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NOT YET RECRUITING
NCT07239622
PHASE2

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

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-01-01

Completion Date

2029-12-31

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

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.