Endometrial cancer
Conditions
Interventions
Camrelizumab combined with apatinib group:Treatment with Camrelizumab with apatinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all the following selection criteria to be included in this study: 1) With my consent and signed an informed consent form, I am willing and able to comply with planned visits, research and treatment plans, laboratory inspections and other test procedures; 2) Female patients >=18 years old; 3) Patients with endometrial cancer diagnosed by histology and or cytology. 4) Patients with advanced and recurrent endometrial cancer during or after completion of systemic treatment that have received >=1 times in the past. 5) There is at least one measurable lesion (according to RECIST v1.1 requirements, the spiral CT scan of the measurable lesion has a long diameter >=10 mm or an enlarged lymph node short diameter >= 15 mm; lesions that have received local treatment in the past, according to RECIST v1.1 The standard can be used as a target lesion after the progress is clear); 6) ECOG score: 01 (see Annex 1 for ECOG scoring criteria); 7) Expected survival period >= 12 weeks; 8) Sufficient organ and bone marrow function, defined as follows (no blood components, cell growth factor drugs are allowed within 14 days before the first administration): Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count (PLT) >= 100 x 10^9/L (without corrective treatment within seven days); Hemoglobin (Hb) >= 100g/L (10g/Dl) (without corrective treatment within 7 days); Serum albumin >= 28 g/L; Thyroid-stimulating hormone (TSH) 50 mL/min; 9) All acute toxic reactions of previous anti-tumor treatments were alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified by the inclusion/exclusion criteria. Except hair loss and other toxicities which be considered by researchers that do not introduce risk to safety to patients.
Exclusion criteria
Exclusion criteria: 1) The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , Hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, without any intervention after adults can be included; patients with asthma that require bronchodilators for medical intervention cannot be included); 2) The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment; 3) Severe allergic reaction to other monoclonal antibodies; 4) Those with a known history of central nervous system metastasis; 5) Inability to swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption; 6) Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of ascites on imaging but not accompanied by clinical symptoms; 7) Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 8) Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular with clinical significance Or ventricular arrhythmia requires treatment or intervention; (5) QTc > 450ms (male); QTc > 470ms (female); 9) Abnormal blood coagulation function (INR > 2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low molecular heparin; 10) Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 11) Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); 12) Urine routine test showed urine protein >=++ and confirmed 24-hour urine protein content > 1.0 g; 13) Abdominal fistula, gastrointestinal perforation, and abdominal abscess occurred within 6 months before the start of the study; 14) Gastrointestinal bleeding or a clear gastrointestinal bleeding tendency, such as: radiation enteritis, radiation gastritis, local active peptic ulcer lesions, persistent stool occult blood positive can not be included in the group; 15) Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication; molecular targeted therapy (including other oral targeted drugs used in clinical trials) is less than the first study medication =38.5 degree C, or baseline white blood cell count > 15x10^9/L; 17) Patients with congenital or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;BOR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;TTR;DCR;DOR;PFS; | — |
Countries
China
Contacts
Public ContactQuan Chenlian
Fudan University Affiliated Tumor Hospital
Outcome results
None listed