Endometerial cancer
Conditions
Interventions
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Prior to the implementation of any trial-related procedures, a written informed consent shall be signed; 2. Aged >= 18 years; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 4. Histologically and/or cytologically confirmed endometrial cancer(including endometrioid adenocarcinoma, serous carcinoma, clear cell carcinoma); 5. Has progression of disease after treatment of a platinum-containing chemotherapy; 6. Life expectancy of 12 weeks or more; 7. Have at least one measurable lesion as defined by RECIST 1.1; 8. Adequate organ and bone marrow and function: 1) Blood routine:absolute neutrophil count >= 1.5 x 10^9/L, platelet, PLT >= 90 x 10^9/L, hemoglobin, HGB >= 9.0 g/dL 2) Liver:total bilirubin = 28 g/L, alkaline phosphatase = 50mL/min(Cockcroft-Gault ); 4) INR and APTT <= 1.5 ULN; 9. For female subjects with reproductive age, the urine or serum pregnancy test should be negative within three days before receiving the first administration of the researched drug (the first cycle, first day). If the urine pregnatncy test is not enough to confirm the negative results, then the blood pregnancy test is required; 10. Women of child-bearing potential must agree to use adequate contraception during study treatment, and for at least twelve weeks after the last dose of study treatment(failure rate lower than 1%). 11. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1(according to NCT CTCAE 5.0).
Exclusion criteria
Exclusion criteria: 1. Any other malignancy in the past 5 years or concurrent malignancy; 2. Prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs; 3. Prior treatment with PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other agents target to CTLA-4/OX-40/CD137; 4. History of anti-VEGF/VEGFR/RAF/MEK/PDGFR/FGFR treatment; 5. Radiotherapy within 4 weeks before the start of the study; 6. Have undergone major surgery within 4 weeks before the start of the study; 7. System antineoplastic treatment within the 2 weeks before the first dose; 8. The patient has any active autoimmune disease or a history of autoimmune disease in the 2 years before the first dose; 9. The patient is using systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones) or other immunosuppressive agents; 10. Seroperitoneum or pleural effusion not well controlled; 11. History of central nervous system metastasis; 12. History of organ allograft (Participant has had an allogenic tissue/solid organ transplant); 13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibodies (including antibody drug-conjugates or checkpoint inhibitors); 14. A known history of Human Immunodeficiency Virus (HIV); 15. Known active Hepatitis B virus infection; 16. Known active Hepatitis C virus infection; 17. Has received a vaccination within 4 weeks of planned treatment start; 18. Females who are pregnant or breastfeeding; 19. Serious diseases that not well controlled; 20. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests Abnormalities, accompanied by family or social factors, can affect the safety of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Duration of Response;Disease Control Rate;Time to Progression;Time to Response;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactBeihua Kong
Qilu Hospital of Shandong University
Outcome results
None listed