NCT07239622

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

Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

\*\*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.

Detailed description

\*\*(1)\*\* This study plans to enroll \*\*36 patients\*\* with recurrent or persistent ovarian clear cell carcinoma (OCCC). Patients who meet all inclusion criteria and do not meet any exclusion criteria will be enrolled in the study. \*\*(2) Treatment regimen: liposomal irinotecan + sintilimab + anlotinib\*\* \* \*\*Liposomal irinotecan:\*\* Initial dose 50 mg/m²; if well tolerated, increased to 70 mg/m² at the next cycle. Administered once every 3 weeks (Q3W), intravenous infusion on Day 1 of each cycle. * \*\*Sintilimab:\*\* 200 mg, intravenous infusion (30-60 minutes), Day 1 of each cycle. * \*\*Anlotinib:\*\* 8 mg orally, starting on Day 1 of each cycle, administered for 2 weeks followed by 1 week off. \*\*Administration sequence:\*\* On Day 1 of each cycle, medications are administered in sequence: patients take anlotinib capsules orally while fasting, followed by intravenous infusion of sintilimab. After an interval of at least 30 minutes, liposomal irinotecan is administered intravenously. Patients will continue treatment until disease progression, unacceptable toxicity, initiation of new anticancer therapy, withdrawal of informed consent, loss to follow-up, death, or other conditions requiring treatment discontinuation per protocol. If anlotinib must be temporarily or permanently discontinued due to intolerable toxicity during combination therapy, patients may continue sintilimab and liposomal irinotecan until disease progression, unacceptable toxicity, initiation of new therapy, withdrawal of consent, loss to follow-up, death, or termination by the investigator or sponsor. If sintilimab must be temporarily or permanently discontinued due to intolerable toxicity, patients may continue anlotinib and liposomal irinotecan under the same termination conditions. If liposomal irinotecan must be temporarily or permanently discontinued due to intolerable toxicity, patients may continue anlotinib and sintilimab under the same termination conditions. This study aims to evaluate the \*\*efficacy and safety\*\* of sintilimab combined with anlotinib and liposomal irinotecan in patients with histologically confirmed platinum-resistant recurrent or persistent OCCC. After completing all patient evaluations, a trained study coordinator will introduce the study protocol to potentially eligible participants and provide counseling. Patients who voluntarily agree to participate will be informed of all study details, after which written informed consent will be obtained. Baseline characteristics will be collected from all consented patients, who will then receive sintilimab, anlotinib, and liposomal irinotecan therapy. Subsequent treatment will follow standard clinical practice. After completion of treatment, patients will be followed every \*\*3 months during the first year\*\*, \*\*every 6 months during years 2-5\*\*, and \*\*annually thereafter\*\*. Follow-up assessments will be conducted during each scheduled visit.

Conditions

• Ovarian Cancer
• Ovarian Clear Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Treatment	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-11-20
• Last updated: 2025-11-20