A Single-Arm, Open-Label Phase I/II Clinical Trial of Intraperitoneal Perfusion of SK-NK Cell Injection for the Treatment of Advanced Ovarian Cancer Patients With Massive Ascites
This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites . The study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity . The study consists of two phases: Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a 3+3 design with three increasing dose levels. Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D. Participants will receive the study treatment once weekly for 4 weeks.
• Voluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up.
• Female, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons .
• Complicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.
• Expected survival time ≥ 3 months.
• Adequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as:
• Neutrophils (ANC) ≥ 1.0×10\^9/L Platelets (PLT) ≥ 80×10\^9/L Hemoglobin (Hb) ≥ 80 g/L Total Bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome or liver metastasis) ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis is present) INR ≤ 1.5×ULN and APTT ≤ 1.5×ULN (unless on anticoagulant therapy) Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula) Toxicities from prior therapies must have recovered to ≤ Grade 1 (except for alopecia and ≤ Grade 2 neurotoxicity caused by chemotherapy) .