gynecological cancers
Conditions
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Patients with gynecological cancers(endometrioid adenocarcinomaserous carcinomaclear cell carcinomacervical squamous cell carcinoma) confirmed by histopathology or cytology; 3. Patients with metastasis and recurrence of gynecological cancers after radiotherapy or surgery; 4. At least one measurable lesion; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6. Life expectancy greater than or equal to 6 months; 7. The main organs function well, and the inspection indicators meet the following requirements 1) For results of blood routine test: HB>=90g/L; ANC>=1.5x10^9/L; PLT>=100x10^9/L; 2) For results of blood biochemical test ALB>=29g/L; ALT and AST<=3 ULN; TBIL<=1.5 ULN; Serum creatinine <=1.5 ULN; 8. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 2. 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, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 3. Patients with other malignant tumors within 5 years. 4.Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA >=1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study; 5. 6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male > 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism); 6. Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or > 38.5 degreees C during screening visits or on the first scheduled day of dosing; 7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Less than 4 weeks from the last clinical trial; 9. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| LCR;DoR;PFS;OS;safety; | — |
Countries
China
Contacts
Public ContactLiu Hong
The Fourth Hospital of Hebei Medical University
Outcome results
None listed