Intraperitoneal SK-NK cell infusion for advanced ovarian cancer with massive ascites
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 will try giving highly activated donor NK cells directly into the abdomen once weekly for four weeks to see if it helps people with advanced ovarian cancer who have large-volume malignant ascites and no standard treatment options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07435701 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm Phase I/II trial delivers allogeneic activated NK cells (SK-NK) by intraperitoneal perfusion to patients with advanced ovarian cancer and massive ascites. Phase I uses a 3+3 dose-escalation design with three dose levels (3×10^8, 6×10^8, 9×10^8 cells) to determine dose-limiting toxicities and the recommended Phase 2 dose (RP2D). Phase II expands at the RP2D to assess activity against ascites volume and tumor control. Participants receive one infusion weekly for four weeks with safety and preliminary efficacy endpoints monitored.
Who should consider this trial
Good fit: Women aged 18–75 with histologically or cytologically confirmed advanced ovarian cancer, massive malignant ascites (≥2000 mL), ECOG 0–2, adequate organ function, expected survival ≥3 months, and who have failed at least two lines of standard therapy are ideal candidates.
Not a fit: Patients with very poor organ function, active uncontrolled infections, life expectancy under three months, or those who can receive effective standard therapy are unlikely to benefit from this experimental intraperitoneal NK-cell approach.
Why it matters
Potential benefit: If successful, the therapy could reduce ascites and slow tumor growth, relieving symptoms and improving quality of life for patients who have exhausted standard options.
How similar studies have performed: Early-phase trials of adoptive NK-cell and intraperitoneal immune-cell therapies have shown acceptable safety and occasional reductions in ascites or tumor burden, but large controlled data are not yet available.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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) . Exclusion Criteria: Prior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion. Receipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion. Receipt of systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed). Major surgery within 4 weeks prior to screening or planned major surgery during the study period. History of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer). History of active or suspected autoimmune or inflammatory disease. History of organ transplantation or hematopoietic stem cell transplantation. Presence of active infection, including: Active Hepatitis B (HBsAg positive and HBV-DNA \> 1000 copies/mL) Active Hepatitis C (HCV antibody positive and HCV-RNA detected) Systemic active infection requiring antibiotic treatment Congenital or acquired immunodeficiency (e.g., HIV infection) Vaccination with live or attenuated vaccines within 4 weeks prior to intraperitoneal perfusion. Severe cardiovascular diseases, including: Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg) History of hypertensive crisis or hypertensive encephalopathy Cardiovascular accident, TIA, myocardial infarction, unstable angina, or significant vascular disease within 6 months NYHA Class ≥ II heart failure or LVEF \< 50% Severe arrhythmia uncontrolled by medication (QTc ≥ 450 ms for males, ≥ 470 ms for females), or congenital Long QT syndrome Severe respiratory disease (e.g., history of severe interstitial lung disease, severe COPD), FEV1 \< 2L, or DLCO \< 40%. History of clear neurological or psychiatric disorders, including epilepsy or dementia. Other conditions considered unsuitable for the study by the investigator (e.g., prior Grade ≥ 3 adverse events from immunotherapy).
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ning Li, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Ning Li, MD
- Email: liningnci@126.com
- Phone: 8610-87787211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.