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.
Female participants aged 18 to 75 years, inclusive, at the time of signing informed consent.
Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV.
Platinum-resistant recurrent disease, defined as disease progression within 6 months after the last platinum-containing chemotherapy, and not platinum-refractory disease, defined as disease progression within 4 weeks after initial platinum-containing chemotherapy. Participants may have received up to two prior lines of non-platinum systemic therapy. Treatment with a PARP inhibitor or anti-angiogenic therapy after platinum-resistant recurrence will be counted as one line of therapy; maintenance treatment with a PARP inhibitor or anti-angiogenic therapy will not be counted as a treatment line.
Ability to provide sufficient qualified formalin-fixed paraffin-embedded tumor tissue samples or slides for PD-L1 testing. Participants who are unable to provide tumor tissue slides for certain reasons may be enrolled at the investigator's discretion.
History of severe hypersensitivity reaction to monoclonal antibody preparations or uncontrolled allergic asthma.
Known untreated central nervous system metastases, or treated but still symptomatic central nervous system metastases. Participants with residual signs or symptoms related to central nervous system treatment may be eligible if neurological symptoms have been stable or improved for at least 2 weeks before screening.
History of primary immunodeficiency.
Active autoimmune disease or history of autoimmune disease. Participants with well-controlled type 1 diabetes mellitus, well-controlled hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment such as vitiligo, psoriasis, or alopecia, or conditions not expected to recur without external triggers may be eligible for further screening.
Single group
Liposomal Irinotecan
DrugLiposomal irinotecan 70 mg/m\^2 will be administered by intravenous infusion every 2 weeks.
Objective Response Rate
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST version 1.1.
Progression-Free Survival
Progression-free survival is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Overall Survival
Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the end of the study will be censored at the date they were last known to be alive.
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events, including overall adverse events, adverse events by grade, Grade 3 or higher adverse events, and serious adverse events. Adverse events will be graded according to NCI CTCAE version 5.0.
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