Recurrent or oligometastatic endometrial cancer with complete response (CR) or partial response (PR) after surgery or chemoradiotherapy (CRT)
Conditions
Interventions
Experimental group:Immunotherapy(Ipardfhlimab and Tuvonralimab )
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before enrollment; 2. Age 18-75 years; 3. Histologically confirmed diagnosis of locally recurrent or oligometastatic endometrial cancer; 4. There are =3 months; 9. The functional level of vital organs within 3 days prior to the first dose must meet the following requirements (supportive therapy such as any blood components and cell growth factors is not allowed within 14 days prior to the first dose) a) Absolute neutrophil count>=1.5×10^9/L; b) Platelet >=100×10^9/L; c) Hemoglobin >=90 g/L; d) serum albumin>=30 g/L; e) AST and ALT 1.5×ULN, the creatinine clearance (CLcr) calculated using the Cockcroft-Gault equation >=50 mL/min; h) Cardiac left ventricular ejection fraction (LVEF) >50%; 10. Subject agrees to use effective contraceptive measures for contraception from the time of signing the informed consent form until 180 days after the last dose. Females of childbearing potential cannot be pregnant or breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Prior immunotherapy, such as immune checkpoint inhibitors; 2. Subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or who have had complete remission of asthma in childhood and do not need any intervention after adulthood may be included; Asthma in participants requiring medical intervention with bronchodilators could not be included); 3. Subject is using immunosuppressants, or systemic, or absorbable topical hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other efficacy hormones) and is still continuing to use it within 2 weeks prior to enrollment; 4. Known prior occurrence of Grade 3 or Grade 4 immune-related adverse events related to anti-tumor immunotherapy; 5. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or above heart failure; (2) unstable angina; (3) Myocardial infarction within half a year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc>450ms (male); QTc>470ms (female); 6. Abnormal coagulation function (INR>1.5 or PT>16s), bleeding tendency or is receiving thrombolytic or anticoagulant therapy; 7. Subjects who have received prior radiotherapy, chemotherapy, hormonal therapy, surgery, or molecularly targeted therapy, after the completion of treatment (last dose), less than 4 weeks before the study dose (or 5 drug half-lives, whichever is longer); Patients with adverse events (other than alopecia) from prior therapy who did not recover to 38.5 degrees during the screening period and before the first dose; 12. Patients with previous and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.; 13. Subject has congenital or acquired immunodeficiency (e.g., HIV-infected), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; Hepatitis C reference: HCV viral titer or RNA test value above the upper limit of normal value); 14. Patients who have used other drugs, clinical trial investigational drugs or similar treatment drugs within 4 weeks before the first dose, have undergone radiotherapy or other topical therapy within 2 weeks before the first treatment, and have not recovered from the adverse reactions of radiotherapy or other topical treatments; 15. Subject has other malignant tumors in the past or at the same time; 16. Subjects may receive other systemic anti-tumor therapy during the study; 17. Live vaccine received less than 4 weeks prior to study administration or possibly during the study period; 18. In the judgment of the investigator, the subject has other factors that may lead to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Safety;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactHao Yu
Cancer Hospital Affiliated to Shandong First Medical University
Outcome results
None listed