\*\*Primary Objective:\*\* The primary objective of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with sintilimab and anlotinib in patients with recurrent or persistent ovarian clear cell carcinoma (OCCC).
\*\*Treatment Regimen:\*\*
Participants will receive the following treatment:
* \*\*Liposomal irinotecan:\*\* Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle. * \*\*Sintilimab:\*\* 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle. * \*\*Anlotinib:\*\* 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period.
\*\*Follow-up Schedule:\*\* Patients will be followed every 3 months during treatment and within the first year after completion of therapy, every 6 months from Year 2 to Year 5, and annually thereafter. Follow-up assessments will include physical examination, laboratory testing, and imaging studies.
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.
Non-clear cell histologic subtype of ovarian carcinoma.
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.
Known allergy to irinotecan, anlotinib, or sintilimab.
Single group
Treatment
DrugParticipants will receive the following treatment: Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle. Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle. Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients whose tumors have shrunk to a predefined extent, including cases achieving complete response (CR) or partial response (PR). Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Measurable lesions will be documented before treatment initiation, and tumor assessments will be performed every two treatment cycles to evaluate changes until disease progression or treatment discontinuation. According to RECIST v1.1, treatment response will be categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions or the appearance of new lesions.
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