Platinum-Resistant Recurrent Ovarian Cancer
Conditions
Interventions
Experimental group:Irinotecan liposome (II): 60 mg/m2, D1, intravenous infusion, Q3W
Adebrelimab: 20 mg/kg, D1, intravenous infusion, Q3W
Sponsors
Renji Hospital Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form and voluntarily participate in this study; 2. Female participants aged >=18 years and 3 months; 5. Histologically or cytologically confirmed ovarian cancer; 6. Platinum-resistant recurrent disease, defined as disease progression within 6 months of last platinum-based chemotherapy; 7. At least one measurable lesion according to RECIST 1.1 criteria; 8. Normal major organ function: a) Hematology: Neutrophils >= 1.5 × 10^9/L, Hemoglobin >= 9 g/dL, Platelets >= 100 × 10^9/L. b) Hepatic function: Bilirubin = 3 g/dL; c) Renal function: Serum creatinine =60 mL/min d) Coagulation function: International Normalized Ratio (INR) <= 1.5×ULN; Activated partial thromboplastin time (APTT) <= 1.5×ULN 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to study drug administration, must not be breastfeeding, and must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms with an annual failure rate <1%) during the trial and for 6 months after the last dose. Whether to discontinue contraception after this period should be discussed with the investigator. 10. Subjects must demonstrate good compliance and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) identified by CT or MRI evaluation during screening; 2. Known allergy to any component of the study drugs; 3. Participation in treatment with investigational drugs or use of investigational devices within 4 weeks prior to the first study dose; 4. Prior treatment with PD-1/PD-L1 immune checkpoint inhibitors; 5. History of malignancy other than ovarian cancer within 5 years prior to enrollment, except for malignancies with negligible risk of metastasis or death [e.g., expected 5-year overall survival > 90%] and those expected to be cured after treatment, such as appropriately treated cervical carcinoma in situ, basal or squamous cell skin carcinoma, and ductal carcinoma in situ treated with curative surgery; 6. History of or current use of any of the following treatments: a) Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (dose > 10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration; Inhaled or topical steroids and corticosteroid replacement therapy at a dose > 10 mg/day prednisone or equivalent are permitted in the absence of active autoimmune disease; b) Received a live attenuated vaccine within 4 weeks prior to the first dose of study drug; c) Undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of study drug; 7. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Individuals with psoriasis or childhood asthma/allergies that have achieved complete remission without requiring any intervention in adulthood may be considered for inclusion; however, patients requiring medical intervention with bronchodilators are excluded; 8. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation; 9. Uncontrolled cardiac clinical symptoms or disease, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias uncontrolled despite clinical intervention or with poor control after intervention; 10. Severe infection (CTCAE >= Grade 2) within 4 weeks prior to first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, or infection-related complications; exclusion if baseline chest imaging indicates active pulmonary inflammation, or if symptoms/signs of infection or need for oral/IV antibiotics exist within 14 days prior to first study drug administration (excluding prophylactic antibiotic use); 11. Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation > Grade 2; diarrhea > Grade 1); 12. Active pulmonary tuberculosis infection identified by medical history or CT scan, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment; 13. Active hepatitis B (HBV DNA >= 200 IU/mL or 1000 copies/mL or >= upper limit of normal) or hepatitis C (HCV antibody positive with HCV RNA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-month objective response rate; | — |
Countries
China
Contacts
Public ContactWen Di/Weihua Lou
Renji Hospital Shanghai Jiao Tong University School of Medicine
Outcome results
None listed