Endometrial Cancer
Conditions
Interventions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent; 2. Female aged 18 to 70 years; 3. Histologically confirmed diagnosis of endometrial cancer; 4. Patients must have received >=1 systemic treatment before or after completion; 5. At least one measurable lesion according to RECIST1.1 on CT; 6. ECOG performance status 0-1; 7. Life expectancy >=12 weeks; 8. Adequate organ and bone marrow functions. Absolute Neutrophil Count(ANC) >=1.5x10^9/L, Platelet (PLT) >=100x10^9/L, Hemoglobin(HGB) >=100 g/L, Serum albumin >=28 g/l,Thyroid stimulating hormone (TSH)50 ml/min; 9. All acute toxicity responses to prior antitumor therapy were remission to level 0-1 (according to NCI CTCAE 5.0) or to the level specified in the inclusion/exclusion criteria. Other toxicities, such as hair loss, that researchers believe pose no safety risk to patients.
Exclusion criteria
Exclusion criteria: 1. Any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with asthma which has been completely relieved in childhood and without any intervention after adults can be included; Asthma in which patients need bronchodilators for medical intervention cannot be included; 2. Current use of any immunosuppressive medication or systemic hormone therapy(dose > 10mg/ day prednisone or other therapeutic hormones)within 14 days before the first dose of anti-PD1 antibody and apatinib; 3. Known to be severe allergic to other monoclonal antibodies; 4. Patients with known history of central nervous system metastasis; 5. Patients with inability to swallow, malabsorption syndrome or any conditions affecting drug gastrointestinal absorption; 6. Ascites with clinical symptoms need to be punctured and drained or have received ascites drainage within the past 3 months, except those with small amount of ascites but no clinical symptoms shown by imaging. 7. Uncontrolled hypertension (blood pressure >140/90 mmHg after adequate treatment); 8. Clinical cardiac symptoms or diseases that cannot be well controlled, such as: (1) NYHA standard 2 or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc>450ms (male);QTc>470ms (female); 9. Coagulation dysfunction (INR>2.0, PT>16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Allowing preventive use of low-dose aspirin and low-molecular heparin; 10. Arterial/venous thrombosis events occurred within 6 months before admission, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc; 11. Known hereditary or acquired hemorrhage and thrombophilia (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); 12. Urine routine indicates urine protein >=++, and confirmed that the 24-hour urine protein > 1.0 g; 13. Abdominal fistula, gastrointestinal perforation and abdominal abscess occurred within 6 months before the study began; 14. Gastrointestinal hemorrhage or definite gastrointestinal hemorrhage tendency, such as: radioactive enteritis, radioactive gastritis, local active digestive tract ulcer focus, and persistent fecal occult blood positive; 15. Patients who received radiotherapy, chemotherapy, hormone therapy and surgery, after the treatment (the last medication), less than 4 weeks before medication; Molecular targeted therapy (including other oral targeted drugs for clinical trials) is less than 5 drug half-life from the first dose of study drug, or the adverse events caused by previous therapy (except alopecia) have not recovered to 38.5°C within 7 days before medication or white blood cell count > 15x10^9/l at baseline; 17. Patients with congenital or acquired immune dysfunction (such as HIV infection); 18. Any other malignancy in the past 3 years or concurrent malignancy (except for fully treated in situ malignant such as cutaneous basal cell carcinoma and cervical carcinoma in situ); 19. For patients with bone metastasis, palliative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR;DCR;TOR;TTF;PFS;OS; | — |
Countries
China
Contacts
Public ContactWANG HUAYING
Outcome results
None listed