Actively Recruiting
Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer
Led by Anhui Provincial Cancer Hospital · Updated on 2024-05-02
28
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
A
Anhui Provincial Cancer Hospital
Lead Sponsor
A
Anhui Kecheng intelligent health technology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Confirmed advanced (FIGO IIIC/IV) high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma by surgery or biopsy
- ECOG performance status score of 0 or 1
- Ability and agreement to provide blood and tissue samples before, during, and after treatment for research
- At least one measurable tumor lesion by CT or MRI scans according to RECIST 1.1 criteria
- Expected survival of at least 3 months
- Judged unable to achieve complete tumor removal (R0 resection) or intolerant to surgery by a gynecologic oncologist
- Meet specific health criteria for blood counts, kidney, liver, lung, and heart function within 7 days before treatment
- No history of intestinal obstruction within the past 2 months
- Use effective contraception if of reproductive age
- Provide voluntary informed consent
- Willing and able to comply with study follow-up and procedures
You will not qualify if you...
- Received drugs or other cell immunotherapy in other clinical trials within 28 days before screening
- History of other cancers in the past 5 years
- Ongoing acute illness or severe illnesses in past 2 years such as active infections, fever, or severe heart failure
- History of immunodeficiency diseases including HIV
- History of organ transplant or organ failure, or on long-term immunosuppressive therapy
- Thromboembolic events like stroke or deep vein thrombosis within 6 months
- Allergy to any components of the METR-NK cell product
- Breastfeeding or positive pregnancy test during screening
- Mental illnesses including epilepsy, dementia, severe depression, or bipolar disorder
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Cancer Hospital
Hefei, Anhui, China
Actively Recruiting
Research Team
B
Bai-Rong Xia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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