Cervical CancerNCT05401175
Hematopoietic Stem Cell-containing Autologous Blood Reinfusion for Bone Marrow Protection in Cervical Cancer Patients
A study testing Autologous blood transfusion with haematopoietic stem cells in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Autologous blood transfusion with haematopoietic stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Dongling Zou, M.D., 13657690699, cqzl_zdl@163.com
Dongling Zou, M.D.
About this study
Official title: Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy
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.
Read the detailed 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.
- Conditions
- Cervical Cancer
- Being tested
- Autologous blood transfusion with haematopoietic stem cells
- Keywords
- Cervical Cancer, concurrent chemoradiotherapy, blood stem cells, autologous blood transfusion
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood transfusion with haematopoietic stem cellsOther
Transfusion of autologous blood containing haematopoietic stem cells for haematopoietic reconstruction after chemoradiotherapy.Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during chemoradiotherapy, 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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous blood transfusion support therapy group | Experimental | 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. Receives: Other: Autologous blood transfusion with haematopoietic stem cells |
| Conventional treatment group | No intervention | Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Undergo standard radiotherapy for cervical cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3-4 neutropenia
Incidence of Grade 3-4 neutropenia
Measured: 6 months
Time to reconstruct haematopoietic function
Time to reconstruct haematopoietic function
Measured: 6 months
Secondary outcomes (4)
the rate of postponement of the course of chemoradiotherapy
the rate of postponement of the course of chemoradiotherapy
Measured: 3 months
reduction in chemotherapy dose
reduction in chemotherapy dose
Measured: 3 months
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN)
Measured: 3 months
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start13 Apr 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongling Zou, M.D., Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401175
- Sponsor's protocol ID
- CQGOG0107
- Status last verified
- Jun 2026
- First submitted
- 29 May 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhargava A, Mishra DK, Jain SK, Srivastava RK, Lohiya NK, Mishra PK. Comparative assessment of lipid based nano-carrier systems for dendritic cell based targeting of tumor re-initiating cells in gynecological cancers. Mol Immunol. 2016 Nov;79:98-112. doi: 10.1016/j.molimm.2016.10.003. Epub 2016 Oct 17.
PubMed 27764711Huang BH, Li J, Zou WY, Liu JR, Gu JL, Li XZ, Chen ML, Kuang LF. [Efficacy and safety of autologous hematopoietic stem cell transplantation in elderly multiple myeloma patients: a single center retrospective study]. Zhonghua Xue Ye Xue Za Zhi. 2022 Feb 14;43(2):141-145. doi: 10.3760/cma.j.issn.0253-2727.2022.02.009. Chinese.
PubMed 35381675Fares S, Hadri H, Rachid M, Moutiqui T, Oukkache B, Quessar A. [Multiple myeloma and autologous haematopoietic stem-cell transplantation without cryopreservation: experiences of the Clinical Hematology Department of Casablanca, Morocco]. Pan Afr Med J. 2021 Jun 4;39:105. doi: 10.11604/pamj.2021.39.105.18994. eCollection 2021. French.
PubMed 34512841Corbeau A, Kuipers SC, de Boer SM, Horeweg N, Hoogeman MS, Godart J, Nout RA. Correlations between bone marrow radiation dose and hematologic toxicity in locally advanced cervical cancer patients receiving chemoradiation with cisplatin: a systematic review. Radiother Oncol. 2021 Nov;164:128-137. doi: 10.1016/j.radonc.2021.09.009. Epub 2021 Sep 21.
PubMed 34560187
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05401175
- Acronym / sponsor ID
- CQGOG0107
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, concurrent chemoradiotherapy, blood stem cells, autologous blood transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous blood transfusion support therapy group | Experimental | Other: Autologous blood transfusion with haematopoietic stem cellsBone 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. |
| Conventional treatment group | No intervention | –Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Undergo standard radiotherapy for cervical cancer. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous blood transfusion with haematopoietic stem cellsTransfusion of autologous blood containing haematopoietic stem cells for haematopoietic reconstruction after chemoradiotherapy.Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during chemoradiotherapy, 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. | Other | Autologous blood transfusion support therapy group |
Primary outcome
Incidence of Grade 3-4 neutropenia
Time frame: 6 months
Incidence of Grade 3-4 neutropenia
Time to reconstruct haematopoietic function
Time frame: 6 months
Time to reconstruct haematopoietic function
4 secondary outcomes
the rate of postponement of the course of chemoradiotherapy
Time frame: 3 months
reduction in chemotherapy dose
Time frame: 3 months
Incidence of febrile neutropenia (FN)
Time frame: 3 months
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])
Time frame: 1 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 27764711Bhargava A, Mishra DK, Jain SK, Srivastava RK, Lohiya NK, Mishra PK. Comparative assessment of lipid based nano-carrier systems for dendritic cell based targeting of tumor re-initiating cells in gynecological cancers. Mol Immunol. 2016 Nov;79:98-112. doi: 10.1016/j.molimm.2016.10.003. Epub 2016 Oct 17.
- Background: PubMed 35381675Huang BH, Li J, Zou WY, Liu JR, Gu JL, Li XZ, Chen ML, Kuang LF. [Efficacy and safety of autologous hematopoietic stem cell transplantation in elderly multiple myeloma patients: a single center retrospective study]. Zhonghua Xue Ye Xue Za Zhi. 2022 Feb 14;43(2):141-145. doi: 10.3760/cma.j.issn.0253-2727.2022.02.009. Chinese.
- Background: PubMed 34512841Fares S, Hadri H, Rachid M, Moutiqui T, Oukkache B, Quessar A. [Multiple myeloma and autologous haematopoietic stem-cell transplantation without cryopreservation: experiences of the Clinical Hematology Department of Casablanca, Morocco]. Pan Afr Med J. 2021 Jun 4;39:105. doi: 10.11604/pamj.2021.39.105.18994. eCollection 2021. French.
- Background: PubMed 34560187Corbeau A, Kuipers SC, de Boer SM, Horeweg N, Hoogeman MS, Godart J, Nout RA. Correlations between bone marrow radiation dose and hematologic toxicity in locally advanced cervical cancer patients receiving chemoradiation with cisplatin: a systematic review. Radiother Oncol. 2021 Nov;164:128-137. doi: 10.1016/j.radonc.2021.09.009. Epub 2021 Sep 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dongling Zou, M.D. principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous blood transfusion with haematopoietic stem cells in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongling Zou, M.D. (13657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3-4 neutropenia (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401175, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.