Ovarian Cancer Recurrent
Conditions
Keywords
microtransplantation
Brief summary
In this study, we will apply micro transplantation to the field of recurrent and advanced ovarian cancer to study the efficacy and safety.
Detailed description
The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.
Interventions
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
Sponsors
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients are 18-80 years old, female，regardless of race; * Advanced / relapsed ovarian cancer confirmed by clinical or histopathological diagnosis; * More than two kinds of tumors are allowed; * Karnofsky score ≥ 60, ECoG physical status ≤ 2; * Sensitive to chemotherapy or radiotherapy; * There are measurable lesions; * There are suitable hematopoietic stem cell donors
Exclusion criteria
* have no suitable donor or donor refused * patient refused to accept donor cells
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events | 1 month | Treatment related mortality |
| time of hematopoietic recovery | 1 month | Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 1year | (markedly effective + effective) / number of patients × 100% |
Countries
China
Contacts
Primary ContactWEIPING LI
Backup ContactQIYUN Sun
Outcome results
None listed