NCT06884345

METR-NK Cells in Combination With Anti-angiogenic Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer

Safety and Efficacy of METR-NK Cells Combined With Solantinib Neoadjuvant Therapy in HRD+ Advanced Epithelial Ovarian Cancer: a Single-arm, Single-center, Exploratory Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 cancer by using solantinib combined with METR-NK neoadjuvant therapy

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 \> 150 drops/min, each METR - venous back to the throughput of NK cells is lower than 2 x 107 cells/kg, abdominal cavity to throughput of no less than 4 x 107 cells/kg, Three consecutive reinfusion days were taken as a course, and four consecutive reinfusion courses were given, with an interval of 14 days between each course. The position was changed every 15 min after the end of each infusion to ensure that the cells were evenly distributed to the tumor surface to achieve the therapeutic effect.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	METR-NK cells combined with Solvatinib	Sorafenib 250mg po qd, 3 weeks as a course, a total of 3 courses, the drug was stopped 3 weeks before cytoreduction of intermediate tumor. Dilute METR - 200 mL of NK cells in 37 ℃ 1500 mL of 0.9% sodium chloride physiological saline, intraperitoneal infusion, flow rate \> 150 drops/min, each METR - venous back to the throughput of NK cells is lower than 2 x 107 cells/kg, abdominal cavity to throughput of no less than 4 x 107 cells/kg, Three days of continuous infusion was taken as a course of treatment, and four courses of continuous infusion (the first course of infusion did not use METR-NK cells) were given, with an interval of 14 days for each course. The position was switched every 15 min after the completion of each infusion to ensure uniform distribution of cells to the tumor surface.

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: China