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

NCT07239622 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Huaiwu Lu · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239622 on ClinicalTrials.gov