Endometrial cancer
Conditions
Sponsors
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subject is able to understand and voluntarily join this study, and the informed consent form must be signed before performing the specified study procedures required by the study, with good compliance. (2) Age = 18 years on the day of signing the informed consent, female. (3) Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. (4) Expected survival of more than 3 months. (5) Histologically or cytologically confirmed endometrial cancer. a) The pathological type is endometrioid carcinoma; b) any anti-tumor therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy) other than surgery and chemotherapy; c) FIGO 2009 is staged in stages III.A-IV.A. (6) At least one measurable lesion according to RECIST v1.1 criteria. (7) All subjects must be willing to provide tumor tissue samples prior to randomization. (8) The results of laboratory tests during the screening period indicate that the subject has good organ function: a) Hematology (no use of any blood components and cell growth factor supportive therapy is allowed within 2 weeks prior to randomization): absolute neutrophil ANC = 1.5 ×109/L; Platelet count =100×109/L; Hemoglobin = 9.0 g/dL. b) Renal: creatinine =1.5× ULN or creatinine clearance* (CrCl) calculated value = 50 mL/min; * CrCl was calculated using the Cockcroft-Gault formula, CrCl (mL/min) = [(140-age) × body weight (kg) × 0.85]/[serum creatinine (mg/dL) × 72); c) Liver: serum total bilirubin (TBil) = 1.5 × ULN; Subjects with evidence confirmed/suspected of Gilbert's disease, TBil = 3× ULN; AST and ALT = 2.5× ULN; d) Coagulation function: International normalized ratio (INR) = 1.5 × ULN and activated partial thromboplastin time (APTT) = 1.5 × ULN (if the subject is receiving anticoagulant therapy, the subject must be on a stable dose of anticoagulant and the coagulation parameters (PT/INR and APTT) are within the expected range of treatment with anticoagulants at screening).
Exclusion criteria
Exclusion criteria: (1) There is evidence of distant metastasis. (2) Other active malignancies within 2 years prior to randomization. (3) Presence of clinically significant bilateral hydronephrosis, which cannot be relieved by nephrostomy or ureteral stenting as judged by the investigator. (4) Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) or immune costimulatory factors (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) that targets tumor immunity. (5) Subjects requiring systemic treatment with glucocorticoids (> 10 mg/day prednisone or equivalent dose of glucocorticoids) or other immunosuppressive drugs within 2 weeks prior to randomization. (6) Received drugs with immunomodulating effects (such as thymic peptide, interferon, interleukin-2) within 2 weeks before randomization. (7) Presence of active infections requiring systemic therapy (including active tuberculosis, active treponemal infection, and fungal infections requiring systemic therapy). (8) Severe infection within 4 weeks prior to randomization. (9) Use of live vaccine within 4 weeks prior to randomization. (10) Have an active or potentially recurrent autoimmune disease; Exceptions are made for: vitiligo, alopecia, psoriasis, or eczema that does not require systemic treatment; Hypothyroidism due to autoimmune thyroiditis requiring only stable doses of hormone replacement therapy; Type I diabetes requiring only stable doses of insulin replacement therapy. (11) Any of the following cardiovascular and cerebrovascular diseases: a) hypertension (defined as systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg) that cannot be controlled by adequate antihypertensive medication, or a history of hypertensive crisis, hypertensive encephalopathy; b) Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep vein thrombosis, and any arterial thromboembolic events within 6 months prior to randomization; c) New York Heart Association (NYHA) cardiac function class = class II heart failure; d) the presence of severe cardiac arrhythmias requiring long-term pharmacological intervention; Enrollment of asymptomatic patients with atrial fibrillation with stable ventricular rate is allowed; e) Cerebrovascular events (CVA) within 6 months prior to randomization; f) left ventricular ejection fraction (LVEF) 1000 IU/mL, and subjects with active viral hepatitis C. (14) Have active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), active diverticulitis. (15) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. (16) Known history of interstitial lung disease or non-infectious pneumonitis. (17) History of known severe hypersensitivity reactions to other monoclonal antibodies. (18) Known to have any contraindication to cadonilimab. (19) Any condition that, in the opinion of the investigator, may cause the risk of receiving the study drug, or will interfere with the evaluation of the study drug or the safety of the subject or the interpretation of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety;Health-related quality of life; | — |
Countries
China
Contacts
Public ContactLin Xiaodan
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Outcome results
None listed