with haematopoietic stem cells (Other)
Control group
enrolled ovarian cancer patients receive conventional chemotherapy
结局指标
主要结局
Time to reconstruct haematopoietic function
时间窗: 8 months
Time to reconstruct haematopoietic function
Incidence of febrile neutropenia (FN)
时间窗: 8 months
Incidence of febrile neutropenia (FN)
Incidence of Grade 3-4 neutropenia
时间窗: 8 months
Incidence of Grade 3-4 neutropenia
Time to reconstruct haematopoietic function
时间窗: 6 months
Time to reconstruct haematopoietic function
次要结局
- the rate of postponement of the course for chemotherapy(8 months)
- reduction in chemotherapy dose(6 months)
- Safety of hematopoietic stem cell reinfusion therapy(3 months)
- Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability](3 months)