Chemotherapy Supported by Autologous Hematopoietic Stem Cells

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.