The goal of this type of clinical trial study is to evaluate the safety and efficacy of metabolic remodeling nature killer cells as neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer
Age: 18-70 years old (≥18, ≤70);
Open surgery, laparoscopic surgery, or coarse needle biopsy for histopathological confirmation of advanced (FIGO IIIC/IV stage) high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal carcinoma, and/or fallopian tube carcinoma, etc.;
ECOG score: 0-1;
Blood and tissue specimens before, during, and after treatment can be obtained, and subjects agree to submit blood and tissue specimens to the central laboratory for the purpose of expanding research in this trial;
Patients who have received drugs or other cell immunotherapy in other clinical trials within 28 days before the screening period;
Patients who have had other malignant tumors in the past 5 years;
Acute illnesses are ongoing, or severe illnesses have occurred in the past 2 years, such as patients with active infections or fever, cardiovascular diseases (Grade III or IV heart failure), mental health issues (such as alcoholism, drug abuse);
History of immunodeficiency, including HIV-positive status or other acquired, congenital immunodeficiency diseases;
Single group
METR-NK cell(Metabolic Remodeling Nature Killer Cells)
DrugThe minimum amount of METR-NK cells infused each time should be no less than 7.5×10\^7 cells, Continuous infusion for 2 days constitutes one course, with 4 courses. The infusion is given every 2 weeks.
R0 resection rate
the percentage of patients received R0 resection after METR-NK cells as neoadjuvant therapy for advanced epithelial ovarian cancer
Overall Response Rate (ORR) After Neoadjuvant treatment
Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Pathological complete remission rate
No residual invasive carcinoma was found under the microscope, but ductal carcinoma in situ could be found; In addition, compare the amount of cancer cells in the specimen before and after the new adjuvant therapy, and use of the Miller Payne grading system to evaluate the effect of the new adjuvant therapy
Disease control rate
the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated
Progression free survival
the date of enrollment to the date of the first onset of disease progression or death from any cause, whichever comes first
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Anhui Provincial Cancer Hospital
Lead sponsor
Anhui Kecheng intelligent health technology Co., LTD
Collaborator
