Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer 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 t

Trial Details

NCT ID
NCT07435701
Phase
PHASE1 / PHASE2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • SK-NK Cell Injection
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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 mus…
  • Complicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.
  • Expected survival time ≥ 3 months.

For full eligibility, visit ClinicalTrials.gov.

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