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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

\*\*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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Treatment

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

This trial has no locations