Chemotherapy Supported by Autologous Hematopoietic Stem Cells
ConditionOvarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorChongqing University Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-60 years old;
there are chemotherapy indicators for ovarian cancer;
ovarian cancer diagnosed by histopathology;
recurrent and metastatic ovarian cancer;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous blood transfusion with haematopoietic stem cells
Other interventionTransfusion of autologous blood containing haematopoietic stem cells for haematopoietic reconstruction after chemotherapy.Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during chemotherapy, G-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.Monitor peripheral blood after transfusion. If peripheral blood leukocyte count does not reach 1.0 x 109/L, administer G-CSF 150 μg subcutaneously daily until peripheral blood leukocyte count reaches 1.0 x 109/L.Patients were tested monthly for peripheral blood cells for 6 months after the end of treatment.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Grade 3-4 neutropenia
Incidence of Grade 3-4 neutropenia
Time frame
8 months2
Time to reconstruct haematopoietic function
Time to reconstruct haematopoietic function
Time frame
6 months3
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN)
Time frame
8 monthsSecondary outcomes
1
the rate of postponement of the course for chemotherapy
the rate of postponement of the course for chemotherapy
Time frame
8 months2
reduction in chemotherapy dose
reduction in chemotherapy dose
Time frame
6 months3
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability]
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events \[Safety and Tolerability\]
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov