Overview
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.
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.
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
1) 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.