Hematopoietic Stem Cell-containing Autologous Blood Transfusion for Bone Marrow Protection in Patients With Cervical Cancer

Chongqing University Cancer Hospital

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Other: Autologous blood transfusion with haematopoietic stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05401175

CQGOG0107

Details and patient eligibility

About

The aim of this project is to promote the reconstruction of haematopoietic function after chemoradiotherapy for cervical cancer with the innovative use of autologous haematopoietic containing stem cell blood transfusion support.To explore the effect of stored hemopoietic stem cell support therapy on bone marrow protection after concurrent chemoradiotherapy, in order to promote its clinical application.

Full description

Study design:In this prospective, single-center,non-randomised controlled study, patients with cervical cancer are divided into two groups. Patients in the autologous blood transfusion support therapy group will receive autologous blood transfusion containing haematopoietic stem cells after completion of concurrent chemoradiotherapy, whereas the conventional treatment group receive concurrent chemoradiotherapy only. Frozen stored autologous peripheral blood transfusion 1 day after completion of chemoradiotherapy.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.

Case selection: Patients with primary cervical cancer,squamous, adenocarcinoma or adenosquamous carcinoma cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and platinum chemotherapy with concurrent radiotherapy.

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 postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1）18-60 years old; 2)there are radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)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;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)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.

Exclusion criteria

1. clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;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 radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and/or fistula, clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Autologous blood transfusion support therapy group

Experimental group

Description:

Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Peripheral blood stem cells were mobilized, frozen and stored before treatment. Resuscitate and reinfusion autologous peripheral blood 24 hours after completion of concurrent chemoradiotherapy.

Treatment:

Other: Autologous blood transfusion with haematopoietic stem cells

Conventional treatment group

No Intervention group

Description:

Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Undergo standard radiotherapy for cervical cancer.