Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07591831
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    Liposomal irinotecan 70 mg/m\^2 will be administered by intravenous infusion every 2 weeks.

Study Details

This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of liposomal irinotecan combined with enlonstobart in patients with platinum-resistant recurrent ovarian cancer. Eligible female participants with histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV, will receive liposomal irinotecan and enlonstobart every 2 weeks. Tumor assessment will be performed every 8 weeks. Participants may discontinue study treatment in the event of disease progression, intolerable toxicity, withdrawal of consent, or other reasons judged by the investigator.

Key Dates

Start date
May 30, 2026
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
May 30, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Liposomal Irinotecan Plus Enlonstobart
    Participants will receive liposomal irinotecan 70 mg/m\^2 by intravenous infusion every 2 weeks and enlonstobart 240 mg by intravenous infusion every 2 weeks. Each treatment cycle is 14 days. Tumor assessment will be performed every 8 weeks, or every 4 cycles. Participants with disease progression or intolerable toxicity may discontinue study treatment and receive other antitumor therapy at the investigator's discretion.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Every 8 weeks, up to 12 months ]

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