Using stem cells to support chemotherapy for ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of autologous hematopoietic stem cell transfusion in supporting the recovery of bone marrow function after chemotherapy in patients with ovarian cancer. Participants are divided into two groups: one receiving conventional chemotherapy alone and the other receiving chemotherapy followed by stem cell transfusion. The primary endpoints include the incidence and duration of severe neutropenia and the time taken for hematopoietic recovery. Secondary endpoints assess chemotherapy dose adjustments, incidence of febrile neutropenia, and the safety of the stem cell reinfusion therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou, M.D.
• Email: cqzl_zdl@163.com
• Phone: 13657690699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.