ovarian cancer
Conditions
Interventions
Intervention group:AK104+chemotherapy+bevacizumab (chemotherapy = 6 cycles), followed by maintenance with AK104 ± bevacizumab
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary agreement to provide written informed consent. 2. Female, Age 18 -75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Predicted survival = 3 month. 5.Confirmed by histology or cytology as epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 6.Previously received either first or second line systemic treatment, including at least one platinum based drug (subjects must receive at least four cycles of platinum based drug in first-line treatment, and if platinum based drug in first-line is terminated due to toxic reactions, they are allowed to participate in this study after consultation with PI); Adjuvant therapy ± neoadjuvant therapy is considered as first-line treatment; Disease progression within 6 months (180 days) after the last dose of platinum based chemotherapy by imaging (i.e. platinum resistant disease) . 7. Have at least one evaluable lesion (RECIST 1.1 criteria),according to RECIST v1.1, this lesion is suitable for repeated and accurate measurements. Lesions that have undergone radiotherapy and have clearly progressed, that can be measured based on imaging can be considered as target lesions. 8. Good organ function through the following requirements: a) Hematology (did not use any blood components or cell growth factor support therapy within 7 days before starting the study ): i. The absolute value of neutrophil ANC is = 1.5 × 10^9/L (1500/mm3). Ii. Platelet count = 100 × 10^9/L (100000/mm3). Iii. Hemoglobin = 90 g/L. b) Kidney: i. The calculated value of creatinine clearance rate * (CrCl) is = 50 mL/min. *The Cockcroft Gault formula will be used to calculate CrCl (Cockcroft Gault formula) CrCL (mL/min)=[(140- age) x body weight (kg) x F]/(SCr (mg/dL) x 72) Among them, F=1 for males and F=0.85 for females; SCr=serum creatinine. Ii. Urinary protein<2+or 24-hour (h) urinary protein quantification<1.0 g. c) Liver: i. Serum total bilirubin (TBil) = 1.5 × ULN. Ii. AST and ALT = 2.5 × ULN. d) Coagulation function: i. The international normalized ratio (INR) and activated partial thromboplastin time (APTT) are = 1.5 × ULN. 9. Female with fertility must undergo a urine or serum pregnancy test within 3 days before the first use of medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, based on the serum pregnancy result), and the result must be negative. If a female with fertility has sexual intercourse with an unsterilized male , the subject must adopt an acceptable contraceptive method, and must agree to continue using the contraceptive method for 120 days after the last administration of drug; Whether or not to stop contraception after this point should be discussed with the researchers. 10. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Non-epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (such as germ cell tumors),low malignant ovarian tumors (such as borderline tumors) 2.Primary platinum refractory disease, defined as disease progression during first-line platinum chemotherapy treatment according to RECIST v1.1. Note: Subjects with secondary platinum refractory disease (defined as a disease progression during second-line platinum based drug as assessed by RECIST 1.1) are eligible to participate in the study, as long as there is imaging evidence of disease progression within 6 months after completing first-line platinum based drug treatment for ovarian cancer. 3.History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above, and breast cancer with no recurrence>3 years after the completion of radical surgery . 4.Local recurrence was suitable for surgery. 5.Participated in the trial of experimental drugs or instruments within 4 weeks prior to the first administration. 6.Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumor immune mechanisms treatment . 7.Received the last systemic anti-tumor treatment, including chemotherapy, within 3 weeks prior to the first administration; Received anti-tumor hormone therapy within 2 weeks before the first administration; Received palliative local treatment on non-target lesions within 2 weeks prior to first administration; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before first administration; Received Chinese herbal medicine with anti-tumor indications within 1 week before first administration. 8.Active autoimmune diseases that require systematic treatment within two years prior to the start of treatment, or autoimmune diseases may relapse during the study period. Excluding skin diseases that do not require systematic treatment (such as vitiligo, hair loss, psoriasis, or eczema); Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Well controlled type I diabetes; completely relieved childhood asthma and do not require any intervention in adulthood; investigator determine no disease recurrence without external triggering factors. 9.Inflammatory bowel diseases with activity or requiring clinical treatment, such as Crohn's disease, ulcerative colitis, or chronic diarrhea. 10.Required systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to enter the trial.In the absence of active autoimmune diseases, inhaled or external steroids and adrenal replacement doses >10mg daily prednisone equivalent are allowed. Subjects are allowed to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (with minimal systemic absorption). The physiological alternative dose of systemic corticosteroids is allowed, even if it is >10 milligrams per day of prednisone equivalent. Allow short-term use of corticosteroids for prevention (such as contrast agent allergies) or treatment of non autoimm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Progression free survival, PFS;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactYang Hongying
Yunnan Cancer Hospital
Outcome results
None listed