ovarian cancer
Conditions
Interventions
experimental group:AK112 combined with chemotherapy
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written informed consent form (ICF). 2. The age at enrollment should be >= 18 years old and = 3 months. 5. Epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer diagnosed by histology or cytology. 6. The subject has platinum-resistant recurrent disease. The definition of platinum resistance: Disease progression occurs within 6 months after the last platinum-based chemotherapy. 7. Having previously received 1- 2 lines of systemic chemotherapy regimens. 8. Having never received treatment with PD-1/PD-L1 immune checkpoint inhibitors before. 9. Previous treatment with anti-angiogenic drugs (including bevacizumab or small molecule TKIs) is allowed. 10. According to RECIST v1.1, there should be at least one measurable lesion. Note: Brain metastases cannot be used as target lesions; Lesions after radiotherapy cannot be used as target lesions, unless imaging proves definite progression. 11. Good organ function is determined by the following requirements: a) Hematology (without using any blood components and cell growth factor support treatment within 7 days before the start of study treatment): i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (1,500/mm3); ii. Platelet count >= 100 × 1^09/L (100,000/mm3); iii. Hemoglobin >= 90 g/L. b) Kidney: i. The calculated value of creatinine clearance rate* (CrCl) >= 50 mL/min, or serum creatinine (creatinine, Cr) = 28 g/L. d) Coagulation function: i. The international normalized ratio and activated partial thromboplastin time = 50%. 12. Female subjects with fertility must undergo urine or serum pregnancy tests within 3 days before the first administration of the drug (if the result of the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test should be conducted, and the result of the serum pregnancy test shall prevail), and the result should be negative. If a female subject with fertility has sexual intercourse with an unsterilized male partner, the subject must adopt an acceptable contraceptive method starting from the screening, and must agree to continuously use the contraceptive method within 120 days after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator. 13. Subjects are willing and able to comply with the visits, treatment regimens, laboratory tests stipulated in the schedule, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Malignant ovarian tumors from other sources (such as malignant germ cell tumors). 2. Having suffered from other malignant tumors in the past (within 3 years) or simultaneously, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.). 3. Having participated in the treatment of experimental drugs or used experimental devices within 4 weeks before the first administration of the study drug. 4. Not having undergone primary debulking surgery (PDS) or interval debulking surgery (IDS) for standard and satisfactory initial tumor cytoreduction. 5. Having received palliative local treatment for non-target lesions within 2 weeks before the first administration of the drug; having received non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks before the first administration of the drug; having received Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 1 week before the first administration of the drug. 6. Suffering from active autoimmune diseases that required systemic treatment in the past two years (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered as a kind of systemic treatment. 7. Having a history of active or previous definite inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis or chronic diarrhea). 8. Having a history of immune deficiency; being positive for HIV antibody test; currently using systemic corticosteroids or other immunosuppressants on a long-term basis. 9. Known to have active tuberculosis (TB). Subjects suspected of having active TB need to undergo clinical examinations for exclusion; known active syphilis infection. 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 11. Having a history of non-infectious pneumonia/interstitial lung disease that required systemic glucocorticoid treatment in the past or currently having non-infectious pneumonia. 12. Having suffered from severe infections within 4 weeks before the first administration of the drug, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; having active infections that received systemic anti-infective treatment within 2 weeks before the first administration of the drug (excluding antiviral treatment for hepatitis B or hepatitis C). 13. Subjects with currently active hepatitis B (HBsAg positive and HBV-DNA exceeding 2000 copies/ml or higher than the lower limit of detection, whichever is higher). Note: For subjects with hepatitis B, it is required to receive anti-hepatitis B virus treatment during the study treatment. 14. Subjects with active hepatitis C (HCV antibody positive and HCV-RNA level higher than the lower limit of detection). 15. Having undergone major surgical operations or suffered from severe trauma within 30 days before the first administration of the drug, or having a plan for major surgical operations within 30 days after the first administration of the drug (as determined by the investigator); having undergone minor local surgeries within 3 days before the first administration of the drug (excluding p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DoR;TTR;PFS;OS;The incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactDongyan Cao
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed