Status:
ACTIVE_NOT_RECRUITING
METR-NK Cells in Combination With Anti-angiogenic Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer
Lead Sponsor:
Anhui Provincial Cancer Hospital
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
To further evaluate and observe the efficacy and safety of solantinib combined with METR-NK neoadjuvant therapy for advanced epithelial ovarian cancer in patients with advanced epithelial ovarian canc...
Detailed Description
Sorafenib 250mg po qd, 3 weeks as a course, a total of 3 courses. Dilute METR - 200 mL of NK cells in 37 ℃ 1500 mL of 0.9% sodium chloride physiological saline, intraperitoneal infusion, flow rate \> ...
Eligibility Criteria
Inclusion
- Age 18-70 years old (≥18, ≤70);
- Open surgery, laparoscopic surgery or coarse needle puncture biopsy and pathology confirmed late in the center of the local laboratory (FIGO IIIC/IV) high grade serous ovarian cancer, high grade endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer; Organization/blood samples confirmed HRD positive;
- ECOG score: 0-1;
- before, during, and after treatment of blood and tissue samples can get, and the participants agreed to at the center of the blood and tissue samples to laboratory for the expansion of the trial research purposes.
- At least one measurable lesions, CT/MRI according to RECIST 1.1 standard; • • Expectations alive at least 3 months;
- By professional gynecological oncologist judgment cannot achieve R0 reduced tumor or cannot tolerate surgery patients, cannot achieve the judgment standard of R0 reduced tumor including but not limited to:
- Fagotti cavity mirror scoring eight points or more; 2) when the laparoscopic evaluation methods is difficult to implement, can be used on abdominal CT score 3 points or more;
- Can't tolerate surgery judgment standard may be considered: age: the age of 70 or higher; Body mass index (BMI) : BMI 40.0 or higher; A variety of chronic diseases; Malnutrition or hypoalbuminemia; To a large number of ascites; A new diagnosis of venous thromboembolism (greater than 12 weeks of survival);
- Main organs function within 7 days before the treatment, meet the following criteria: hematologic studies: 90 g/L or higher hemoglobin, white blood cells or 3 x 109 / L, neutrophil count (ANC) absolutely acuity 1.5 x 109 / L, platelets or 90 x 109 / L; Kidney: serum creatinine \< 1.5 mg/dl, glomerular filtration rate (GFR) or greater 50 ml/min (based on the screening of Fairview Laboratories formula); Liver: AST, ALT, and alkaline phosphatase (agency 3 times normal limit, total bilirubin \< 1.5 times that of the upper limit of normal; Lung function: resting state oxygen saturation under 90% or more; Heart function: by echocardiography, MUGA or cardiac magnetic resonance imaging (MRI) of 40% or more LVEF; There was no electrocardiographic evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, or acute ischemia or active conduction system abnormalities;
- Two months without obstruction history;
- Childbearing age patients effective birth control measures should be taken;
- Subjects were willing to join in this study, and sign the informed consent (ICF);
- Expected, adherence to the good curative effect and adverse reaction will be effected according to the plan calls for follow-up.
Exclusion
- 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;
- Organ transplant or organ failure patients, patients receiving immunosuppressive therapy after organ transplantation, or patients taking immunosuppressive drugs long-term;
- Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism within 6 months;
- Known allergy to any component of the final product of METR-NK preparation, including human serum albumin;
- Breastfeeding during the screening period or female subjects with positive serum or urine pregnancy tests;
- Patients with mental illnesses, including epilepsy, dementia, severe depression, bipolar disorder, etc.;
- Other conditions deemed unsuitable for inclusion by the investigator.
Key Trial Info
Start Date :
March 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06884345
Start Date
March 13 2025
End Date
December 31 2028
Last Update
March 19 2025
Active Locations (1)
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1
Anhui Cancer Hospitail
Hefei, Anhui, China, 230001