Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma

Prior treatment

• Prior treatment with immune checkpoint inhibitors, including PD-1, PD-L1, or CTLA-4 inhibitors.
• Contraindications to anlotinib, including but not limited to: history of gastrointestinal perforation; surgery within 28 days before combination therapy or unhealed wounds; severe bleeding or recent hemoptysis; or any other condition deemed unsuitable for anlotinib use by the investigator.
• Brain metastases requiring surgical intervention.
• Vaccination within 1 month prior to study enrollment.
• Systemic corticosteroid therapy (excluding topical, inhaled, or intranasal corticosteroids) or any other form of immunosuppressive therapy (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF agents) within 7 days prior to first dosing.
• Use of systemic antitumor traditional Chinese medicine or immunomodulatory agents (e.g., thymosin, interferon, interleukin) within 2 weeks before first dosing, except for local use to control pleural effusion.
• Continuous full-dose oral or parenteral anticoagulant or thrombolytic therapy for 10 consecutive days within 10 days before first dosing.
• Unresolved toxicities from prior therapy (≥Grade 2), except for alopecia, neuropathy, lymphopenia, or skin depigmentation.

Other illness

• Known allergy to irinotecan, anlotinib, or sintilimab.
• History of other malignancies within the past 5 years.
• Active autoimmune disease within the past 2 years.
• Hereditary bleeding tendency or coagulation disorder; history of hypertension with thrombosis; tumor invasion of major vessels, or radiologic evidence suggesting risk of bleeding, as determined by the investigator or radiologist.
• History of allogeneic organ transplantation (except corneal transplant) or allogeneic hematopoietic stem cell transplantation.
• Known history of human immunodeficiency virus (HIV) infection (positive HIV-1/2 antibodies).
• Untreated active hepatitis B infection (defined as HBsAg positive with detectable HBV-DNA copies).
• Presence of severe or uncontrolled systemic diseases

Lab values

• Blood transfusion or platelet transfusion within 4 weeks before first dosing.
• Continuous use of aspirin (\>325 mg/day) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days within 10 days before first dosing.

Other

• Non-clear cell histologic subtype of ovarian carcinoma.
• Presence of serious unhealed wounds, ulcers, or fractures.

• Voluntarily agrees to participate in the clinical study and signs a written informed consent form.
• Age between 18 and 75 years, with histologically confirmed recurrent or persistent ovarian clear cell carcinoma.
• Has received at least one prior line of platinum-based chemotherapy.
• ECOG performance status of 0-2.
• Expected survival greater than 12 weeks.
• Has measurable disease as defined by RECIST version 1.1:
• Each lesion must measure ≥10 mm in its longest diameter by CT, MRI, or clinical examination;
• Lesions measured by chest X-ray must be ≥20 mm;
• Lymph nodes must have a short axis ≥15 mm when measured by CT or MRI.
• At least 4 weeks have elapsed since the last systemic anticancer therapy.
• Hematologic, hepatic, renal, thyroid, and cardiac enzyme tests are within normal limits.