Chemotherapy Supported by Autologous Hematopoietic Stem Cells
- Conditions
- Ovarian Cancer
- Interventions
- Other: Autologous blood transfusion with haematopoietic stem cells
- Registration Number
- NCT05401162
- Lead Sponsor
- Chongqing University Cancer Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
1）18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)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;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)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;10)bone marrow function is good,ability to perform stem cell mobilisation and collection.
- patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Autologous blood transfusion with haematopoietic stem cells transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy
- Primary Outcome Measures
Name Time Method Time to reconstruct haematopoietic function 8 months Time to reconstruct haematopoietic function
Incidence of febrile neutropenia (FN) 8 months Incidence of febrile neutropenia (FN)
Incidence of Grade 3-4 neutropenia 8 months Incidence of Grade 3-4 neutropenia
- Secondary Outcome Measures
Name Time Method the rate of postponement of the course for chemotherapy 8 months the rate of postponement of the course for chemotherapy
reduction in chemotherapy dose 6 months reduction in chemotherapy dose
Safety of hematopoietic stem cell reinfusion therapy 3 months Safety of hematopoietic stem cell reinfusion therapy(adverse events)
Trial Locations
- Locations (1)
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China